Joopm Vol1 Ed 5 (2016)

Vol 1, No 5 (2016)

Courtesy of the Robert Pope Foundation

An open access, online journal covering all aspects of pain

ISSN 2047-0800

Vol 1, No 5 (2016) December 2016

Editor-in-Chief Dr Rajesh Munglani Pain Medicine Consultant

The Journal has been created in recognition of the fact that not all information or advances in pain medicine can be presented in a randomised controlled fashion.

Assistant Editors-in Chief Dr Turo Juhani Nurmikko Professor Chas Bountra

The Journal will publish papers on clinical practice, basic science, ethics and medico-legal aspects of pain. Issues around suffering, theological, social, psychiatric, psychological, education and resources limitations in pain medicine will also be considered.

Assistant Editors Dr Joshua Adedokun Dr Carsten Bantel Dr Ganesan Baranidharan Dr Arun Kumar Bhaskar Revd Dr Mark Quinn Bratton Rev Canon Dr Adrian Francis Chatfield Dr Neil Talbert Collighan Dr Simon Dolin Dr Andreas Goebel Dr Teodor Goroszeniuk Dr Sanjeeva Gupta Dr Shamim Haider Dr Dalvina E. Hanu-Cernat Dr Andrzej W Krรณl Dr Patrick Robert McGowan Dr Kevin Markham Dr Vivek Mehta Dr Charles Pither Dr Andrew Ravenscroft Dr Jonathan Richardson Dr Manohar Lal Sharma Dr Michael D. Spencer Dr Simon James Thomson Mr Michael Walsh Dr Chris Wells Pain Fellow Representative Dr Kiran Sachane

Contents Part One : Modic Antibiotic Spinal Therapy (MAST). Early experience in the use of antibiotics in Modic-related back pain (MRBP). A case report and prospective,open-label, observational study Dr Anthony Hammond

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Part Two: Involvement of Family and Friends in Pain Management Interventions Lucinda Mawdsley, Dr Hannah Twiddy & Melissa Longworth

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Part Three: Ultrasound guided radiofrequency procedures in chronic pain management Dr Andrzej Krol

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Part Four: Can we increase the safety of transforaminal injections? A place for injection pressure monitoring Dr Andrzej Krol

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Part Five: Should the Church interfere with the process of law making?

Lord Carey, Archbishop of Canterbury 1991-2002

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Dorsal root ganglion stimulation vs. conventional spinal cord stimulation - efficacy and patient experience of two neurostimulation methods for the treatment of Complex Regional Pain Syndrome type II: A case report.

Dr Tomasz Bendinger

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Salvaging Function in the Traumatically Injured Limb

by Trans-Tibial Amputati Professor Michael Saleh

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Copy Editors Paul Nash Louise Mantin Journal Manager Ms Katherine Dougherty KJD Communications katherine@kjdcommunications.com Journal website www.joopm.com

ISSN 2047-0800

Modic Antibiotic Spinal Therapy (MAST). Early experience in the use of antibiotics in Modic-related back pain (MRBP). A case report and prospective, open-label, observational study Dr Anthony Hammond.

1

Abstract Introduction Modic change is common in the back pain population. Recent reports of successful antibiotic therapy in post disc surgical cases of progressive Modic change and back pain raise the possibility of improvement for difficult to treat patients. I here report successful antibiotic treatment in a post disc surgical patient with progressive painful Modic change and the result of the treatment of 33 further cases of mixed aetiologies.

Case report The case of a 35-year-old patient who had undergone successful discectomy for sciatica and who subsequently developed progressive Modic Type 1 change and disabling back pain is presented. The patient showed an excellent response to MAST treatment adapted for penicillin allergy.

Methods Open-label, prospective collection of MAST standardised data in daily clinical practice by one practitioner in two settings (independent NHS and private practice) of 36 sequential cases. Other than the case reported, these patients were usual chronic spinal pain patients, not specifically post disc surgery.

Results 33 patients are available for evaluation to date. Of these: 3 were non-compliant and one withdrew consent. Of those who commenced treatment 22.3% failed to complete the 100-day course due to adverse effects. Of the 22 patients completing treatment: 40.9% were rated as excellent (>75% patient global improvement) and 27.3% were rated as good (>50%) while 22.7% failed. No major adverse events occurred.

Reductions in Roland-Morris Disability Questionnaire (RMDQ), back pain, leg pain, number of days with pain and hours per day with pain were all seen, with varying statistical significance.

1

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Kent Institute of Medicine and Surgery, Newnham Court Way, Bearsted, Kent, ME14 5FT Journal of Observational Pain Medicine – Volume 1, Number 5 (2015) ISSN 2047-0800

Discussion Retention of patients was less and overall success was less in clinical practice than in clinical trial, probably due to less stringent selection criteria but overall, sufficient levels of treatment success were achieved with acceptable side effects for the author to conclude that further exploration of MAST treatment appears justified.

Keywords: Modic Change, Modic antibiotic spinal therapy, MAST

Introduction Modic change is associated with low back pain occurring in about 6% of the general population and 46% of the low back pain population.1 Types 1 to 3 are identified with Type 1 representing end plate oedema, degeneration and regeneration, Type 2 fatty bone marrow replacement and Type 3 sclerosis. 2,3 There have been many reports of the possibility that lumbar disc disease is associated with infection. After screening with serological tests, Stirling et al reported positive results on prolonged culture in 53% of 36 surgical disc specimens, 84% of which were Propionobacterium acnes or Corynebacterium propinquum..4 To differentiate from skin contamination, Stirling studied disc material from a further 207 cases of surgery for lumbar disc herniation and disc surgery cases and compared with disc material with 26 other surgical procedures (scoliosis).5 37% of the disc herniation specimens and none of the others showed infection, suggesting this was not surgical contamination. Corsia 6 and Agarwal 7 found infection in extruded lumbar disc material in between 19 and 70% of cases, once again mainly with P acnes or related species in findings reported in abstract. It is thought that these anaerobic mouth and skin commensal organisms gain access to the disc during normal bacteraemias as a result of the neovascularisation associated with disc degeneration or herniation. 8-15 Albert et al 16 studied the association of disc infection and the evolution of Modic change prospectively over 2 years post disc surgery. Of 61 cases aspirated at the time of disc protrusion surgery, 46% showed positive cultures, 86% of which were P acnes.

Furthermore, 20 of the 25 (80 %) with anaerobic cultures developed new Modic changes in the vertebrae adjacent to the previous disc herniation, compared to 16 of the 36 (44 %) with no identified infection or aerobic bacterial infection, and these were statistically different.

The possibility that these infections could have a causative association was tested with an open-label study of antibiotic therapy. 17 32 patients who developed low back pain and Modic Type 1 change (bone oedema) 1-2 years post disc protrusion surgery were treated with Amoxicillin-Clavulanic Acid (Co-Amoxiclav) 625mg TID for 90 days. The choice of treatment was on microbiologist advice. Twenty-nine patients (90.6 %) completed the treatment and three patients dropped out due to GI side effects. At the end of treatment and at long-term follow-up (mean 10.8 months) there was both a clinically important and statistically significant (p< 0.001) improvement in all outcome measures.

Most recently, Albert and colleagues undertook a prospective, randomised, placebocontrolled trial of Co-Amoxiclav versus placebo in post-surgical cases of Modic associated back pain.18 A total of 162 patients with low back pain and Modic type1 change of at least 6 monthsâ&#x20AC;&#x2122; duration after disc protrusion surgery were treated with Co-Amoxiclav in one of two doses or placebo (half in each group). At the late behest of the Danish authorities, the treatment group was given a dose ranging treatment, with half of the treated patients receiving Co-Amoxiclav 625mg one tablet TID and half receiving 625mg, two tablets TID for 100days (Modic Antibiotic Spinal Treatment: MAST). The dose ranging was exploratory and the study was not powered to discriminate between the two doses. There were no statistical differences between

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the two treatment doses of Co-Amoxiclav, though there were numerical trends in favour of the higher treatment dose in all measured response parameters. There were clear statistical differences between active and placebo-treated patients suggesting the possibility that this regime may be an effective treatment for patients with MRBP. I therefore here report a case of typical post-surgical progressive MRBP and the results of treatment in a cohort of 33 further cases of MRBP including non-surgical instances.

Case report The patient was a 35-year-old woman with no prior history of significant spinal problems who developed typical sciatica with fully consistent MRI appearances (Figure 1) of L5/S1 disc protrusion. After failed conservative management, she was treated successfully by conventional surgical microdiscectomy in July 2013. Her leg pain resolved. However, she developed back pain which became progressive and ultimately severe. After 15 months she was referred by the consulting neurosurgeon for consideration of MAST therapy. At this point she was in severe pain, continuous daily graded 8/10cm average with frequent exacerbation to 10/10 cm on a 10cm visual analogue pain score (VAS). Her RMDQ score was 22. The pain was unrelieved

by Ibuprofen 400mg QID. It was unrelieved by rest, sleep was variable, she showed intense exercise intolerance with any attempted activity or heavier ADL (vacuuming, making a bed) resulting in severe exacerbation of pain for around 2 days (pay-back).

Repeat MRI showed significant progression of MRI appearance of Type 1 Modic change with also some end plate disruption (Figure 2). Full blood count and biochemistry were normal. ESR was 2.

Figure 1. Pre discectomy T2 weighted MRI showing L5/S1 disc protrusion and minor L5 inferior end plate changes.

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Fig 2. 15 months post surgery. T2 Gadolinium enhanced scan showing dramatic extension of Modic Type 1 change (confirmed on T1) adjacent to the operated level.

In view of the clinical situation and MRI appearances, an attempt to aspirate and culture the affected disc was made. Under conscious sedation, in main theatre with full sterile technique, a 20 gauge spinal needle was passed to the centroid of the L5/S1 disc and 5 mls of normal saline injected then re-aspirated. After a patient reaspiration, approximately 5 mls of bloody disc fluid was obtained and sent for culture in aerobic and anaerobic blood culture bottles. After 5 days, the culture was positive for Propionobacter species, confirming MRBP. Unfortunately, the patient was penicillin allergic, reporting significant rash on exposure. The favoured, but not evidence-based, alternate regime for penicillin allergic patients is Doxycycline 100mg BD for 100 days. After discussion with Microbiology colleagues, it was decided to add Rifampicin 600mg BD as an additional tissue-penetrating bactericidal antibiotic. This regime requires monthly FBC and LFT monitoring for Rifampicin-related hepatotoxicity. This was carried out successfully without event and the patient showed a prompt response, reporting symptomatic benefit at the first (30-day) follow-up. Measured response parameters before and after 100 days of MAST therapy are as shown below (Table 1).

MAST Rx

RM DQ

Back Pain

Leg Pain

Days with pain

Hours with pain

Sick

Now

Worst

Ave

Now

worst

Ave

Base line

22

9

10

9

5

5

5

28

16

0

Post

1

2

2

1

0

0

0

2

0.5

0

leave

Anal gesics

Ibup QID

0

Table 1. Patient baseline and Post adapted MAST therapy (Doxycycline and Rifampicin) pain and disability scores.

MAST Treatment Series Including the reported patient, the author has made a total of 36 prescriptions for MAST therapy in patients with low back pain attributed by the author to the associated Modic change on MRI including both Type-1, Type-2 and mixed patterns.

Four patients had prior surgery, including one disc replacement. Unlike the reported case there appeared no close temporal sequence between the surgery and the

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% Improvem ent

85%

evolution of back pain. The remaining patients were referred for assessment of chronic spinal pain. These patients therefore seem to represent the population seen in pain clinics rather than spinal surgery services. In view of the small numbers no attempt was made to analyse those with previous surgical history separately.

Average age was 51 years old with 10 male and 26 female patients. The average duration of continuous pain prior to therapy was 52.7 months (6 â&#x20AC;&#x201C; 240), the median value was 30 months.

Patients were seen in 2 distinct clinical settings. Eight were seen as NHS cases in the Horder Centre, Crowborough, a charitable independent NHS provider unit, and the remainder were seen in private practice at The Kent Institute for Medicine and Surgery, Bearsted, Maidstone, Kent. Only the global perceived benefit was collected from 7 of these 8 NHS patients due to resource difficulties. One case (non-responder) did give detailed responses and was included. The average global improvement in these NHS cases did not differ from the private cases at 50 and 58.9% respectively and they have been analysed together.

Of 36 prescriptions, 3 patients were non-compliant and did not commence treatment, leaving 33 ITT (Intention to Treat) cases, defined as those patients who received any dose of antibiotic treatment. At this time 3 cases are in progress and so there are 30 evaluable ITT (ITT/E) (Intention to Treat and available for Evaluation).

The disposition of cases and the treatments given is shown below in Table 2. Of 30 ITT/E cases, 8 withdrew: 3 because of GI side effects, 3 non-specific ill health, 1 vasculitic skin rash (on Co-Amoxiclav) which resolved on withdrawal (this patient subsequently tolerated 100 days of alternate therapy Doxycycline/Rifampicin without success). One patient withdrew consent. One patient on doxycycline alone and 2 on Doxycycline/Rifampicin combination failed due to adverse effects. 22 patients have therefore completed treatment.

ITT Population Evaluable (ITT/E) Treatment Completers Incomplete: TEAE: Rash 1, GI 3, Non-specific 3 Incomplete W/D consent Co-Amoxiclav 625mg 2 TID Doxycycline 100mg BD Doxycycline 100mg/Rifampicin 600mg BD

33 30 (90.9%) 22 (73.3%) 7 (23.3%) 1 (3.3%) 25 2 9

Table 2. The treatment disposition of 36 patients prescribed MAST treatment (TEAE: treatment emergent adverse events).

Results Data collected were equivalent to the variables recorded in previous MAST studies.

These include: RMDQ (Roland-Morris Disability Questionnaire); back pain average now, back pain worst in the last 14 days and back pain average over the last 14 days; leg pain now, leg pain worst in last 14 days leg and leg pain average over the last 14 days; the number of days in the last 28 days with pain and the hours per day with pain, excluding sleep and assuming there are maximum 16 waking hours/day. Data

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on work and absence and analgesic use were requested but were not reliably reported by patients.

The results of this prospective observational study are shown below in Tables 3 and 4. 10% of patients did not comply with prescription, one took a second opinion and withdrew. Of those who commenced, 23% (approximately) failed to complete due to adverse effects. Of those who completed the course of treatment (completers) 16% failed to respond and 9% show only moderate responses while 41% are graded excellent (>75% improved on patient global improvement VAS) and 20% are good (>50%). Detailed responses were available from 29 cases. Average RMDQ fell from 14.7 to 8.4 (42.8%), Back pain, now, worst and average from 5.2, 8, 5.5 to 3.1, 5.2, 3.4 (39.7%, 34.8%, 37.5%) respectively. Leg pain now, worst and average reduced from 1.4, 2.6, 2.1 to 0.4,1.8,0.3 respectively. Average hours with pain and hours/day with pain reduced from 27.0 and 20.9 to 13.7 and 7.9. Of these, reductions in RMDQ, worst and average back pain in last 14 days, average leg pain intensity and average hours/day with pain were statistically significant with the others non-significant in small numbers tested. A numerical trend to reduction was observed in all reported parameters (Table 4).

Statistical analysis These data are on relatively small numbers with 17 patients for whom detailed data were available. In a small number paired data were missing so conservative assumptions have been made. For example, 2 patients whose global assessment was â&#x20AC;&#x153;failedâ&#x20AC;? did not have initial back pain scores and so were assigned the same original as the recorded final score. Only 6 patients recorded leg pain. 4 of these reduced under treatment (2,5,5,6 to 0,0,0,0) but results were not significant in small numbers. In each measurement, there was a tendency to numerical reduction with variable statistical significance. 2-tailed Mann-Whitney U test was used throughout with no correction for repeated testing.

Results Incomplete Failed Excellent (>75%) Good (>50%) Moderate (>25%)

ITT/E (N=30) 8(23.3%) 5 (16.7%) 9 (30%) 6(20%) 2(6.7%)

Completers (N=22) 22 (72.7%) 22.7% 40.9% 27.3% 9.1%

Table 3. Results expressed as response quartiles for the ITT/E (ITT/evaluable) and completer population were Excellent = >75% on the patient rated global perceived benefit scale, Good = >50%, Moderate, >25% and failed = less than 25%. 1 patient worsened under treatment and was excluded from analysis

RMDQ Back pain Back pain intensity now Worst intensity in last 14 days Average intensity in last 14 days Leg pain

8

Baseline 14.7

5.2

Post MAST 8.4

3.1

% reduction 42.8% (P<0.023)

39.7% (NS)

8.0

5.2

34.8% (P<0.012)

5.5

3.4

37.5% (P<0.027

Journal of Observational Pain Medicine â&#x20AC;&#x201C; Volume 1, Number 5 (2015) ISSN 2047-0800

Leg ain intensity now Worst intensity in last 14 days Average intensity in last 14 days Number of days in 28 with pain Average hours with pain in day Patient perceived global improvement

1.4

0.4

73.4% (NS)

2.6

1.3

52.6% (NS)

2.1

0.8

64.9% (P<0.021)

27.0

13.7

49.2% (NS)

20.9

7.9

62.5% (P< 0.013)

56.5%

Table 4 Results. Baseline and post therapy response parameters collected from privately treated patients and 1 NHS case who completed treatment (n = 17).

Discussion The possibility that low grade infection with skin or oral anaerobic commensals contributes to the development of Modic change and concomitant pain is raised by the studies described and by the promising results of Albert and colleagues showing open-label and controlled responses to MAST therapy with Co-Amoxiclav in extended courses of 90 or 100 days. 17,18 The case presented here is typical of the index cases described by Albert et al with post discectomy progression of Type 1 Modic change, a positive culture for Propionobacter species and an excellent response to adapted MAST therapy. This probably represents the optimal case for selection for MAST therapy.

Only 4 of the cases reported here were post-surgical and the responses seen here support the hypothesis that patients with non surgically-related MRBP could share the same potential pathological mechanisms of bacteraemic ingress during phases of disc neovascularisation after disc injury.

Albertâ&#x20AC;&#x2122;s cases showed dominant Modic Type 1 change and this is probably the optimal clinical setting. However, Modic changes are a spectrum and Dr Albert and colleagues do not exclude Type 2 from treatment. (H Albert, personal communication). The cases treated here showed mixed radiographic patterns and extent of Modic change in the context of significant persistent back pain, and many appear to respond in an equivalent fashion to the index cases described by Albert and colleagues. However, response rates reported here are somewhat lower than Albert et al, and this presumably reflects less stringent selection criteria. Real life retention rates are also much lower than the 93% trial retention reported by Albert: 18 of 33 evaluable prescriptions there were only 22 fully completed treatments (72.7%) due to non-compliance and side effects.

The kinetics of clinical response to MAST therapy are unusual in that symptoms often do not change till approximately 80 days of treatment then rapidly reduce (Dr Albert, personal communication). Anecdotally, this was the pattern observed here with CoAmoxiclav treatment. However, with the doxycycline/Rifampicin variant for penicillin allergic cases, responses appear to be seen much earlier. There is no data on the minimum possible treatment duration. Variant regimens for penicillin allergic patients are not evidence-based.

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In the Albert trial, 18 2 doses of Co-Amoxiclav were used.; 625mg TID and 625mg 2 tabs (total 1250mg) TID. The study was not powered to show a difference and there were no statistical differences between the 2 groups. However, there was a strong trend to numerical superiority in the higher dose group and around 80% versus 60% of patients in the higher group responded. I have therefore chosen to use the higher dose regime but it would be acceptable to use the lower dose or mix the 2 doses.

There is no a-priori way of judging whether the Modic mechanism is relevant to any individual patient. However, there are certain features of the patient’s history which seem recognisable. The pain is often severe, never remits, lacks mechanical features of resolution on sitting or lying and usually persists as a throbbing discomfort overnight, intruding sleep rather than simply disturbing it when the patient moves.

The phenomenon of exercise intolerance with prolonged exacerbation on any overexertion (pay-back) is pronounced. When associated with “significant” degrees of Modic changes, as judged empirically on inspection of the current MRI, the author has felt it justified to consider MAST treatment as an option - particularly since, in the author’s opinion, there is very little alternative therapy including complex or sequential interventions or surgery which would be a credible or preferable alternative.

However, the potential adverse effects of prolonged antibiotic treatment are not trivial. Diarrhoea due to altered bowel flora is to be expected in the first few weeks and can be reduced by daily dosing of live yoghurts and OTC travellers diarrhoea remedies. Ongoing non-specific GI discomforts are common. Skin rash is a common problem with Penicillins. Treatment should be withdrawn but can be restarted at very low, incremental doses. In this series one patient suffered a significant vasculitic type purpuric rash, with no systemic effects and treatment was withdrawn. She subsequently tolerated 100 days Doxycycline and Rifampicin without benefit. Thrush occurs or recurs in those prone or with previous history and responds to the usual treatments but can mandate withdrawal. The feared complication is C. Difficile colitis. Patients should be warned that a change in bowel habit with blood, mucous, pus, fever or pain mandates withdrawal and immediate medical attention. In this study, 22% of those who commenced antibiotics failed to complete the course because of side effects, mainly GI related but one case of a self-limiting leucocytoclastic type rash was also seen.

For these reasons and issues with antibiotic overuse, there is considerable public health concern about the indiscriminate use of antibiotics in a common condition such as back pain and of course this practice is not encouraged here. Many specialists may consider it too early to adopt MAST therapy till such issues have been fully resolved, and this is a respected attitude. However, the considered prescription in carefully selected cases under specialist supervision, when other options have been assessed, tried or out-ruled may at this point none-the-less be justified for the individual in view of the high levels of disability, suffering and the societal costs associated with this condition.

In summary, in this open-label prospective study, patients so treated reduced disability by 40%, spent approximately half as much time in pain, their pain was 4060% (back and leg respectively) less severe, and on average considered themselves almost 60% improved. 63% of patients who could complete treatment were considered excellent or good. Less potentially toxic regimes and further research are needed.

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Acknowledgements The members of the public who allowed this anonymised information to be used.

Conflict of interest disclosures Disclaimers and conflict of interest policies are found at: http://bit.ly/1wqiOcl

Article submission and acceptance Date of Receipt: 10.04.2015

Date of Acceptance: 22.05.2016

Contact information Dr Anthony Hammond ,Consultant Physician and Rheumatologist The Kent Institute of Medicine and Surgery, Newnham Court Way Bearsted. Kent, ME14 5FT, 01622 538093, michelle.burgess@kims.org.uk

References 1. Jensen TS, Karppinen J, Sorensen JS, Niinima¨ki J, Leboeuf-Yde C. Prevalence of vertebral endplate signal (Modic) changes and their association with non-specific low back pain—A systematic literature review. Eur Spine J. 2008; 17:1407–22 2. Modic MT, Masaryk TJ, Ross JS, Carter JR. Imaging of degenerative disc disease. Radiology. 1988; 168:177–86 3. Modic MT, Steinberg PM, Ross JS, Masaryk TJ, Carter JR. Degenerative disc disease: assessment of changes in vertebra body marrow with MR imaging. Radiology. 1988; 166:193–9 4 Stirling A, Worthington T, Rafiq M, Lambert PA, Elliott TS. Association between sciatica and propionibacterium acnes. 2001; Lancet 357:2024-5 5 Stirling AJ, Jiggins M. Association between sciatica and skin commensals. 2002 International Society for the Study of the Lumbar Spine, Cleveland.

6. Corsia MF, Wack M, Denys G. Low virulence bacterial infections of intervertebral discs and the resultant spinal disease processes. 2003; Abstract from Scoliosis Research Society (SRS) annual meeting 7. Agarwal VJ, Golish R, Kondrashov D, Alamin TF. Results of bacterial culture from surgically excised intervertebral disc in 52 patients undergoing primary lumbar disc microdiscectomy at a single level. 2010; Spine J 10:S45–S46 8. Bhanji S, Williams B, Sheller B, Elwood T, Mancl L. Transient bacteremia induced by tooth brushing: a comparison of the Sonicare toothbrush with a conventional toothbrush. Pediatr Dent. 2002; 24:295–9 9. Roberts GJ, Holzel HS, Sury MR. Dental bacteremia in children. Pediatr Cardiol. 1997; 18:24–7 10. Farrar MD, Ingham E. Acne: inflammation. Clin Dermatol. 2004; 22:380–4 11. Doita M, Kanatani T, Harada T, Mizuno K. Immunohistologic study of the ruptured intervertebral disc of the lumbar spine. Spine. 1996; 21:235–41 12. Hirabayashi S, Kumano K, Tsuiki T, Eguchi M, Ikeda S. A dorsally displaced free fragment of lumbar disc herniation and its interesting histologic findings. A case report. 1990; Spine. 15:1231–3 13. Ito T, Yamada M, Ikuta F et al. Histologic evidence of absorption of sequestration-type herniated disc. Spine.

1996; 21:230–4 14. Lindblom K, Hultquist G. Absorption of protruded disc tissue. J Bone Joint Surg. 1950; 32:557–60 15. Gronblad M, Virri J, Tolonen J et al. A controlled immunohistochemical study of inflammatory cells in disc herniation tissue. Spine. 1994; 19:2744-51 16. Albert HB, Rollason J, Lambert P et al. Is the herniated nucleus material in lumbar disc herniations infected with bacteria, and does the infection cause Modic changes in the surrounding vertebrae? (Submitted to European Spine) 17. Albert HB, Manniche C, Sorensen JS, Deleuran BW. Antibiotic treatment in patients with low-back pain associated with Modic changes Type 1 (bone oedema): a pilot study. Br J Sports Med. 2008; 42:969–73 18 Albert HB, Sorensen JS, Christensen BS, Manniche C. Antibiotic treatment in patients with chronic low back pain and vertebral bone oedema (Modic Type 1 changes): a double-blind randomized clinical controlled trial of efficacy.

2013; Eur Spine J 2(4):697-707

Intellectual property & copyright statement We as the authors of this article retain intellectual property right on the content of this article. We as the authors of this article assert and retain legal responsibility for this article. We fully absolve the editors and company of JoOPM of any legal responsibility from the publication of our article on their website. Copyright 2016. This is an open-access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution and reproduction in any medium, provided the original work is properly cited.

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Involvement of Family and Friends in Pain Management Interventions 1

1

Lucinda Mawdsley , Dr Hannah Twiddy & Melissa Longworth

1

Abstract Context/Background: Chronic pain (CP) is a major public health concern affecting 7.8 million people in the UK alone.1 Family members and close friends play an important role in supporting those with CP. Previous research demonstrates that it is not solely the individual diagnosed with CP that is affected, but also significant others such as family and friends (F&F).

Objectives: The current study will consider the role of F&F in supporting individuals with CP to adjust to life with pain, and aims to demonstrate the importance of their involvement on a pain management programme (PMP).

Method: A new F&F session was added to a well-established PMP based at the Walton Centre NHS Foundation Trust in Liverpool, UK. A mixed methods questionnaire-based service evaluation was conducted over a period of six months to determine the usefulness and value of F&F involvement on a PMP from the perspective of patients and their F&F. Results: Quantitative data highlighted positive perceptions of the session, with 65.4% of participants rating the session content as ‘very good’ and 71% rating session usefulness as ‘very good’. A thematic analysis further revealed high satisfaction levels in how the session improved understanding of self-management approaches (42.2%), communication techniques (22.8%) and satisfaction reported by patients around having a F&F present on the programme (13.3%).

Conclusions: The inclusion of significant others on a PMP was shown to be a valuable addition to the established group programme. It is valued both by patients, and F&F alike, and is in line with previous findings that carer inclusion can be crucial in supporting the development of self-management strategies and support.

Limitations of the study include its cross-sectional design and variation of session delivery.

Key words Chronic Pain, Family and Friends, Pain Management, Intervention, PMP

1

Pain Management Programme, The Walton Centre NHS Foundation Trust, Liverpool, UK

Journal of Observational Pain Medicine – Volume 1, Number 5 (2015) ISSN 2047-0800

Introduction Chronic Pain

Chronic pain (CP) is a major public health concern affecting 7.8 million people in the UK alone1. CP is defined as prolonged and persistent pain lasting at least 3 months in duration.2 While an acute pain response to noxious stimuli has a vital protective function, CP conditions constitute a tremendous source of unnecessary suffering.3 The extent of chronic pain poses a significant economic burden on patients and the systems around them, including societies, health care services and families.4 CP is a condition that has high comorbidity with depression and other mental health difficulties.5 Pain itself is shaped by a host of psychological factors, and how individuals react to the physiological aspects of pain is shaped and influenced by their previous experience.6 Psychological effects may include fatigue, depression and anxiety.7 Social withdrawal and isolation further contribute to the negative experience of CP. The complex effects of living with CP have been well documented in the literature and can be understood within a biopsychosocial framework. Along with the personal and social consequences of CP, individuals often report receiving a multitude of negative attitudes and distrust from health care providers, colleagues, family members and acquaintances.8

Pain Management Programmes A PMP is a psychologically-based rehabilitative intervention for people with CP which remains unresolved by other treatments currently available. PMPs are wellestablished interventions for individuals with notable pain-related distress and reduced quality of life (QoL). It is delivered in a group setting by an interdisciplinary team of experienced health care professionals working closely with patients.2 A PMP provides a secure environment for patients to learn about CP from an experienced multidisciplinary team of professionals in order to understand the links between CP and the subsequent impact pain has on various aspects of life. Being in a group setting with others experiencing CP is greatly beneficial to patients and results in a collaborative learning environment between patients and professionals.

The role of carers in Chronic Pain Although CP has significant consequences for the individual affected, its impact also affects those in their immediate social sphere; typically family members and close friends. The experience of CP is all-encompassing, affecting all aspects of life as seen in other chronic conditions.9 Previous research has noted value in examining the interaction between an individualâ&#x20AC;&#x2122;s response to their condition and the social relationships that they inhabit in their environment.10 The family environment encompasses a range of variables including individual parent behaviours, dyadic interactions between family members and the broader family system including socioeconomic conditions, family structure, functioning and culture.11 Family members and close friends therefore have a vital role in supporting individuals with their self-management of CP. It has been noted that the spouse of the CP patient has an important influence on patient coping and adjustment to life with pain. 12 13 14 15 In keeping with this, research has looked at spouse-assisted training in pain coping skills.16

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CP can cause significant limitations on family life and social roles,17 and can result in role shifts within the family.18 For example, physical implications posed by CP mean that activity such as household chores, childcare, leisure activities and work become troublesome. Restructuring of familial roles occurs to compensate for the responsibilities that the individual with CP once took care of. This can include children taking on caring roles and responsibilities that were previously shouldered by a parent. Such role restructuring may have implications for self-identity. The roles and patterns of activity within a family are often well-established and disruption brought about by CP can cause frustration and distress for all involved as adjusting to and accepting new roles and relationship dynamics can cause unease in F&F relationships. Relatives of individuals with CP have reported feeling powerless, alienated, emotionally distressed and isolated.19 Previous research looking at the experience of partners of people living with CP has also highlighted themes of family loss, life changes, the emotional impact of pain and consequences for future plans that couples or families may have once made together.19 Furthermore, the invisibility of CP can lead to discrepancies between patients’ and spouses’ appraisals of pain severity and this may lead to patients feeling disbelieved and misunderstood by their spouse and close others.20 Increased caring responsibility can place demands on individuals struggling to adjust to the changes brought about by CP and this can place significant burden on those individuals placed in the caring role. Burden of care is a complex construct that is usually defined by its impact and consequences on caregivers.21 22 Such tensions may cause significant others to be a potentially detrimental source of support rather than an aid to rehabilitation through promoting quality of life (QoL) and functioning.21 Many theories have proposed as frameworks to understanding the role of the family in mediating pain responses. Expressed Emotions (EE) theory23 describes how highly hostile and critical family environments may interact with an individual’s vulnerability to stress to exacerbate and maintain a variety of conditions. It has been suggested that this theory could be extended to CP, with spouse criticism or hostility aggravating and maintaining CP intensity or pain behaviours.24 According to interpersonal models, 25 spouses of individuals with CP may become frustrated when pain does not improve and when adverse lifestyle changes become seemingly longlasting.26 Witnessing pain talk and/or pain behaviour may then elicit a negative response from spouses towards the individual with CP.27 These negative responses may have a detrimental effect on patient and spouse well-being. Some research has looked to attachment theory 28 to explain the family-pain interplay. In a study where individuals with CP completed measures of self-reported attachment style, perceived spouse responses, and pain-related criterion variables, it was found that secure attachment was inversely associated with self-reported pain behaviours, pain intensity, disability, depressive symptoms and perceived negative spousal responses.

Fearful and preoccupied attachment scores were positively associated with these variables.29 The dynamic interplay between the social environment and psychosocial adjustment30 means it is important to consider the wider impact of CP when providing pain management interventions and to recognise the interface between condition management and family life.31 Significant others may play a mediating role in pain outcomes and patient support and it is becoming increasingly acknowledged that involving partners or significant others in pain management and taking psychosocial factors (including spousal response to development and maintenance of pain) into account are important elements in management of pain.32 Involving significant others in pain management interventions may increase the likelihood that the social environment will foster behaviour change and persistence with management techniques.33 This is especially important since lifestyle changes 14

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brought about by CP may undermine support and may increase unhelpful spousal responses.27 The complexity of these dyadic interactions must be taken into account when delivering pain management interventions,15 as offering education and support for family members may aid positive responses to pain interventions. Therefore, the influence of spouses and significant others is an important aspect of pain management that must not be overlooked.21

Content for the addition of a Family and Friends afternoon on the PMP

CP can therefore cause families to be faced with significant challenges.16 Pain management interventions should consider the wider impact of CP and the significant lifestyle alterations CP brings about, not just to individuals diagnosed, but also to those in the individual’s immediate social sphere. Systemic work involving F&F may therefore be important in assisting with rehabilitation.

Cognitive behavioural interventions can change patient beliefs around pain and this suggests that the beliefs of spouses and F&F are also amenable to change.34 In the context of evidence surrounding the importance of including significant others in CP rehabilitation the PMP team at the Walton Centre, Liverpool, added a F&F afternoon to an established PMP. This afternoon aimed to introduce F&F to the philosophy of a PMP and its core themes in order to help establish understanding of CP (vs. acute pain) and appropriate support and communication between the individual with CP and significant others. The potential social stigma faced by individuals with ‘unseen’ health complaints21 and their families is also explored.

Study aims

The aim of this study was to assess the perceived effectiveness and value of adding a F&F session to an established, structured PMP from the perspective of patients and their F&F. A second aim was to add to the current literature published in this area and highlight important findings.

Methods Participants Participants included a mixture of patients and their F&F who attended the F&F session on a 16 day PMP during the six-month period that data collection took place.

The average age of those attending the programme was 46.3 years (47.83 years for females and 46.87 years for males) and of the total 720 patients, 497 were female and 223 were male.

Materials Data was collected anonymously using a questionnaire design (see Appendix A).

Participation in the service evaluation was voluntary and all attendees of the F&F session of a 16 day PMP during the six-month data collection period had the opportunity to take part.

Design The study was a mixed method questionnaire-based service evaluation, taking place over a period of six months. The questionnaire looked at ratings of various aspects of 15

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the session including content, speed and usefulness alongside what was rated to be the most and least useful parts of the session.

Procedure A F&F session was added to the Walton Centre’s established PMP. This session occurred on the 8th day of a 16 day PMP and lasted approximately 2.5 hours with one 15 minute break half way through. F&F sessions were facilitated by a Clinical Psychologist, a Physiotherapist and an Occupational Therapist who specialised in CP; reflecting the interdisciplinary approach of a PMP. Each discipline outlined core themes from their speciality regarding the impact of CP on an individual’s life and the role of management approaches in these areas (See Table 1).

Table 1 – Key Areas Addressed in the PMP Family & Friends Session

Discipline Clinical Psychology

Occupational Therapy

Physiotherapy

The Clinical Psychologist involved in the session has an overarching aim to explore and develop family, friends and patients’ understanding of the impact of chronic pain alongside acceptance of living with pain. The second main focus is on communication and improvement of techniques between patients and their F&F. The Occupational Therapist has the aim of exploring the varied and widespread impact that pain can have on functioning, lifestyle, activity and roles. They introduce ideas and techniques discussed on the programme, including the concepts of target setting, activity pacing and the use of mindfulness techniques. This provides information to allow F&F to support the patient during the programme and in the future. It also highlights the emphasis of returning to activity that is realistic and valued by the individual.

The Physiotherapist highlights the differences between types of pain and the impact of pain on physical functioning. They explore past management of pain and the importance of a gradual increase in activity throughout the programme to improve mobility and quality of life, despite pain.

Results The final study sample included 179 participants, 96 of which were patients on the PMP, 74 were family members, 3 were friends and 6 were unspecified. Both quantitative and qualitative data was collected to assess the perceived usefulness and value of the F&F sessions on the PMP and to further highlight individual satisfaction and suggestions.

Quantitative Data Results highlighted that 65.4% of participants rated the session content as ‘very good’ (score 5 on the Likert scale), 48% rated the speed of delivery as ‘very good’ and 71% rated usefulness of the sessions as ‘very good’. No participants rated the content, speed or usefulness as ‘poor’ or ‘very poor’ (see Table 2 for an outline of percentage 16

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ratings from the Likert scale of satisfaction).

Qualitative Data A thematic analysis of open-ended satisfaction questions showed how participants rated the most useful aspects covered to be improving understanding of selfmanagement approaches to chronic pain (42.2%), communication techniques (22.8%) and the presence of a F&F (13.3%). Alternatively, the least useful aspects were reported to be the group setting itself (28.6%), improving understanding of selfmanagement approaches to chronic pain (28.6%) and the shortness of the session length (16.7%).

Table 2 - Percentage Rating of Content, Speed and Usefulness of the PMP Family & Friends Session

Content (%) N = 176

Speed (%) N = 176

Usefulness (%) N = 176

Very Poor (1)

0

0

0

Poor (2)

0

0

0

Okay (3)

3.91

7.26

4.47

Good (4)

29.1

42.5

22.9

Very Good (5)

65.4

48

70.95

Discussion In line with the aim of this article, the authors believe that the results demonstrate the potential effectiveness of a F&F session as part of a PMP for patients, family and friends. Specifically, the majority of participants selected â&#x20AC;&#x2DC;very goodâ&#x20AC;&#x2122; in all three satisfaction areas (content, speed and usefulness, as highlighted in Table 2). The interpretation of these results is that those involved found the content of the group and applicability to be relevant, the speed of delivery to be at an appropriate pace and the usefulness to daily life to be at a high level. Qualitative data further revealed how participants found the session to be of particular use. These findings together are consistent with the increasing acknowledgement within the literature that involving significant others in the management of CP is important.32 Group aspects that were reported to be less useful were also explored and recorded.

One common theme included the group setting itself, with participants reporting the environment to be too large and noisy. A number of participants reported feeling uncomfortable expressing their feelings within the group space, while others expressed how they would have liked the session to be longer in duration. It would therefore be important within future groups to address these factors by considering appropriate group numbers, group location and the length of the session. The third theme highlighted that a number of participants reported that their understanding of self-management approaches to chronic pain did not improve, due to already acquiring a good level of understanding. This was therefore rated as a least useful 17

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aspect of the session. As this was reported to be very useful for some of the group and less useful by others, it would be helpful to explore further other potential factors that may underpin this varied finding, while tailoring content to various levels of current understanding.

The above results highlight important key components and areas of focus for future sessions. It is clear that F&F inclusion can benefit new and established PMPs due to the perceived value reported by CP patients and F&F. This inclusion has the further potential to improve patient programme experience, increase perceived social support and even offer indirect support to F&F. Participants also felt their communication abilities improved from attending the session, which will likely add to their perceived level of support from others.

To explore usefulness and patient satisfaction of a F&F session, future studies would benefit from implementing a longitudinal study design to capture how these outcomes may change over time. More specifically, conducting a longitudinal study may highlight the likelihood of behaviour change and persistence with management techniques in patients and F&F, as proposed previously.33 As the current study featured a cross-sectional design, this information cannot be derived. Similarly, exploring group expectations prior to the session may allow services to either accommodate for or modify these to encourage positive outcomes and satisfaction in all areas. Secondly, as sessions were facilitated by different team members, this potentially led to variance in delivery and consequential feedback. To account for this variance, additional statistical tests should be run on larger sets of data to explore if this relationship moderates changes in satisfaction or group outcomes. Thirdly, outcomes were based on session satisfaction only and it may be of benefit to incorporate health-related and psychosocial outcomes in future research. These scores alongside satisfaction feedback will encourage understanding of other potential moderating factors and more varied outcomes, including changes in emotional distress, feelings of being powerless and being isolated as identified previously.19 Incorporation of an objective measure of expressed emotion such as the Camberwell Family Interview35 may add rich data around whether or not F&F would perceive the session as useful or not, depending on family environment and involvement. Finally, F&F sessions could similarly be incorporated into individual rehabilitation settings to promote similar outcomes.

Future implications Analysis of both quantitative and qualitative data in the current sample highlights how the management of CP in services could be improved by the addition of F&F involvement. Not only did this serve to educate individuals around effective management of pain in this sample, further reported benefits included perceived social support through F&F attendance and improvement in communication abilities.

This has potential to positively influence long-term outcomes as F&F would feel more confident in their ability to support their loved one in a variety of situations, increasing feelings of efficacy and control in both patients and those around them.

This should be taken into account when developing interventions for individuals with CP in the future, whether group based or individually tailored, in order to improve perceived support, understanding and overall outcomes.

Conclusions In conclusion, the F&F session delivered at the Walton Centre, Liverpool was reported to be a valuable component of the PMP which was consistent across both 18

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PMP patients and their F&F alike. This corroborates with previous findings that carer inclusion can be crucial in the development of self-management strategies. Further exploration into ways of improving the group session and addressing aspects deemed to be less helpful may further improve the experience of future patients and F&F. Overall, the influence of spouses and significant others is an important part of pain management that could be a beneficial addition to PMPs. Acknowledgements

The authors would like to thank all members of the Pain Management Programme team at the Walton Centre NHS Foundation Trust, Liverpool UK. Conflict of interest disclosures The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Disclaimers and conflict of interest policies are found at: http://bit.ly/1wqiOcl

Article submission and acceptance Date of Receipt: 10.11.2015

Date of Acceptance: 20.05.2016

References

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4 Phillips

CJ, Schopflocher D. The economics of Chronic Pain. Health Policy Perspectives on Chronic Pain. Rashiq S, Schopflocher D, Taenzer P, Jonsson E. Weinheim, Germany: Wiley-Blackwell; 2008 5 Miller

LR, Cano A. Comorbid chronic pain and depression: who is at risk? J Pain, 2009; 10(6): 619-627.

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SJ, Shaw WS. Impact of psychological factors in the experience of pain. Phys Ther, 2011; 91(5): 700-711.

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SJ. A review of psychological risk factors in back and neck pain. Spine, 2000; 25(9): 1148-1156.

8 Breivik

H, Collett B, Ventafridda V, Cohen R, Gallacher, D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain, 2006; 10(4): 287-333.

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HG, Kraft B. Opioid medication and driving ability. Eur J Pain, 2005; 9(2): 141-144.

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483 11 Palermo

TM, Holley AL. The importance of the family environment in pediatric chronic pain. JAMA Pediatr, 2013; 167(1): 93-94.

12 Turk

DC, Rudy TE, Flor H. Why a family perspective for pain? Int J Fam Ther, 1985; 7(4): 223-234.

13 Flor

H, Turk DC, Rudy TE. Pain and families. II. Assessment and treatment. Pain, 1987; 30(1): 29-45 14 Schwartz

L, Edhe DM. Couples and Chronic Pain. The Psychology of Couples and Illness. Schmaling KB, Goldman ST, editor. Washington, DC: American Psychological Association, 2000

15 Newton-John

TR, de C Williams AC. Chronic pain couples: Perceived marital interactions and pain behaviours. Pain, 2006; 123(1): 53-63.

16 Abbasi

M, Dehghani M, Keefe FJ, Jafari H, Behtash H, Shams J. Spouse-assisted training in pain coping skills and the outcome of multidisciplinary pain management for chronic low back pain treatment: A 1-year randomized controlled trial. Eur J Pain, 2012; 16(7): 1033-1043.

17 Strunin

L, Boden LI. Family consequences of chronic back pain. Soc Sci Med, 2004; 58(7): 1385-1393.

18 Blanchard

A, Hodgson J, Lamson A, Dosser D. Lived Experiences of Adult Children Who Have a Parent Diagnosed with Parkinson’s Disease. The Qualitative Report, 2009; 14(1): 61-80.

19 West

C, Usher K, Foster K, Stewart L. Chronic pain and the family: the experience of the partners of people living with chronic pain. J Clin Nurs, 2012; 21(23-24): 33523360.

20 Kool

MB, Van Middendorp H, Bijlsma JW, Geenen R. Patient and spouse appraisals of health status in rheumatoid arthritis and fibromyalgia: discrepancies and associations with invalidation. Clin Exp Rheumatol, 2011; 29(6 Suppl 69): S63-9.

21 Brooks

J, McCluskey S, King N, Burton K. Illness perceptions in the context of differing work participation outcomes: exploring the influence of significant others in persistent back pain. BMC musculoskelet disord, 2013; 14(1): 48.

22 Vaingankar

JA, Subramaniam M, Abdin E, He VY, Chong SA. “How much can I take?”: predictors of perceived burden for relatives of people with chronic illness.

Ann Acad Med Singapore, 2012; 41(5): 212-20.

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GW, Monck EM, Carstairs GM, Wing JK. Influence of family life on the course of schizophrenic illness. Br J Prev Soc Med, 1962; 16(2): 55-68.

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JA, Levine JD. The contributions of interpersonal conflict to chronic pain in the presence or absence of organic pathology. Pain, 1991; 44(1): 35-43.

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SF, Henderson PR, Tasca GA. An interpersonally based model of chronic pain: an application of attachment theory. Clin Psychol Rev, 1994; 14(1): 1-16.

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KM, Knafl KA. Living with chronic pain: the spouse's perspective. Pain, 1985; 23(3): 259-271.

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LP, Romano JM, Jensen MP, Thorn BE. Attachment style is associated with perceived spouse responses and pain-related outcomes. Rehab Psych, 2012; 57(4): 290.

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MT, Cano A. Pain affects spouses too: Personal experience with pain and catastrophizing as correlates of spouse distress. Pain, 2006; 126(1): 139-146

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LR, Cano A, Wurm, LH. A motivational therapeutic assessment improves pain, mood, and relationship satisfaction in couples with chronic pain. J Pain, 2013; 14(5): 525-537.

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Corresponding Author: Hannah Twiddy, Pain Management Programme, The Walton Centre NHS Foundation Trust, Jubilee House, Longmoor Lane, Fazakerley, Liverpool L9 7LJ, UK. Email: Hannah.twiddy@thewaltoncentre.nhs.uk

Intellectual property & copyright statement We as the authors of this article retain intellectual property right on the content of this article. We as the authors of this article assert and retain legal responsibility for this article. We fully absolve the editors and company of JoOPM of any legal responsibility from the publication of our article on their website. Copyright 2016. This is an open-access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution and reproduction in any medium, provided the original work is properly cited.

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Ultrasound guided radiofrequency procedures in chronic pain management Dr Andrzej Krol, MD, DEAA, FRCA, FFPMRCA

Abstract Radiofrequency treatment for chronic pain management is still fighting its position in evidence based medicine hierarchy ladder. Variability of human tissue and subjectivity of pain perception are known factors affecting outcomes of clinical trials.

Radiofrequency lesion size depends on many factors and precision in active tip positioning is a key factor to successful treatment. Ultrasound alone or in combination with fluoroscopy may further increase precision in neural structure targeting, thus improving outcome and increasing safety. In a very short overview, this author highlights procedures where ultrasound has changed our clinical practice and where ultrasound works better in combination with fluoroscopy. After a decade of introducing ultrasound into contemporary pain interventional practice there is a call for a critical review.

Keywords Radiofrequency, ultrasound, chronic pain

Introduction Radiofrequency procedures have been successfully applied over the last few decades in various medical specialties including interventional cardiology, radiology, vascular surgery, dermatology and last, but not least in pain management. Radiofrequency lesioning involves the generation of a very high frequency alternating current (300500 kHz), from RF generator, delivered through an electrode, via a insulated cannula with the RF energy delivered at the exposed active tip aimed at the target neural structure.

At the inauguration of the first issue of the Journal of Observational Pain Medicine, the Editor in Chief Dr Rajesh Munglani quoted Sir Bradford Hill, creator of the first ever randomized clinical trial: “ Another problem lies in the biological variation of the human material with which we have to deal. Can we make a useful trial if that variability is very great” 1 It could have not been truer about the efficacy of radiofrequency in chronic pain management.

In addition to variabilities of human perceptions of pain, right diagnosis and indication for procedure there are also several factors affecting actual the RF lesion size:

§ § §

Needle size Active tip size Duration Journal of Observational Pain Medicine – Volume 1, Number 5 (2015) ISSN 2047-0800

23

§ § § § §

Temperature Bipolar lesion Multiple lesions Cooled RF Pre-injection fluid

Any combination of the above-mentioned parameters may result in desirable lesion size2, but on balance, due consideration is to be observed regarding the safety of the targeted neural tissue and neighbour structures such as motor nerves, vessels and other vital organs.

Provenzano investigated extensively the influence of specific fluid pre-injection on lesion size 3,4, but the most practical message came from another study showing that pre-injection of steroids reduce lesion size 5. It is recommended that if steroids are to be used, as it is common practice in the UK, it should be done only after, and not before the lesioning.

Pulsed radiofrequency is a relatively newer technique that divides opinions evens amongst experts and raises even more questions than answers 6,7 . The concept of delivering similar amount of energy in pulses without creating a heat lesion but producing a neuromodulation effect predominantly on A-delta and C fibres has been well proven in animal studies 8, but translation into clinical practice is still inconsistent. What’s is the optimal duration, frequency, pulse width, voltage for the given human tissue and distance from the needle? Complexities of those interactions have been elegantly explained on the clinical example of radicular pain9.

The Future of Interventional Pain Medicine Along with accurate diagnosis and patient selection, precise targeting for neuroablative therapy are the benchmarks for the future of interventional pain medicine9. Recently, detailed anatomical studies have shed new light on the final active tip positionings for cervical medial branch ablation and sacroiliac joint denervation10,11.

Role of Ultrasound in Radiofrequency Procedures Ultrasound has brought in a new dimension to interventional pain management, although compared to its influence in regional anaesthesia, the uptake has been much slower. Chronic pain physicians have already been using image-guided interventions such as fluoroscopy and CT and feel confident with their armamentarium. There are and will be technical limitations of ultrasound: different structures to be targeted, often deeper and less well-defined than peripheral nerves, limited experience and formal training and also paucity of evidence and relevant publications. Between 1982 and 2002 there were only three publications related to ultrasound guided techniques in chronic pain management, but the amount of publications in this field has been growing steadily into several hundreds by now13 In the last few years, prominent position in literature has been gained by publications including “Atlas of Ultrasound Guided Procedures in Interventional Pain Medicine” edited by Prof. Samer Narouze14 and “Recommendations for Education and Training

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24 in Ultrasound-Guided Interventional Pain Procedures” by ASRA, ESRA and AAFPS joint committee15. More recently, CIPS (Certified Interventional Pain Sonologist) exam has been introduced under the auspices of the World Institute of Pain. Author online survey in 2012 revealed that almost half of the UK Pain Physicians have been using ultrasound in daily clinical practice and there has been growing interest in access to more training16,17 This author along with Dr Barry Nicholls and RA-UK organize a yearly training course and hands-on workshop - Ultrasound in Pain Medicine (USPM) in London; this course has a renowned international faculty and has been hugely popular in attracting candidates from all over the world.

Up-to date evidence and experience suggests dividing ultrasound guided procedures in at least two categories as shown on the below.

All of the structures shown in Table 1 can be identified clearly solely using ultrasound, thus increasing precision, safety, reducing cost and procedure time; this would be changing clinical practice positively.

Table 1 Radiofrequency procedures performed under ultrasound guidance Greater Occipital Nerve Cervical Roots Stellate Ganglion Suprascapular nerve Genicular Nerves Other peripheral nerves Joints- shoulder, knee, hip Trigger Points This author is a great advocate of combining fluoroscopy with ultrasound when indicated as shown in Table 2. It helps to compare to the existing “gold-standard” technique, to identify the desired level straight away without additional scanning; this is especially important for medial branches and intercostal nerves. It has been shown to reduce the total procedure time, amount of X-ray radiation and also increased the operator confidence and patient safety as showed on example of sacroiliac joint denervation 18 Table 2 Radiofrequency procedures where ultrasound complement fluoroscopy Cervical medial branch Lumbar medial branch Intercostal nerves Sacroiliac joint

Cervical medial branch is a very good example of combining both techniques.

Fluoroscopy helps to define the desired level and initial needle direction. Ultrasound 24

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25 helps to position the needle parallel to the medial branch along the articular pillar and identify surrounding neurovascular structures such as the vertebral artery, radicular artery and the anterior nerve root before proceeding to perform a thermal lesion and therefore increasing safety as well precision of the procedure as illustrated in Figure 1 below

Figure 1

Example of combined ultrasound and fluoroscopy for cervical medial branch radiofrequency denervation. a) Lateral and A-P view of fluoroscopy images in patient in prone position. Note needle “ tunnel vision” in A-P position. Lateral view shows needle position at the level of articular pillar from single entry point b) Ultrasound probe position in longitudal and transverse neck scans to assess needle position. c) Ultrasound images in transverse scan. Needle alongside and close to the articular pillar, parallel to the medial branch

Modern ultrasound machines have various softwares such as beam steering and other navigation systems to reduce scattering and improve needle visibility.

Operator has to be aware of the system capability to optimize image. The size of the needle will also increase visibility but often at the cost of patient discomfort if awake or lightly sedated. Needle guidance systems such as Sonix GPS has been introduced recently to improve needle trajectory especially for deeper structures such a lumbar medial branch block19.

Radiofrequency echogenic needles has been evaluated by the author. Standard RF cannula and echogenic cannula are shown (See Figure 2) at the decreasing angle to the US beam : 75 °, 60°, 45°. There is noticeable difference of needle visibility, but only at the angle below 60°

25

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26

Figure 2

Figure 2 – Images to demonstrate standard and echogenic RF needles at different angle to the beam : 75° , 60°, 45° a) Standard RF needle b) Echogenic RF needle

Conclusions Radiofrequency procedures for chronic pain under ultrasound guidance are becoming increasingly popular, merging experience from musculoskeletal (MSK) ultrasound such as diagnostic imaging, joint injection and interventions used typically under fluoroscopy or CT guidance. Precise final RF cannula position may not only increase effectiveness of radiofrequency treatment, but also improve safety .

The author acknowledges that more robust evidence is to be gathered. Avoiding ionising radiation and the portability of equipment are other important advantages.

Pain physicians practicing interventional pain management should consider ultrasound use in their daily practice for radiofrequency procedure

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27

Acknowledgements Author would like to thank Mr Ciaran Wazir for enormous organizational and administrative work with regards to USPM, London and other courses and the London Pain Forum Council: Dr Teodor Goroszeniuk, Dr Rajesh Munglani, Dr Arun Bhaskar for their enthusiasm and support in promoting multidisciplinary pain education.

Article submission and acceptance Date of Receipt: 31.05.2015

Date of Acceptance: 20.05.2016

Conflict of interest disclosures 1

Author received lecture honoraria from B-Braun, Phillips and equipment loan from Sonosite Disclaimers and conflict of interest policies are found at: http://bit.ly/1wqiOcl

References 1

Munglani R How do we progress knowledge , Pain News, Winter 2011: pp 33-35 Cosman ER Jr, Dolensky J R, Hoffman RA Factors That Affect Radiofrequency Heat Lesion Size. Pain Med. 2014 Dec;15(12):2020-36 2

. Provenzano DA, Lassila HC, Somers D. The effect of fluid injection on lesion size during radiofrequency treatment. Reg Anesth Pain Med . 2010;35:338–342.

3

4

Provenzano DA, Liebert MA, Somers DL. Increasing the NaCl concentration of the preinjected solution enhances monopolar radiofrequency lesion size. Reg Anesth Pain Med . 2013;38:112–123.

5

Tiyaprasertkul W, Perez J Injection of steroids before Radiofrequency Ablation Has a Negative Impact on Lesion Size, RAPM 2014, 39(3): 189-191, 6

Sluijter ME, Cosman ER, Rittman WB, Van Kleef M The effects of pulsed radiofrequency field applied to the dorsal root ganglion: a preliminary report. Pain Clin 1998;11:109-117 7

Munglani R The longer term effect of pulsed radiofrequency for neuropathic pain. Pain 1999;80:437-439

8

Erdine S, Bilir A, Cosman ER, Cosman ER Jr.Ultrastructural changes in axons following exposure to pulsed radiofrequency fields. Pain Pract. 2009; 9: 407–417.

9

Van Boxem K, Huntoon M, Van Zundert J, Patijn J, Van Kleef M, Joosten EA. Pulsed Radiofrequency: A review of the Basic Science as Applied to the Pathophysiology of Radicular Pain. RAPM 2014 , 39(2) :149-159, 10

Cohen SP, Precision Targeting for Neuroablative Therapies: The Future of Interventional Pain Medicine, RAPM, 2014, 39(6):447-449 11 Kweon TD, Ji YK Lee HY, Kim MH, Lee Y-W Anatomical Analysis of Medial Branches of Dorsal Rami of Cervical Nerves for Radiofrequency Thermocoagulation, RAPM, 2014, 39(6):465-471 12

Roberts SL, Burnham RS, Ravichandiran K, Agur AM, Loh EY. Cadaveric Study of Sacroiliac Joint Innervation Implications for Diagnostic Blocks and Radiofrequency Ablation. RAPM, 2014, 39(6):456-464

Peng, Philip W.H.; Narouze, Samer Ultrasound-Guided Interventional Procedures in Pain Medicine: A Review Anatomy, Sonoanatomy, and Procedures: Part I: Nonaxial Structures RAPM. 34(5):458-474, September/October 2009.

14 . Narouze, Samer N. ( Editor) Atlas of Ultrasound Guided Procedures in Interventional Pain Management, Springer 2011 15 Samer N. Narouze, Provenzano D ,Peng P, Eichenberger U , Lee, S CH, Nicholls B, Moriggl B Recommendations for Education Training in Ultrasound –Guided Interventional Pain Procedures. RAPM 2012;37:657-664 13

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Tavakkolizadeh M, Anandakrishnan S, Krol A. “Current UK practice of ultrasound guided pain management procedures”; Proceedings , NWAC World Anesthesia Convention in Istanbul: April 2012

17

Tavakkolizadeh M , Krol A Curriculum design for training in ultrasound guided pain management procedures.

Proceedings , World Congress on Pain, Milan, August 2012

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Krol, A , Ponnussamy, K , Evans N. , Nicolaou A Ultrasound assisted Simplicity III probe placement for SIJ radiofrequency denervation- case report and description of the novel technique. JoOPM 2014 Vol 1 ( 4):84-91

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Gofeld M, Brown MN, Bollag R, Hanlon JG, Theodore BR. Magnetic Positioning System and Ultrasound Guidance for Lumbar Zygapophysial Radiofrequency Neurotomy. A Cadaver Study. RAPM 2014;39 (1) :61-66

Contacts/correspondence Dr Andrzej Krol, Anaesthetic Department & Chronic Pain Service, St George’s Hospital, Blackshaw Road, Tooting, London, SW 17 0QT andrzej.krol@stgeorges.nhs.uk

Intellectual property & copyright statement We as the authors of this article retain intellectual property right on the content of this article. We as the authors of this article assert and retain legal responsibility for this article. We fully absolve the editors and company of JoOPM of any legal responsibility from the publication of our article on their website. Copyright 2016. This is an open-access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution and reproduction in any medium, provided the original work is properly cited.

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Can we increase the safety of transforaminal injections? A place for injection pressure monitoring Dr Andrzej Krol, MD, DEAA, FRCA, FFPMRCA

Abstract Transforaminal epidural steroids injections ( TFESI) have been successfully used for treating radicular pain originating from cervical, thoracic and lumbar spine although not without complications. Suggestions for improving the safety of epidural steroids injections has been published very recently in JAMA.1 In this short review the author will raise awareness of yet another overlooked factor which may contribute specifically to the safety of transforaminal perineural injections: injection pressure monitoring.

Keywords Transforaminal steroids, injection pressure monitoring, safety

Introduction - Complications of transforaminal injections Transforaminal epidural steroid injections (TFESI) or selective nerve roots blocks (SNRB) have been well established in interventional pain practice. Sufficient evidence exists to support such an intervention in clinical situations of radicular pain as both diagnostic and therapeutic measures. 2,3 Complications are uncommon, but when they occur they may have a significant impact on the well-being of the patient as well as put an enormous pressure on the providers. Eight cases of paraplegia have been reported after lumbar transforaminal injections of steroids. In all cases particulate steroids have been used and direct involvement of the Adamkiewicz artery confirmed. The anterior radicularis magna artery (Adamkiewicz) provides the major blood supply to the spinal cord; it originates on the aorta left side at the level of T8-L1 in 75% of the population but may arise at L2 level in 10% and even lower in 1% of people.4 Not surprisingly, in the cervical region with more complex anatomy: - the spinal cord and emerging neural structures, the vertebral artery, the radicular artery, the spinal segmental artery, the ascending cervical artery and the deep cervical artery, to mention but a few - the toll of severe complications is even higher. The American Pain Society reported 78 neurologic complications involving brain or spinal cord infarction. 5, 6,7 In most but not all cases, particulate steroids were to blame. An animal study confirmed fatality when the particulate steroids were injected into the vertebral and carotid artery, but good recovery if non particulate steroids were used.8, 9 Therefore it has become established practice to use non particulate steroids, at least in the cervical region.

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Injection pressure monitoring per se would be unable to detect intravascular needle placement. One can speculate that pressure and flow may have a role along with viscosity of fluid in substance distribution. High injection pressure may indicate intraneural needle position but uncontrolled rate of injection around dura or epineurium will create higher pressure around delicate neural and vascular structures. 10,11 Complications of TFESI remain anecdotal thus it would be very difficult to prove that any single precaution or its combination could minimise the risk of serious untoward events.

Image guidance and procedure safety Sufficient training in image guided interventions is essential to reduce the adverse incidence. Guidelines for performing TFESI have been published by various societies.12 Some argue against the routine use of the cervical root injection; others recommend a CT guided procedure. 13,14 In fact, CT has been found neither more accurate nor safer.5 There is indeed imperfection and under-appreciation of the surrounding anatomical structures in fluoroscopy guided technique. Preprocedural review of MRI scan to optimise needle trajectory has been recently emphasised by Nishio.15 The author of this short paper, along with others â&#x20AC;&#x201C; Narouze16, Yamouchi 17advocates the use of ultrasound point of care to monitor needle pathway and appreciate surrounding vascular and neural structures. The combination of ultrasound with fluoroscopy has brought another safety margin, allowing for assessment of contrast spread. Although extraforaminal spread is observed in the majority of cases, clinical results for both steroids and pulsed - radiofrequency have been encouraging. Example of US guided extraforaminal cervical root injection confirmed with fluoroscopy and dye injection are presented in Fig 1

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Figure 1

Figure 1 Pictures above show a)

Skeleton model with needle approaching C7 cervical root

b)

Live patient in lateral position for ultrasound guided cervical nerve root block

c)

Cadaveric dissection showing dye around C5 nerve root after US guided block

d)

Ultrasound picture showing anatomical structures during C6 nerve root block Th-thyroid gland, SCM- sternocleidomastoid muscle, CA- carotid artery, LC- longus colli muscle, AT- anterior tubercle of the C6 transverse process, C6- Nerve root

e)

Ultrasound picture showing anatomical structures during C7 nerve root block

f)

Annotated pictures showing needle approaching C7 nerve root .Note other roots of plexus

g)

Fluoroscopy showing extraforaminal contrast spread after C6 nerve root block

PT-posterior tubercle, C7- nerve root, VA-vertebral artery

h)

Fluoroscopy showing both extraforaminal and epidural contrast spread after C7 nerve root block

i)

Ultrasound picture of needle next to C6 nerve root

Role of injection pressure monitoring in avoidance of intraneural injection- the evidence The Hagen–Poiseuille equation describes the relationship between pressure, fluid viscosity, tube length, diameter and flow rate for Newtonian non compressible fluid during laminar flow through the tube of constant diameter . The author’s group investigated the relationship between different needle gauge, length and fluid viscosity in relation to injection pressure and rate of injection. As the injection rate increases up to 0.4ml/s, injection pressure was negligible, less than 15 psi (775 mmHg), regardless of needle diameter, length and fluid injected (normal saline, lignocaine, bupivacaine, methylprednisolone). The relationship in vivo was far more complicated, but for the study presented, opening injection pressure was defined as the pressure peak that followed the initiation of the injection. Injection pressure 31

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monitoring could be another safety factor which might be introduced to the wider clinical practice. Selander et al., seeking an explanation of inadvertent spinal anaesthesia following peripheral nerve block close to the spine, found it most likely to happen after intraneural needle placement and associated with high injection pressure. 19 In a clinical study of lumbar plexus block, Gadsen et al. demonstrated that high injection pressure (>20psi) resulted in contralateral spread in 50% of cases.10 Keeping injection pressure below 15-20 psi may prevent untoward spread and its clinical consequences. Moreover, our group confirmed in recent cadaveric study statistically significant difference between intraneural and perineural injections for median, radial and ulnar nerves using low volume of normal saline and slow rate of injections 0.1ml/s. 20 The results were consistent with other cadaveric study showing even higher intraneural pressure for roots of brachial plexus with mean peak pressure 48.9 psi.21

Figure 2

50 40

Psi

30

In tr a n e u r a l P r e s s u r e 20

E x tr a n e u r a l P r e s s u re

10 0 M e d ia n N e r v e

R a d ia l N e r v e

U ln a r N e r v e

Figure 2 â&#x20AC;&#x201C; Bar graph above shows the intraneural and perineural pressure of the median, radial and ulnar nerves following injections of 1.0ml saline with a flow rate of 0.1ml/s using a 21G 80mm needle. The data is statistically significant across all three nerves. The P values are: Median P<0.01, Radial P<0.002, Ulnar P <0.16. (Paired t-test was used n=10).

We have also learned from previous studies that subjective individual feeling is not reliable enough to determine injection pressure. In one study, although anaesthesiologists perceived an increase in the force required to inject, 70% used pressure greater than 20 psi.22 In another study only 30% of anaesthetists rightly recognised intraneural needle position by syringe feel in an animal model provided. 23

Why monitor injection pressure during trans / extraforaminal injections?

Conclusion Nerve injury following regional blocks has always been of great concern to anaesthetists. Peripheral nerve injury after regional anaesthesia (RA), although a very rare event, may lead to significant disability and trigger litigation. Most reviews, regardless of methodology to identify the nerve, quote incidents of 1:2500-5000.

Overall incidents of nerve damage after pain relieving injections are unknown. Most complications have been presented as case reports and case series, therefore true 32

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numbers are difficult to quote. There is a risk of a “double crush” injury if a primary indication for intervention is nerve compression within the foramen or spinal canal.

All possible precautions should be taken to avoid harm. Maintaining low injection pressure may prevent neural damage as well as inadvertent spread of injected solution. False positive readings may occur once the needle tip is obstructed by sitting directly against a bone, ligament, tendon or if the injection rate exceeds 0.4ml/s. If injection pressure monitoring is to be accepted in routine practice the device should be reliable, easy to use, simple, disposable and inexpensive. In the modern understanding of evidence based medicine it would be impossible to prove its value as severe incidents are extremely rare.5 However, comparison with the safety of general anaesthesia seems to be in place. Over the years, thanks to advanced monitoring and training, mortality from general anaesthesia alone has reduced from 1:1000 in the 1950s to 1:500 000 in the 21st century. Complications of TFESI are very low but we should take all available steps to minimise the risk even further and use a combination of measures as proposed in Table 1 below: Table 1

Transforaminal / Extraforaminal Injections Safety Ladder

§

Pre-procedure MRI assessment

§

Patient awake / light sedation

§

Image guidance: Fluoroscopy/ Ultrasound/ CT as appropriate

§

Injection pressure < 15-20 psi

§

Injection rate < 0.4ml/s

§

Stimulation at 0.2mA consider intraneural placement ( for P-RF techniques)

§

Blunt tip needle

Fig. 3 demonstrates fluoroscopy guided L5 SNRB with in-line injection pressure monitor

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Figure 3

Acknowledgements

a) Fluoroscopy oblique view for L5 Selective nerve root block. Needle in “ tunnel vision” b) A-P fluoroscopy view. Contrast spread along targeted L5 nerve root nerve as well as epidural c) In-line pressure monitor during contrast injection d) In-line pressure monitor during local/ methylprednisolone injection

Conflict of interest disclosures Disclaimers and conflict of interest policies are found at: http://bit.ly/1wqiOcl The author received lecture honoraria from B-Brown, Phillips and equipment loan from Sonosite

Article submission and acceptance Date of Receipt: 10 April 2015

Date of Acceptance: 22 May 2016

The author would like to thank Mr Ciaran Wazir for enormous organisational and administrative work with regards to USPM, London and other courses and the London Pain Forum Council, Dr Teodor Goroszeniuk, Dr Rajesh Munglani and Dr Arun Bhaskar for their enthusiasm and support in promoting multidisciplinary pain education.

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References 1

Benzon HT, Huntoon MA, Rathmell JP. Improving the safety of epidural steroid injections. JAMA May 5, 2015; 313, Number 17: 1713-1714 2

Manchikanti L, Buenaventura,RM, Manchikanti KM, Ruan X, Gupta S, Smith HS, et al. Effectiveness of therapeutic lumbar transforaminal epidural steroid injections in managing lumbar spinal pain. Systematic Review , Pain Physician 2012;15:E199-E245 3

Van Zundert J, Patijn J, Hartrick CT, Lataster A, Huygen FJP, Mekhail N, et al. Evidence-based interventional pain medicine: according to clinical diagnoses. pp 18-30; 71-86, John Wiley & Sons, Ltd; 2012 Luyendijk W, Cohn B, Rejger V, Vielvoye GJ (1988). "The great radicular artery of Adamkiewicz in man.

Demonstration of a possibility to predict its functional territory". Acta neurochirurgica 95 (3–4): 143–6.

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Neal JM, Rathmell JP, Complications in regional anaesthesia and pain medicine.2012; pp:309-16 ISBN-10:1-45110978-4 6 Scanlon GC, Moeller-Bertram T, Romanovsky SM, Wallace MS. Cervical transforaminal epidural steroid injections: more dangerous than we think? Spine. 2007; 15:1249-1256 5

Benny B, Azari P, Briones D. Complications of cervical transforaminal epidural steroid injections. Am J Phys Med Rehabil. 2010,89:601-607

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8 Okubadejo GO, Talcott MR, Schmidt RE, et al.Perils of intravascular methylprednisolone injection into the vertebral artery. An animal study. JBJS(Am). 2008; 90:1932-1938

Dawley JD, Moeller-Bertram T, Wallace MS, Patel PM. Intra-arterial injection in the rat brain: evaluation of steroids used for transforaminal epidurals. Spine (Phila Pa 1976). 2009; 34:1638-1643

9

10 Gadsen JC, Lindenmuth DM, Hadzic A, Xu D, Somasundarum et al. Lumbar plexus block using high-pressure injection leads to contralateral and epidural spread. Anesthesiology.2008;109:683-688 11 Vala A., Phylactides L., Krol A, Szarko M. Identifying a threshold for the speed of local anaesthetic to be used with B Smart device to avoid “false positive” results. Reg Anesth Pain Med. 2015; 40 (S1) ESRAS-0192.

12 Bogduk N Cervical transforaminal access. In: ISIS Practice Guidelines for Spinal Diagnostic and Treatment Procedures. 2nd ed. Sa Rafael CA: International Spine Intervention Society. 2013;257-271

Provenzano DA, Fanciullo G. Cervical transforaminal epidural steroid injections: should we be performing them? Reg Anesth Pain Med. 2007; 32: 168–177.

13

14

Suresh S, Berman J, Connell DA. Cerebellar and brainstem infarction as a complication of CT-guided transforaminal cervical nerve root block. Skeletal Radiol. 2007 May;36(5):449-52.

Nishio I. Cervical transforaminal epidural steroid injections: A proposal for optimizing the preprocedural evaluation with available imaging. RAPM.2014;39:546-549

15

16 Narouze SN. Ultrasound guided cervical nerve root block. In Atlas of ultrasound guided procedures in interventional pain management.125-130, Springer; 2011 17 Yamouchi M, Suzuki D, Nilya T et al. Ultrasound guided cervical nerve root block: spread of solution and clinical effect. Pain Medicine 2011;12:1190-1195 18 Vala A., Phylactides L., Krol A, Szarko M. Identifying a threshold for the speed of local anaesthetic to be used with B Smart device to avoid “false positive” results. Reg Anesth Pain Med. 2015; 40 (S1) ESRAS-0192

Selander D, Sjostrand J. Longitudinalal spread of intraneurally injected local anaesthetic. Acta Anaesth Scand.

1978;:22( 6):622—634

19

Krol A, Szarko M, Vala, A, De Andres J. Pressure monitoring of intraneural and perineural injections into median radial and ulnar nerves; lesson from cadaveric study, Anesth Pain Med.2015; June:5(300)e: 22723

20

Orebaugh SL, MukalelJJ, Krediet AC, Weimer J, Filip P, Mc Fadden K, et al.. Brachial plexus root injection in a human cadaver model: Injectate distribution and effect on neuraxis. RAPM. 2012; 37(5):525-529

21

Claudio R, Hadzic A, Shih H, Vloka JD,,Castro J, Koscielniak-Nielsen Z, et al. Injection pressure by anesthesiologists during simulated peripheral nerve block. RAPM. 2004;29:201-205

22

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Theron PS, Mackay Z, Gonzalez JG, Donaldson N, Blanco R. An animal model of” syringe feel” during peripheral block. RAPM. 2009; 34:330-332

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Contacts/correspondence Dr Andrzej Krol, Anaesthetic Department & Chronic Pain Service, St George’s Hospital, Blackshaw Road, Tooting, London, SW 17 0QT andrzej.krol@stgeorges.nhs.uk

Intellectual property & copyright statement We as the authors of this article retain intellectual property right on the content of this article. We as the authors of this article assert and retain legal responsibility for this article. We fully absolve the editors and company of JoOPM of any legal responsibility from the publication of our article on their website. Copyright 2016. This is an open-access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution and reproduction in any medium, provided the original work is properly cited.

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Should the Church interfere with the process of law making?

Lord Carey, Archbishop of Canterbury 1991-2002

Keynote address Cambridge Annual Medico-Legal Conference 25th September 2015 I am grateful to Dr. Munglani for the invitation to be with you this evening. I am greatly impressed by your medico-legal conference where you examine, in close detail, issues where your disciplines meet.

I represent an entirely different profession which, as I will show, has had close links with medicine and law in the past.

If I were to get you to vote on the question: ‘Is religion a power for good in the world?’

I guess most of us would instinctively say ‘No’. Of course, on reflection you might then qualify this because of your upbringing and experience. You might conclude that undoubtedly religion has been associated with human flourishing since the beginning of time. But when we glance at what is happening in the Middle East at the moment, when we think of the Israeli/Palestine problem, when we think of terrorism on our doorstep, religion may well reveal itself as an ugly and brutal thing. My wife and I are involved with a charity that works closely with the World Bank. There is an unspoken sentiment among bank staff: ‘Keep away from religions because they are dangerous, divisive and decadent’. It makes some of us, who are doing all we can to make the world a better place, wince.

Here in Britain, we have a different kind of problem. A growing secularism is creating a growing gulf between the churches and the rest of the population. Many people show very little interest in matters of faith in spite of the high profile that the Church has in the media. It is extraordinary, for example, that the Guardian, of all papers, had a few days ago a front page trumpeting divisions in the Anglican Communion, with a picture of the back of the Archbishop of Canterbury in his full robes of office!

Why was that paper so interested in that story and presented it in such a strange way? Why is it that our voice is often heard in the media, whilst at the same time, the world seems to be walking away? So, at one level, society seems uninterested in the message of Christianity and yet at the same time the church is here visible in so many ways, yet in danger of being sidelined, ignored and at times questioned about its relevance.

Could it be that one of the dangers about the gulf between the churches and the society it seeks to serve is that society will lose its cultural memory of what it owes to the Christian faith and what might result if this continues?

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Here is a story I heard a few years ago. A group of 40-year-old women teachers met to decide where they should go for their anniversary lunch. It was agreed that they should meet at the Ocean View restaurant because the waiters there were handsome and sexy. 10 years later at the age of 50 they discussed where they should meet for lunch. It was agreed that they should meet at the Ocean View restaurant because the food was very good and the waiters were cute. 10 years later at the age of 60 the women discussed where they should meet for lunch and they agreed that they would go to the Ocean View restaurant because you could eat there in peace and quiet, the restaurant had wonderful views and the waiters were sweet boys. Ten years later at the age of 70 the women discussed where they should meet for lunch and agreed that they would meet at the Ocean View restaurant because the restaurant had wheel chair access, even had an elevator and the waiters were kindly. Ten years later at the age of 80, the women discussed where they should go for their anniversary. Finally, they decided that they would meet at the Ocean View restaurant because they hadn’t been there before. Loss of memory.

The doctors present will agree that there is nothing as sad and as terrible as the person who is slowly but definitely being ‘un-personed’ as Alzheimers takes hold. It is a thing we all dread. So it is when a society loses its memory of what it owes to great forces in culture and history.

Let me comment on the historic links between Church and medicine but, before I do so, allow me to make a general point.

The importance of Christianity in the formation of Western civilization surely cannot be denied. Even though the European Union a few years ago tried to airbrush Christianity out of its history, the attempt was nonsense. The rather feeble retort that Western civilization owes more to Greek thought and to the Enlightenment forgets that it was the Christian church which conveyed Greek and Roman literature through the dark ages to modern times. As for the Enlightenment – which I personally do not see as in any sense an opponent of Christian thought – most of our values, notions of justice and human rights were already in position before the rise of thinkers who fought for independent thinking.

As for medicine, there is an impressive link between church and medicine which goes back to the earliest days of the church. Not many people are aware that soon after Christianity became the official religion of the Roman Empire, monks like Basil of Caesarea were building hospitals for sick people. Basil had a 300-bed hospital built in Caesarea. It was the first large scale hospital for the ill, disabled and victims of plague. Others followed his lead and hospices were built, some within the monasteries and convents. In the so-called Dark Ages hospitals were built around monasteries, with the Benedictine Order particularly standing out. Those of you who are Welsh should be proud of St. David’s example. He focused on two things: education and care of the sick. In that, he was simply following the Benedictine tradition. The same tendency we can trace in the Middle Ages, as we think of hospitals in London such as St. Bart’s, St. Thomas’s and at least three other St. Mary’s, St. Mary Bethlem and, on the way out of London towards Canterbury, a hospital called ‘Maison Dieu’.

Among the great pioneers of medicine are those whose lives were shaped by the Christian faith and ethics. Consider, for example, Thomas Sydenham, sometimes called the ‘English Hippocrates’, whose work as a doctor was based on his understanding of the Christian faith.

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But the list of Christian doctors who shaped your great profession is impressive.

Think of the inventor of the stethoscope, Laennec, a Catholic; what about the Lutheran George Still of King’s College, whose name is associated with Still’s disease; what about James Simpson and chloroform; and Edward Jenner, a devout Christian man, to whom we are indebted for the beginnings of immunology. Indeed, there are so many Christian believers in the story of medicine including Willan, Blackmore, Willis, Fox, Daniel Drake, W. H. Welch, Howard Kelly, Ephraim McDowell and John Howard.

Then, of course, no study would be content without mentioning the promotion of medicine abroad. David Livingstone is often applauded as the great explorer but his real importance was in his compassion for the sick. He was the very first of what we now call ‘medical missionaries’. We then think of Albert Schweitzer, doctor, theologian and musician who left a brilliant career behind him to spend the rest of his life in Lambaréné in the Gabon, Paul Brand and leprosy, Ida Scudder who established the famous Vellore Medical College in South India.

Again, I could trace the link between the Christian faith and medicine up to present times with the aim fof showing the enormous contribution that Christian doctors and scientists have made to the practice of medicine. And the driving force for this has been a common desire to better the lives of others. When I became Archbishop of Canterbury I was astonished to learn that Archbishops of Canterbury had been medical Registrars for the whole of England until the beginning of the 19th century!

Go to Lambeth Palace and view the 20 volumes of the Madness of King George III. Amazing, isn’t it, that for a considerable period of English history a surgeon-barber might be engaged to give you a haircut or take a limb off! Choose wisely!

It is when we turn to law that we find again close links between the Christian faith and the practice of law. I mentioned earlier the attempt by some to ‘airbrush’ Christianity out of our history by giving to pagan thought and to the enlightenment an authority and preeminence that is not deserved. And this is true of the law. Earlier this year we thought about the Magna Carta and its impact on the Western world and particularly the United States. But the Magna Carta was no ‘stand alone’ monument to the beginnings of democracy. It was all of a piece with what was happening in Europe at the time. Larry Siedentop’s excellent book Inventing the Individual, explores the origins of Western liberalism and does not find it in either Greek or Roman thought but in the Christian understanding of the person. He shows, I think quite convincingly, that we have to place the Magna Carta in the setting of Canon Law in growing European universities in places like Bologna, Rome and the Sorbonne.

Siedentop shows how the Christian understanding of the moral law inherent in all people - rich, poor, slave, free, male and female - reached out and overlapped with social law, which ordered all society. So in the medieval and indeed up to recent times, lawyers saw no separation between their own faith as Christians and their duty as lawyers.

I find it interesting that in the development of law the model of ‘covenant’ plays a significant role. Within this model of law we can trace the idea of life as sacred, human beings as inherently flawed yet people with dignity and inalienable rights as citizens. However, with such rights go social responsibilities and duties. Thus, understood as covenant, the relationship between a lawyer and a client is a close and interdependent reciprocal relationship. The lawyer needs his client, not merely because of the money but more importantly, to practice the law and contribute to social harmony. This may not sound particularly religious but, in a deeper sense of what the Magna Carta meant in establishing the principle that law was made for man and not man for the law, is a gospel principle enunciated by Christ himself.

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This reminds me of my tussles with the law a few years ago when I was attempting to defend a number of Christians who had lost their employment because a change in the law meant that they were now on the wrong side of justice. You may remember the situation of Lillian Ladele, a black nonconformist Christian, who was the Registrar for marriages in Islington. She felt in all conscience that she could not officiate at the marriage of a same sex couple and she lost her position. There was also the case of Gary McFarlane who was a marriage guidance counsellor. He too lost his job because he could not counsel same sex couples. Although I personally did not share the views of the people concerned, I was astonished that no accommodation could be found for such courageous and well-meaning people. When I contributed a statement to the Court I was told by Lord Justice Law that we are a ‘secular land and not a theocracy’. I was astonished! There was nothing in my statement that could be construed as an argument for theocracy, but I was intrigued by his dismissal of our land as one that owed so much to the Christian faith. As Professor Simon Lee points out in his contribution to Magna Carta, Religion and the Rule of Law, it is very difficult to avoid the Scylla and Charybdis argument of, on the one hand, absolutist religious convictions and a crude secular utilitarianism on the other (p. 323). On this occasion when I received the sharp rebuke of Lord Justice Law I believe he was associating me with absolute theocratic views. We have not had a chance to meet to see if there is a medium position in which agreement could be found. That is something I regret.

Let me now return to my starting point of the growing gap between the church and the world and what might be done to reverse the trend. Possibly Raj has been wondering when I would get around to the title in the programme ‘Should the Church interfere with the process of law making?’. Let me offer three closing thoughts.

First, any organization that focuses on conserving as the most important thing is doomed to die. It will become a fossil, and that is what the church must heed. I find in the gospels a greatly neglected passage where Jesus says: ‘People do not pour new wine into old wineskins. If they do, the skins will burst; the wine will run out and the wineskins will be ruined. No, they pour new wine into new wineskins, and both are preserved.’ The freshness of faith demands that we should honour the past but resist the temptation to be fossilized by it and always seek new ways of doing things where it is appropriate.

In recent months I have been associated with two areas where I have been out of step with my church, and in both these areas medicine and law are leading players: the two areas are Mitochondrial Donation and Assisted Dying. In my opposition to the Church’s position in no way was I saying that I am right and the church is wrong. But I find it discouraging when, in both instances, those speaking for the Church seem to do so from a deep-seated resistance to change. This has been the pattern too often in the past - the theory of evolution, slavery, where apart from William Wilberforce the Church did not distinguish itself greatly in being on the side of the slaves, or rights for women. Even when James Simpson started using chloroform with women in childbirth, many in the church objected. But as you probably know, James Simpson, who knew his bible as well as others, drew attention to the second account of creation where we read God made a deep sleep to fall on Adam. Simpson cleverly remarked: ‘There, the first ever recorded account of anaesthesia’. Perhaps it was because a man was the patient – Adam - that no objections to the use of chloroform ever followed!

Secondly, let us never be silenced by bullying voices that insist that religious beliefs should not impinge on the public square. Neither the Church nor any other profession should ever interfere with the law, but helping to shape good law is a role for us all. I note, for example, that in the recent debate in the House of Commons on Assisted Dying, Crispin Blunt said: ‘This is an issue of freedom of choice. I 40

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understand the Catholic and faith lobby, whilst being appalled that they should seek to legislate my personal autonomy for reasons of their faith. In the 21st Century mutual tolerance should have taken us beyond that’. As someone who is on the same side of the debate as Crispin Blunt, and who also believes that there are good reasons why the law should be changed, I find it puzzling that someone who believes in freedom should be ‘appalled’ that religious people contribute to public debate. Is this not special pleading? Much as I disagree with the Church’s position, I fully understand its desire to protect the most vulnerable and to argue for what is best for the ‘common good’.

My third point is this: I am confident in the strength of the Church to hold its own whatever the challenges that surround us. What it has contributed to the past - to medicine, to law, to education, to social capital and to our great civilization – is remarkable and will continue. The Church in all its manifestations throughout the world is serving its peoples well, even if in my opinion it could do better. What is less clear, however, is what becomes of a nation that loses its collective memory of what it owes to the Church.

But let me close on a positive note. I am reminded of something that G.K. Chesterton wrote in The Everlasting Man in which he says that it is unwise to rule out the resurgence of the faith; indeed, Chesterton argued, not only did Jesus rise again, but the faith of Jesus Christ has had many resurrections.

Chesterton describes the five deaths where Christianity seemed on the brink of extinction. First, when the Roman Empire fell and it would have been quite natural for the Church to die out then, along with the faiths of Rome. But it didn’t. It would have been understandable for the same faith to crumble before the hordes of Muslims that swept across northern Africa and invaded Europe- but it didn’t. It would have been credible if the faith had perished as feudalism gave way to the Renaissance, but that didn’t happen either. Or when at the Reformation and following, the ancient regimes perished, but the church emerged stronger than ever. And it would have been so understandable if the faith had waned during the 19th century when Christianity was dismissed by Karl Marx, challenged by Charles Darwin, denounced by Nietzsche and explained away by Freud. ‘Time and again,’ Chesterton said, ‘The Faith has gone to the dogs but each time, it was the dog that died ’.

George Carey

Conflict of interest disclosures Disclaimers and conflict of interest policies are found at: http://bit.ly/1wqiOcl

Article submission and acceptance Date of Receipt: 04.10.2015

Date of Acceptance: 04.11.2015

Intellectual property & copyright statement We as the authors of this article retain intellectual property right on the content of this article. We as the authors of this article assert and retain legal responsibility for this article. We fully absolve the editors and company of JoOPM of any legal responsibility from the publication of our article on their website. Copyright 2016. This is an open-access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution and reproduction in any medium, provided the original work is properly cited.

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Dorsal root ganglion stimulation vs. conventional spinal cord stimulation - efficacy and patient experience of two neurostimulation methods for the treatment of Complex Regional Pain Syndrome type II: A case report.

Tomasz Bendinger MD PhD FRCA FFPMRCA EDRA and Nick Plunkett FRCA FFPMANZCA 1 FFPMRCA

Abstract Objectives: To compare the effectiveness and patient experience of conventional spinal cord stimulation vs. dorsal root ganglion stimulation as treatment modalities for Complex Regional Pain Syndrome (CRPS) type II.

Material and methods: A 39-year-old woman with CRPS type II of the right foot, diagnosed according to Budapest Criteria, received conventional Spinal Cord Stimulation (SCS) after unsuccessful conventional medical therapy. Due to a lack of effectiveness of conventional SCS, as a consequence of lead migration and positional changes of stimulation induced paraesthesia, nine months post implantation the patient was considered for revision of SCS lead. Dorsal Root Ganglion (DRG) was chosen due to growing evidence of non-inferiority over conventional SCS for patients with distal extremities pain, with reduced incidence of lead migration.

Results: After trial of stimulation, with a single right L5 DRG lead, which provided substantial pain relief and excellent topographical coverage, a permanent implantable pulse generator (IPG) was implanted. Three and six months after implantation, the patient experienced 80-90% pain relief and significant improvement of foot function. Patient overall impression of improvement was much higher after DRG stimulation, which was more tolerable and less positional in its effect compared with conventional SCS.

Conclusion: Placement of DRG stimulation provided better relief and higher patient overall impression of improvement than conventional SCS. There is a need for more direct comparisons of different types of neuromodulation techniques.

Key words: Complex Regional Pain Syndrome, spinal cord stimulation, dorsal root ganglion stimulation

1

Northern General Hospital, Sheffield Teaching Hospitals, Sheffield, UK

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Introduction Complex Regional Pain Syndrome (CRPS) is a chronic pain condition characterized by a variety of vasomotor, sensory, sudomotor, and motor and trophic signs and symptoms. The aetiology of this condition remains unknown, although a number of pathophysiological processes have been proposed. Diagnostic criteria, introduced by the International Association for the Study of Pain (IASP) in 1994 and modified in 2007 (the Budapest Criteria), improved diagnostic specificity. Two forms of CRPS have been distinguished, types I and II, differentiated by the presence of peripheral nerve injury in the latter.

To date, there is no curative treatment of CRPS and management should be focused on functional restoration of the affected limb by physiotherapy supported with pharmacological, psychological and invasive interventions.

There is emerging evidence for neuromodulation methods, which achieved National Institute for Health and Care Excellence (NICE) approval as a treatment modality in the UK, without concluding which mode of stimulation is superior.

Case Report Background history A 39-year-old-lady contracted CRPS type II after the elective excision of Mortonâ&#x20AC;&#x2122;s neuroma from her right foot, associated with injury to superficial peroneal and plantar nerves. Initially symptoms were managed conservatively and included: anti-convulsants and opioid based analgesics, guanethidine blocks and a Pain Management Programme. Despite multimodal and multidisciplinary team input the patient has never achieved significant symptom reduction.

Conventional SCS treatment The patient was considered for SCS due to treatment refractory symptoms and signs, which included: severe pain, especially over the dorsum of the foot, vasomotor signs - colour changes and cold sensation - allodynia and movement limitations. The patient underwent multidisciplinary assessment, including medical and psychological review, which did not identify any relevant issues. A successful trial of spinal cord stimulation was done with single octad lead in the epidural space, tip at the level of upper end plate of T11, followed by second stage implantation of implantable pulse generator (IPG) (Figure 1a). First follow up (at one month) confirmed that the pain was reduced by 50% and the patient was pleased with this; however, she did not reduce her medications: gabapentin 300mg TDS, tramadol 100mg TDS, buprenorphine patch 10 mcg/hr, oramorph prn, up to 3 x 10mg daily. 3-month follow up revealed reduced stimulation area coverage but still considerable 60-70% benefit in terms of pain reduction. Reprogramming providing two channel stimulation dependent on patient position (one for sitting and another for standing and lying) improved positional stimulation of the anterior thigh. At 9-month follow up the patient lost the stimulation induced paresthesia to dorsum of right foot (which was her index pain), instead experiencing additional stimulation which could, depending on truncal position, affect the right thigh and lower abdomen. Her physical function deteriorated; she had to use two crutches to walk. A further reprogramming of SCS did not improve paresthesia coverage or pain relief. X-ray confirmed a cranial movement of the lead by one electrode (Figure 1b). Despite best efforts the stimulation coverage could not be optimised, indicating the need for SCS lead revision.

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Figure 1. Lumbar spine X-ray showing the position of: a) the lead of conventional SCS after implantation; b) the lead migration of conventional SCS lead at 9-month follow up; c) the position of DRG stimulator.

a)

b)

c)

DRG stimulation DRG stimulation was chosen to target specifically the index pain area in the dorsum of the foot and to decrease risk of lead migration. The patient underwent two stage DRG implantation at right L5 level (Figure 1c). During the first follow up, at one month, the patient was very pleased with the outcome of DRG stimulation, which covered her painful area precisely. There was no positional effect, allowing the patient to use the device continuously. Her pain intensity was reduced by 70% and she stopped using any opioidbased analgesics. Her sleep improved from 2 hours to 5-hour episodes of undisturbed sleep per night. At three-month follow up the patient reported the DRG stimulation more pleasant and less positional than conventional SCS. She reported pain relief of 80% and numerical rating scale (NRS) for her average pain was 2 out of 10. She stopped all medication except gabapentin. Her physical function improved dramatically and she could return to her parttime job. Psychological improvement was substantial, and 6-month follow up confirmed continuing improvements across all domains of her pain experience (Table 1).

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Table 1. Pain and psychological assessment of the patient, prior and after implantation of DRG stimulator, which shows significant improvement of pain intensity, anxiety, depression, catastrophizing and confidence in performing daily activities.

Scale

Pain - Numerical Rating Scale (0-no pain, 10 - worst pain) Pain relief (0%-no relief, 100% - complete relief) Patient Health Questionnaire – PHQ-9 Generalised Anxiety Disorder Assessment - GAD Catastrophizing scale - PCS Patient Self Efficacy Scale - PSEQ

Pre DRG stimulator implantation, after conventional SCS removal

3 months after DRG stimulator implantation

6 months after DRG stimulator implantation

9-10/10

2-3/10

2-3/10

10%

80-90%

80-90%

11/27

7/27

2/27

9/21

1/21

0/21

37/52 9/60

30/52 38/60

14/52 44/60

Discussion Mechanism of action The mechanism of action of conventional SCS and DRG is not fully understood. Analgesic effects of SCS appear related to activation of multiple inhibitory mechanisms: inhibition of hyperexcitable wide dynamic range (WDR) neurones, increased release of GABA in the dorsal horn, decreased concentration of glutamate, and activation of descending pathways.

In a recent review of mechanism of action of electrical stimulation on the dorsal root ganglion by Krames, it was suggested that DRG stimulation causes stabilisation of peripheral nociceptor sensitisation, release of neuromodulators in the dorsal horn of the spinal cord and deactivation of sensitized WDR neurons. It activates supraspinal centres, decreases hyperexcitability of DRG neurons by down-regulation of abnormal TTX-sensitive NA channels, up-regulation of K channels, and restitution of normal Ca current flow; it also stabilizes microglia within DRG1.

Anatomical consideration There are significant differences in anatomical and technical aspects of implantation of conventional SCS and DRG stimulators. The SCS lead is positioned in the epidural space at the specific level of the spinal cord, in the midline to stimulate appropriate dorsal column pathways. However, as the lead is not fixed in the epidural space it is prone to migration during the patient’s movement, causing changes to paraesthesia in topography and intensity.

Furthermore, there is acknowledged difficulty with providing coverage and effective analgesia to lower back, buttocks, feet, groin, pelvis and neck2.

The DRG lead is placed into the epidural space adjacent to the DRG in the intervertebral foramen. The electrode position is relatively fixed and provides dermatomal-specific 45 Journal of Observational Pain Medicine – Volume 1, Number 5 (2015) ISSN 2047-0800

stimulation-induced paresthesia. The limited amount of cerebrospinal fluid at the side of the electrode placement may limit the spread of electric current and improve targeted stimulation-related analgesia.

Evidence for treatment There have been several case series but few RCTs which showed that SCS seems to be effective therapy for CRPS. Taylor et al., in a systematic review based on one RCT, 25 case series and one cost-effectiveness study concerning mostly CRPS type I patients, concluded that SCS appears to be effective in managing CRPS type I (level A evidence) and type II (level D evidence)3. Kumar et al. presented a retrospective review of long-term (88 months) follow up for 25 CRPS patients. The author demonstrated significant improvement in the VAS pain score and other domains maintained over time. Moreover, he presented moderate to strong correlation of worsening outcomes if treatment was delayed over 12 months following the diagnosis4. Despite SCS being a useful treatment for early CRPS, there is no evidence of functional improvement in chronic CRPS type I. A limited number of studies regarding DRG stimulation and CRPS have been described. A recent study done by Van Buyten on the effectiveness of DRG for CRPS has shown that good results (greater than 50 % pain relief) were achieved by 6 out of 8 patients and the results were maintained at 12-month follow up 5. The responder rate is similar to or better than outcomes of conventional SCS for CRPS. The authors pointed out the lack of lead migrations during the observed time and very specific pain-paresthesia mapping in distal extremities.

Conventional SCS annual lead migration described in Guerts et al. long term study of CRPS patients was 7-13%6.

There is a very limited number of patients with CRPS type II included in any studies concerning neuromodulation or studies which directly compare conventional SCS and DRG stimulation. Unpublished and short term results of the ACCURATE study concerning conventional SCS vs. DRG stimulation, for failed back surgery syndrome, neuropathic limb pain and CRPS, showed the superiority of DRG stimulation in terms of greater pain reduction and better paraesthesia coverage.

Conclusions This case presents that DRG stimulation can be used with success for treatment of CRPS type II. DRG stimulation appeared to be superior to conventional SCS due to lack of positional changes of stimulation, better pain-paraesthesia coverage and reduced need for lead revision. Moreover, the patient's experience using DRG stimulation was better across all relevant domains. There is a need for more direct comparison studies as a definitive conclusion cannot be drawn from a single case.

Conflict of interest disclosures Disclaimers and conflict of interest policies are found at: http://bit.ly/1wqiOcl

Article submission and acceptance Date of Receipt: 14.09.2017

Date of Acceptance: 19.01.2017

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References: 1

Krames ES. The dorsal root ganglion in chronic pain and as a target for neuromodulation: A Review. Neuromodulation. 2015; 18: 24–32. PubMed: 25354206 2 Stuart RM, Winfree CJ. Neurostimulation techniques for painful peripheral nerve disorders. Neurosurg Clin N Am. 2009; 20(1):111-20. PubMed: 19064184 3 Taylor RS, Van Buyten JP, Buchser E. Spinal cord stimulation for complex regional pain syndrome: a systematic review of the clinical and cost-effectiveness literature and assessment of prognostic factors. Eur J Pain. 2006; 10(2):91-101.

PubMed:16310712 4 Kumar K, Rizvi S, Bnurs SB. Spinal cord stimulation is effective in management of complex regional pain syndrome I: fact or fiction. Neurosurgery. 2011; 69(3):566-78. PubMed: 21441839 5 Van Buyten JP, Smet I, Liem L, Russo M, Huygen F. Stimulation of Dorsal Root Ganglia for the management of Complex Regional Pain Syndrome: A prospective case series. Pain Practice. 2015; 15(3):208–216. PubMed:24451048 6

Geurts JW, Smits H, Kemler MA, Brunner F, Kessels AG, van Kleef M. Spinal cord stimulation for Complex Regional Pain Syndrome Type I: A prospective cohort study with long-term follow-up. Neuromodulation. 2013; 16:523–529.

PubMed:23363081

Contacts/correspondence For example: Tomasz Bendinger MD PhD FRCA FFPMRCA EDRA, Consultant in Anaesthesia and Pain Medicine. Address: Northern General Hospital, Anaesthetic and Pain Medicine Department, Herries Road, Sheffield,, S5 7AU, UK tel: 0114 2714195 fax: 0114 2269342 email: tombendinger@gmail.com

Intellectual property & copyright statement We as the authors of this article retain intellectual property right on the content of this article. We as the authors of this article assert and retain legal responsibility for this article. We fully absolve the editors and company of JoOPM of any legal responsibility from the publication of our article on their website. Copyright 2017. This is an open-access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution and reproduction in any medium, provided the original work is properly cited.

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Salvaging Function in the Traumatically Injured Limb

by Trans-Tibial Amputation Professor Michael Saleh, MBChB, MSc, FRCS, FRCS Ed. Professor of Orthopaedic Surgery, University of Sheffield

Abstract Trans-tibial amputation combined with recent prosthetic innovations provides a very effective way of salvaging function after severe lower limb injury. This surgeon advocates raising awareness of its potential, early involvement of specialist clinicians and a proactive reconstructive approach to the amputation itself alongside positive patient support and seamless rehabilitation is advocated. Amputation may not be the end of the process since prosthetic modifications, revision amputation surgery and late reconstruction of other limb deformities all play a role in improving overall function.

Introduction Most of what follows is the result of experience and observation rather than proven scientific fact. Nevertheless, such observations are valid and serve as a useful platform for debate.

In such an emotive situation, a pragmatic objective approach to treatment must additionally consider the wishes and mental state of the patient as well as the already established relationship with the emergency treating team. This paper serves to highlight potential deficiencies within the current system and ways of overcoming them. It emphasises the independent objective role of the rehabilitation physician/amputation surgeon and raises the question of whether such a person should be involved from the outset in severe limb injury cases.

The author would like to distinguish the amputation technique used in elective orthopaedics from that which is more commonly performed for vascular disease. The latter involves an older population with an ischaemic limb where a longer stump and reconstructive repair might contribute to further ischaemia and so both are generally contra-indicated. In the trauma situation, it may be possible to use reconstructive techniques from the outset if the zone of injury is distal to the planned flaps, but more commonly damaged tissues form part of the residuum, limiting the acute reconstructive possibilities.

Burgess and Romano in 1969 (1) promoted the long posterior flap operation, which permitted more dysvascular limbs to be salvaged at the trans-tibial (below-knee) level. The basic element was a very vascular posterior myocutaneous flap, which could be brought over the end of the stump and, in the more critical ischaemic cases, a short 12.5cm stump length as measured from the knee joint line was recommended.

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Some of my orthopaedic training was in Dundee under the stewardship of Professor George Murdoch. He had developed an internationally renowned limb fitting service run by orthopaedic surgeons, with a seamless continuity between the surgery, inpatient and out-patient rehabilitation facilities. I undertook academic research on prosthetic alignment using gait analysis on trans-tibial amputees (2) and performed many amputations under the guidance of Professor Murdoch and Mr Mike Turner. I then moved to Sheffield and, as Professor of Orthopaedics, developed a limb reconstruction service, often salvaging severe limb injury. At the same time, I took over a regional amputation-prosthetic service, which was jointly run initially by Dr Haresh Nirula and then Dr Dipak Datta. As a result, I have 35 years of continuous experience of dealing with amputees and a curious appetite to understand the dividing line between preservation and ablation. In such an emotive area one soon becomes aware of the importance of the patient’s feelings within this process.

Methods Reconstructive amputation: In 1993 I wrote a chapter on reconstructive amputation in a book called “Techniques in Orthopaedic Surgery” edited by David Evans (3). This helped to formulate my views and I concluded that a good trans-tibial amputation depended on: a long bony residuum a strong healthy knee horizontal bone ends careful resection of nerves a myodesis where the muscles are stitched into the bone a myoplasty where the muscles cover the end of the bone good quality sensate skin and skew flaps.

A longer stump will produce a more powerful lever but, if it is too long, it will limit the choice of prosthetic components that may be fitted between the end of the residuum and the ground. In an adult, it is quite possible to achieve a 14.5 to 17.5cm length stump, depending on the segment length. The most important length determining factor is the muscle available to wrap around the bone and create a myoplasty. As a rule of thumb, the musculotendinous junction of the calf is a useful guide to both the usable muscle and the length of the necessary skin flaps. There is a paucity of muscle below this level. In any event, it is vital to consult a rehabilitation physician or prosthetist regarding the patient’s potential prosthetic requirements and the space available to accept modern prosthetic components. The length of the residuum as a whole is determined not just by the bone section but the size of the tissue pad (amount of muscle and soft tissue) below this. This is important since some modern and complex prosthetic components for activities such as cycling need quite a lot of space.

We have moved away from Burgess’s long posterior flap towards the use of skew flaps initially described by Robinson and again promoted for vascular disease patients.

Since the sagittal diameter of the limb is smaller than the coronal diameter the flaps need not be quite as long to achieve closure. The flaps are therefore in the sagittal rather than in the coronal plane but skewed slightly laterally anteriorly and medially 49

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posterior, to avoid having a scar line over the sensitive tibial crest. In addition, since repair is side to side, there is less of a tendency to posterior subluxation of the distal skin and soft tissue pad.

Figure 1 Long Posterior Flap Procedure promoted by Burgess et al. (1971).

Skew Flap Myoplastic Procedure Robinson et al. (1982) reference 4.

Another worthy consideration but not identified in the chapter is the need for meticulous haemostasis. This surgeon, when he has reviewed cases of his own and others, has seen the frequency by which a good amputation result is complicated by haematoma, wound dehiscence and infection. It is therefore obligatory to use a 50

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careful haemostatic technique with diathermy, adrenaline packs and prolonged applied pressure until as much seepage as possible has been controlled. Finally, rather than use drains, this surgeon controls the wound environment within a padded plaster creating some mild, even external compression.

In this way, the skin wound will be healed in approximately two weeks, but the deeper tissues will take a further 3-4 weeks to mature sufficiently for a prosthetic limb to be used. Since the manufacture of the prosthetic socket takes time, casting may be performed about the 4-5-week stage. Distal swelling is inevitable and the use of an initial cast for two weeks, followed by shrinker socks and early walking aids, all help to reduce the swelling in time for prosthetic casting and fitting. These early walking aids support the residuum axially, preventing shear and damage to the healing tissues. In this ideal scenario, the amputee may well be capable of walking reasonably competently in two to three months and managing stairs, slopes etc by three to four months and eventually engaging in sport.

Figure 2 Amputation residuum at 2 weeks

Cycling at 6 months

Why arenâ&#x20AC;&#x2122;t all traumatic amputations like this? A qualitative review of over 150 patients seen for medico-legal reports has resulted in the observations that follow.

The emergency trauma amputation scene: The timelines described above are only achievable when operating within healthy tissues, such as acute foot and ankle trauma or late presentation of more proximal 51

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injuries with a degree of tissue recovery.

Following acute injury such as that caused by a motorcycle accident, there is global tissue injury; joints, bones, nerves, arteries and vessels, muscle, skin and soft tissue.

Of these it is severe and irreversible damage to joints, nerves and arterial injuries which most often dictates the need for early or immediate amputation. The patient will usually be evaluated by an orthopaedic surgeon, a plastic surgeon and possibly also a vascular surgeon. Surgeons are trained to use their skills to save the limb. The patient and relatives want to save the limb. The forward momentum is towards reconstruction of the limb, and that is as it should be. The impacting force in a limb injury will cause maximum injury at the point of delivery with centrifugal radiating zones of lesser injury. This is known as the zone of injury. By way of illustration, in a moderately severe Pilon (distal tibial) fracture, the macroscopic zone of injury will often extend from the midfoot to the junction of the middle and lower thirds of the tibia. The microscopic zone of injury probably extends up to the middle of the tibia.

If an amputation is considered, the ideal bony section will be in the mid tibia with sufficient skin, soft tissues and muscle to cover the end of the bone, hence the necessity for extension into the microscopic zone of injury. The zone of injury may also be inadvertently extended by attempted salvage surgery including; fasciotomies, open reduction and internal fixation, local flaps, external fixation, micro-vascular exploration and distal flaps, possibly from the contra-lateral limb or shoulder regions.

Naturally a lot of these reconstructive procedures will be successful, but in a more borderline case with limited success or outright failure one might argue towards amputation at an earlier stage. In such a case, it is important for the trauma team to visualise the requirements for a good amputation, to think carefully before extending the zone of injury with further salvage surgery or creating donor site morbidity, which will delay rehabilitation. This may not be so easy for the established team. One therefore wonders whether in some capacity the rehabilitation physician or amputation surgeon should be invited into this scenario to contribute at an early stage. He/she does not have the same vested interest in salvage and will offer a degree of objectivity that would be more difficult for the reconstructive team to employ.

Saving the knee joint will encourage a better and more efficient gait pattern than that seen with trans-femoral (above-knee) amputation. In some cases, where the zone of injury extends towards the knee, it may still be possible to achieve a good functional amputation level with a short (minimum 6cm) below-knee stump. This may involve retaining damaged tissues and working to reconstruct them. Function will certainly be better than that of a trans-femoral amputation, provided good soft tissue cover is achieved. Split skin grafted areas have the capacity to adapt, thicken and mature for efficient prosthetic use (figure 3). At the other end of the scale, where there is significant soft tissue injury extending from the knee down to the ankle, rather than performing a trans-tibial amputation it may be sensible to consider a Symeâ&#x20AC;&#x2122;s amputation, where the majority of the load transferred to the prosthetic socket is taken through the end of the stump, sparing additional pressure on the damaged circumferential tissues of the leg (figure 4).

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Figure 3 A short below-knee residuum covered with maturing split skin graft.

Figure 4 Severe extensive soft tissue injury appropriately treated by amputation through the ankle with the heel pad providing tissue cover (Symeâ&#x20AC;&#x2122;s).

Successful rehabilitation of an amputee requires a positive approach towards amputation, an early rehabilitation process -not delayed by transfer of service from one unit to another - and positive support for the mental state of the patient.

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Post-amputation assessment of the residuum: In a medico-legal scenario it is important to assess the competence of the residual limb in order to determine its durability, the need for revision and the potential to maximise/optimise function. In this respect a clinical/radiological assessment should consider; the knee joint, the bone ends, the nerves, the muscle, the skin and soft tissues.

The knee The knee should have smooth movement with a minimum of 0-90Âş and good power.

A myodesis will improve power (vide infra).

Figure 5 Knee flexion/extension

The bone The bone length should be as long as possible, since a longer lever will provide better control of the prosthesis. X-rays of the stump are not always taken but are important to exclude exostoses, an abnormal bevel and irregularities of the bone end, which will cause pressure sensitive areas on the stump. The bone end should be horizontalised in the coronal and the sagittal plane. The fibula should be shorter than the tibia by at least 2cm.

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Figure 6 Horizontal bone ends, note drill holes for myodesis.

The nerves A tender area between the tibia and fibula distally with sensitivity and tingling electric shocks may represent a common peroneal neuroma, which can be incapacitating. Imaging may be used to confirm the diagnosis and guide treatment (5).

The muscles Muscle bulk should be preserved with power being optimised by fixing the muscles directly into the bone (myodesis) and good soft tissue padding by bringing muscle over the end of the stump (myoplasty).

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Figure 7 A myodesis/myoplasty closure over the end of the bone.

The skin and soft tissues It is important to have as much good quality sensate skin covering the residuum as possible (6). This will provide valuable sensory feedback, both of the condition of the stumpâ&#x20AC;&#x2122;s soft tissues and also on the position (kinematics) of the limb. Having said that, some skin grafted areas perform well once they are mature. Sores and blistering may represent bony high points, insensate areas or prosthetic fitting issues.

Redundancy and laxity of the tissues will cause suboptimal prosthetic fit and lead to poor prosthetic control. The patient needs to be educated as to how to look after the stump: if there are irregularities or cavities in the skin these can lead to sweating and maceration.

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Figure 8 Redundant soft tissue seen at the end of the stump.

In a retrospective review of 27 trans-tibial amputations performed for trauma, where each one of the above categories - knee joint, bone, nerve, muscle, skin - scored 1 to 3 (with 1 being good, 3 being poor), there were four good cases - score 5, seventeen average cases - score 6 to 10 and six bad cases - score 11 to 15. Whilst some of these poor results reflect the severe extensive nature of the injury, in other cases one wonders whether earlier amputation or bringing in amputation surgery expertise at an earlier stage might have led to a better end result.

The author acknowledges that whilst such an approach to assessment will have a degree of internal consistency, without validation it would not have any transferable comparative value.

Revision residuum surgery: Another medico-legal question is the need for further surgery. Revision surgery may be performed because the residuum is failing, or because the residuum is not optimised and the patient is not achieving his full potential. Revision at the same level depends on the tissues available, revision to a higher level may be precipitated by stump failure, infection or arthritis. A semi-quantitative approach, such as the one this author uses, may be used to evaluate the residuum and consider the potential for 57

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optimisation with further surgery or prosthetic improvement.

Other adjunctive surgery: Amputation is performed because of a severely injured limb segment, but very often these patients have other segment and limb injuries such as ipsilateral femoral fracture There may be a tendency to overlook slight deformities in the light of a major limb loss. However, the benefits of realignment are even more acutely felt in the amputee since he/she has fewer alternative physical coping strategies. Dealing with these injuries may improve performance and reduce the strain on the residuum. In this scenario, the standard tools of the knee surgeon and limb reconstruction specialist are formative.

Figure 9 Derotation of ipsilateral femoral malunion.

The mental and physical welfare of the patient: It is important to provide a positive approach for the potential amputee client. Pain, prolonged hospitalisation and disappointment lead to deconditioning and a poor mental outlook. The treating team probably also feel this disappointment, and this may be transmitted to the patient. If at an early stage following trauma it appears that the limb might not be salvageable, it is important for the patient to understand how good function can be as an amputee and how far prosthetic components have developed. In someone who has experienced a lot of pain, it is important to have pain specialists and psychologists on board. The patient should undergo a medication review and receive advice on coping strategies. Personally, whether it has been proved scientifically or not, I feel there are major physical and psychological benefits for the patient to know that the entire peri-operative period will be managed by a single team with the use of local anaesthetics, epidurals and indwelling nerve catheters, and that post-operative pain will be sequentially managed and downscaled. A primarily healed amputation stump, and a treatment pathway that follows accurately the predicted pathway described pre-operatively, will all help the patient to regain trust and confidence in the process. There should be no hiatus following surgery, but a steady push to use and exercise the residuum and an agreed date for 58

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prosthetic fitting. It is crucial for the new amputee to see other established amputees, to begin walking as early as possible and to have a readily available support network.

Conclusion The mental and physical well-being of the trauma amputee would benefit from early intervention by a multidisciplinary prosthetic rehabilitation team with a milestonerelated package of care and support.

Whilst some of these comments may be contentious they are presented for consideration, to stimulate debate and increase awareness. For the purpose of this article they are, necessarily biased in favour of the amputation, yet this may not always be the appropriate process.

Conflict of interest disclosures Disclaimers and conflict of interest policies are found at: http://bit.ly/1wqiOcl

Article submission and acceptance Date of Receipt: 27.8.2016

Date of Acceptance: 30.1.2016

References 1.Burgess EM, Romano RL, Zettl JH, and Schrock RD. (1971). Amputations of the leg for peripheral vascular 2.insufficiency. Journal of Bone & Joint Surgery 53A, 874-90.

Saleh M, Murdoch G. (1985) In defence of gait analysis: Observation and measurement in gait assessment. Journal of Bone and Joint Surgery, 1985;67-B: 237-241.

3.Saleh M. Chapter 23 in Techniques in Orthopaedic Surgery; Edited by David Evans. 1993 Blackwell Scientific Publications.

4.Robinson KP, Hoile R, and Coddington T. (1982). Skew flap myoplastic below-knee amputation: a preliminary report. British Journal of Surgery 69, 554-7.

5.Thomas A, Bull MJ, Howard AC, Saleh M. Peri-operative Ultrasound Guided Needle Localisation of Amputation Stump Neuroma, Injury 30: 689-90,1999 6. Saleh M, Datta D, Waring S. The long posteromedial myocutaneous flap below knee amputation. Annals of the Royal College of Surgeons of England 77: 141-144

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Contacts/correspondence Professor Michael Saleh, Bridge Farm, Thurgarton, Norwich NR11 7HR info@msaleh.co.uk

Intellectual property & copyright statement I as the author of this article retain intellectual property rights on the content of this article. I as the author of this article assert and retain legal responsibility for this article. I fully absolve the editors and company of JoOPM of any legal responsibility from the publication of my article on their website. Copyright 2015. This is an open-access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution and reproduction in any medium, provided the original work is properly cited.

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