Pain and CAM: What do the Guidelines Say

Pain and CAM: What Do The Guidelines Say? Robert A. Bonakdar, MD FAAFP

Disclosure • Research Support – Johnson and Johnson

• Consultant – Mcneil Consumer Health – Quadrant Healthcomm

Learning Objectives • Describe current definitions for CAM as well as prevalence and rationale for use • Review the inclusion of CAM in current guidelines for pain • Describe the approach to the patient when considering inclusion of CAM treatments

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Guideline Process Original Research

Consensus Opinion

Create Guidelines

Patient Input/preferen ce

Disseminate Guidelines

Support for dialogue / incorporation

Incorporate Guidelines into Practice?

Predicting practice change

Goal: Improve Patient Care / QoL

Do different guidelines improve care?

Definitions • CAM = Complementary & Alternative Med • IM = Integrative Medicine combines conventional care with EB CAM • Non-pharmacological (NP) options: – Complementary to medication and procedures – Behavioral options – Exercise / Activity – Physical Therapy National Center for Complementary and Alternative Medicine. (2007). What is Complementary and Alternative Medicine? Retrieved February 10, 2011, from http://nccam.nih.gov/health//whatiscam

NCCAM definition of CAM • Defining CAM is difficult, because the field is very broad and constantly changing. • NCCAM defines CAM as a group of diverse medical and health care systems, practices, and products that are not generally considered part of conventional medicine.

http://nccam.nih.gov/health/whatiscam

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Ex: NP treatments for Chronic Pain SAMHSA • Common nonpharmacological therapies for CNCP include: – Therapeutic exercise – Physical therapy (PT) – Cognitive–behavioral therapy (CBT)

• CAM; e.g., chiropractic therapy, massage therapy, acupuncture, mind–body therapies, relaxation strategies store.samhsa.gov/shin/content/SMA12-4671/SMA12-4671.pdf

Prevalence • ~ 27-60% of chronic pain patients use CAM • May be higher in certain pain populations:

Fleming, Rabago, Mundt, & Fleming, 2007 McEachrane-Gross, Liebschutz, & Berlowitz, 2006 Nayak, Matheis, Agostinelli, & Shifleft, 2001

• 81.5% tried > 1 of four CAM treatments Denneson LM, Corson K, Dobscha SK. Complementary and alternative medicine use among veterans with chronic noncancer pain. J Rehabil Res Dev. 2011;48(9): 1119-28.

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100 90

Ever Used Current Use

80 70 60 50 40 30

Health care providers (especially musculoskeletal specialists) should discuss these therapies with all arthritis patients.

20 10 0 Primary Care

Specialist

Callahan LF, Wiley-Exley EK, Mielenz TJ, Brady TJ, Xiao C, Currey SS, et al. Use of complementary and alternative medicine among patients with arthritis. Prev Chronic Dis 2009;6(2). http://www.cdc.gov/pcd/issues/2009/apr/08_0070.htm.

The US Headache Consortium Nonpharmacologic Tx well suited for those with: 1. Preference for such Tx 2. Poor tolerance for pharma Tx 3. Contraindications for specific pharma Tx 4. Insufficient or no response to pharma Tx 5. (planning to be) pregnant or nursing 6. H/O long-term, frequent, or excessive analgesic or acute medications 7. Exhibit significant stress or deficient stresscoping skills Campbell JK, Penzien DB, Wall EM. Evidence-based guidelines for migraine headache: behavioral and physical treatments.

US Headache Consortium 2000. Available at: http://www.aan.com.

Rationale for the Provider Common Themes: 4 P’s • • • •

Protect Promote Permit Partner – Shared decision making

Jonas, W.B., Chez, R.A. Complementary & alternative medicine. In Current Diagnosis & Treatment in Family Medicine.

South-Paul, JE, Matheny, SC and Lewis, EL (Eds). New York: McGraw-Hill 2007; pp.549-557.

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Holroyd KA, Cottrell CK, O'Donnell FJ, Cordingley GE, Drew JB, Carlson BW, Himawan L. Effect of preventive (beta blocker) treatment, behavioural migraine management, or their combination on outcomes of optimised acute treatment in frequent migraine: randomised controlled trial. BMJ. 2010 Sep 29;341:c4871.

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The Benefits of Biofeedback

From Nestoriuc Y, Martin A, RiefW, et al. Biofeedback treatment for headache disorders: a comprehensive efficacy review.

Applied Psychophysiol Biofeedback 2008;33:125–40

Permit • SAMHSA = Substance Abuse and Mental Health Services Administration; HHS – Managing Chronic Pain in Adults With or in Recovery from Substance Use Disorders

NP treatments for Chronic Pain Rationale: SAMHSA: • Pose no risk of relapse • May be more consistent with the recovering patient’s values and preferences than pharmacological treatments, especially opioid interventions.

• May reduce pain and improve quality of life in some patients who have CNCP • Should be included in most pain treatment plans. store.samhsa.gov/shin/content/SMA12-4671/SMA12-4671.pdf

Permit – VA Guidelines • Consider referral for alternative care modalities (Complementary Alternative Medicine) for patient symptoms, consistent with available resources and resonant with patient belief systems.

• Improves engagement in overall plan

http://www.ptsd.va.gov

How • Often Do We Partner ?

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Where to Access Guidelines?

• Pubmed: – http://www.ncbi.nlm.nih.gov/pubmed

• NCCAM Pain – http://nccam.nih.gov/health/providers/digest/c hronicpain.htm

• www.Mdguidelines.com • http://pain-topics.org • Society Websites

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http://nccam.nih.gov/health/providers/digest/chronicpain.htm

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http://nccam.nih.gov/health/providers/digest/chronicpain.htm

Guidelines Reviewed • SAMHSA = Substance Abuse and Mental Health Services Administration HHS – Managing Chronic Pain in Adults With or in Recovery from Substance Use Disorders

• Department of Veterans Affairs – Management of PTSD http://www.ptsd.va.gov

Guidelines Reviewed • Arthritis Guidelines – American College of Rheumatology – EULAR – NICE – OARSI

• Low Back Pain – ACP / APS: Low Back Pain

Guidelines Reviewed • Army Pain Management Task Force – Office of The Army Surgeon General – http://www.armymedicine.army.mil/reports/Pain_Mana gement_Task_Force.pdf

• American College of Occupational and Environmental Medicine (ACOEM) Practice Guidelines – http://www.acoem.org

• Institute for Clinical Systems Improvement – Assessment and Management of Chronic Pain 5th Edition/November 2011. www.icsi.org

Rating Scheme for the Strength of the Recommendations • Level A = Established as effective, ineffective, or harmful, – Or useful/predictive or not useful/predictive

• For the given condition in the specified population.

• (Level A rating requires at least two consistent Class I studies.)*

http://guidelines.gov

Rating Scheme for the Strength of the Recommendations • Level B = Probably effective, ineffective, or harmful • Level C = Possibly effective, ineffective, or harmful • (Level B/C requires at least one Class I study or 2 consistent Class II studies.)

• Level U = Data inadequate or conflicting

http://guidelines.gov

Strength of the Evidence • Class I: Prospective, RCT with masked outcome assessment, in a representative population. The following are required: a. Primary outcome(s) is/are clearly defined b. Exclusion/inclusion criteria are clear c. Adequate accounting for dropouts and crossovers with #s sufficiently low to have minimal potential for bias d. Relevant baseline characteristics are presented and substantially equivalent among treatment groups http://guidelines.gov

Strength of the Evidence • Class II: Prospective matched group cohort study in a representative population, with masked outcome assessment that meets a-d above OR a randomized controlled trial in a representative population that lacks one criterion a-d.

http://guidelines.gov

Strength of the Evidence • Class III: All other controlled trials including well-defined natural history controls or patients serving as own controls in a representative population, where outcome assessment is independently assessed or independently derived by objective outcome measurement.* http://guidelines.gov

Strength of the Evidence • Class IV: Evidence from uncontrolled studies, case series, case reports, or expert opinion. • *Objective outcome measurement: an outcome measure that is unlikely to be affected by an observer's (patient, treating physician, investigator) expectation or bias (e.g., blood tests, administrative outcome data) http://guidelines.gov

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http://www.rheumatology.org/practice/clinical/guidelines/osteoarthritis.asp

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http://www.rheumatology.org/practice/clinica l/guidelines/osteoarthritis.asp

• 25 Recommendations, including; – Exercise, PT, TENS – Topical Capsicum – Trial of Glucosamine/Chondroitin – Acupuncture may be of symptomatic benefit in patients with knee OA.

EULAR Knee OA Recommend.

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http://www.eular.org/

NICE Guidelines

www.nice.org.uk/CG059

A Review of the Guidelines

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Oxman AD, Guyatt GH. Validation of an index of the quality of review articles. J Clin Epidemiol 1991; 44(11):1271e8.

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Weakness of Guidelines • • • •

Do they agree with each other?

Does anybody listen?

Transition from passive to active care? VA Are they patient friendly? (ICSI & ACEOM)

– Inclusion of sliding scale for safety/efficacy – Does it encompass the complexity of the pain patient’s experience?

– Inclusion of patient input / education ACP/APS • Are they practitioner friendly? (ICSI) – Tools / Plans for incorporation

• Very low rate of NP recommendations: – Ex: 9% for exercise

• …most IM and ORTHO ignored the EULAR and OARSI recommendations…a majority of PCP and SMD adhered to the most of them • An effort for a better diffusion of these recommendations is justified…

Van Linthoudt D. Praxis (Bern 1994). 2009 Dec 2;98(24):1429-35.

Who Recommends What?

• Rheumatologists  >injections & NSAIDs • Orthopaedic surgeons  >surgery • PCP and rehab: NP (hydrotherapy), CAM and meds • Overall, such analyses suggest that the management of the patient with knee depends on the age, specialty, and country of origin of the practitioner.

So What Changes Habits?

• Distribution of recommendations have little influence of changing behavior • …interactive educational meetings are consistently effective at promoting behavioural changes among health professionals…

Bero LA, Grilli R, Grimshaw JM, Harvey E, Oxman AD, Thomson MA. Closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings. BMJ 1998;317:465–8.

IOM Report • A cultural transformation is necessary to better prevent, assess, treat, and understand pain of all types.

• healthcare providers should increasingly aim at tailoring pain care to each person’s experience and selfmanagement of pain should be promoted http://iom.edu/Reports/2011/%20Relieving-Pain-in-America-A-Blueprint-for-Transforming-Prevention-Care-EducationResearch/Report-Brief.aspx

• The Army Pain Management Task Force (PMTF) report called for a • “holistic, multidisciplinary, integrative approach to care.” http://www.armymedicine.army.mil/prr/pain_management.html

Army Pain Management Task Force •

Transition from Passive to Active •

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http://www.acoem.org

Recomm

American College of Occupational and Environmental Medicine's (ACOEM) Description of Categories

Strongly A Recomm end.

The intervention is strongly recommended improves health and functional outcomes

Mod. B Recomm end.

The intervention is recommended for appropriate patients.

Recomm C ended

The intervention is recommended for appropriate patients with limited evidence

Insuff. – I Recomm ended

The intervention is recommended for appropriate patients and has nominal costs & essentially no potential for harm. ..patients are best served by these practices, although the evidence is insufficient for an evidence-based recommendation.

Chronic Persistent Pain ACOEM Recommended

+/-

Not Recomm

Oral NSAIDs (B) TCAs (A) Lidocaine patches (I)

Topical NSAIDs (I) Duloxetine (I) Epidural clonidine (I) Other creams/ointments (I) Herbal: Menthe piperita Arnica Montana Curcuma longa, Tanacetum parthenium Zingiber officinalis (I) PT/OT (I) Infrared therapy (I) Ultrasound (I) Functional restoration (I)

Bed rest (I) Specific beds (I) Willow bark (salix) (I) Dextromethorphan (I) DMSO (I) Routine use of opioids (C) Hyperbaric oxygen (I) Magnets (I) H-wave stimulation (I) Steroids TPI (C) Botox /Epidural steroid neck pain (C)

Aerobic/strength exercise(A) Aquatic therapy (I) Yoga (I) Harpagoside (C) Capsicum creams (B) Acupuncture (C) Heat therapy (I) Manipulation neck pain (B) Massage (C) TENS for (C) Trigger point injections (C) CBT / Psych (C) Multidisciplinary rehab (I)

Acupuncture • Recommended as adjunctive first line for treatment of mod/severe: – Chronic moderate to severe neck pain – Chronic trigger points/myofascial pain – Chronic LBP – Osteoarthritis of the knee or hip

http://www.acoem.org

Indications • Prior treatments should include NSAIDs, exercise, and for trigger points, a trial of dry needling or injection(s) with bupivacaine.

• Additional considerations prior to treatment – anti-depressants – TENS.

• For osteoarthrosis, other Tx suggested: – walking program, weight loss, and NSAIDs

Frequency/Duration • A limited course as an adjunct to a conditioning program that has both graded aerobic exercise and strengthening exercises for treatment of neck or back pain, or trigger points/ myofascial pain • during which time there are clear objective and functional goals that are to be achieved.

Indications for Discontinuation • Resolution, intolerance, non-compliance, including non-compliance with aerobic and strengthening exercises.

• Strength of Evidence − Recommended • Acupuncture as 2nd/3rd line: – adhesive capsulitis, lateral epicondylitis or migraine headaches

Yoga • Indications - Chronic LBP patients who are motivated to try and adhere to a program of yoga.

• Indications for Discontinuation - Nontolerance, non-compliance • Strength of Evidence − Recommended • Also recommended as a treatment for other types of chronic persistent pain, provided patient is very motivated/comply acoem

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(ACOEM) Practice Guidelines http://www.acoem.org

• Doctors and patients should consider the following nondrug treatments for patients who do not respond to self-care: – Rehabilitation – Spinal manipulation – Exercise therapy – Massage – Acupuncture

– Yoga – Progressive relaxation – Cognitive-behavioral therapy

Annals of Internal Medicine 2 October 2007 (volume 147, pages 478-491, 492-504 , and505-514)

• ICSI conducted a focus group of patients who had received care for chronic pain.

The information gained from these discussions was summarized and presented to the work group as part of the guideline development process.

Objectives for conducting the chronic pain focus group • Learn the patient's perspective on living with chronic pain – Hear what patients do to manage their pain – Hear the patient's understanding of available options for treating pain – Determine how chronic pain influences changes in lifestyle and function – Understand the patient's perspective of the provider's role Assessment and Management of Chronic Pain Algorithm Annotations Fifth Edition/November 2011 Institute for Clinical Systems Improvement www.icsi.org

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http://www.icsi.org/guidelines_and_more/

Level I Treatments • Level I treatment encompasses – Pharmacologic management – Intervention management – Non-pharmacologic management – Complementary • Acupuncture • Herbal and Dietary Supplement • Healing Touch

Assessment and Management of Chronic Pain Algorithm Annotations Fifth Edition/November 2011 Institute for Clinical Systems Improvement www.icsi.org

• A plan of care for all patients with chronic pain should address all of the following five major elements: – Set personal goals – Improve sleep – Increase physical activity – Manage stress – Decrease pain http://www.icsi.org/guidelines_and_more/

Practical Considerations • All patients with chronic pain should participate in an exercise fitness program to improve function and fitness. • Self-management insures active patient participation in the care plan is essential.

http://www.icsi.org/guidelines_and_more/

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http://www.icsi.org/guidelines_and_more/

Objectives • Discuss current definitions for CAM as well as prevalence and rationale for use • Review the inclusion of CAM in current guidelines for pain and common comorbidities • Discuss approach to the patient when considering inclusion of CAM in treatment

Can we rapidly identify traditional, CAM users in the primary care encounter?

• “No easily observable characteristics were identified that clinicians might use to predict TM/CAM use in their patients.

• Rather than attempt to predict TM/CAM use… clinicians may be better served by assuming its use by all, by applying strategies for rapid and effective communications..”

Sussman AL, Williams RL, Shelley BM. Can we rapidly identify traditional, complementary and alternative medicine users in the primary care encounter? A RIOS Net study. Ethn Dis. 2010 Winter;20(1):64-70.

Can We Help Patients?

• Analysis of 256 PCP visits at UCSF • Despite differential knowledge about CAM treatments, physicians helped patients assess the risks and benefits of CAM treatments and made recommendations based on patient preferences • PRACTICE IMPLICATIONS: • Providers do not have to possess extensive knowledge about … CAM to have meaningful discussions with patients and to give patients a framework for evaluating CAM treatment Koenig CJ, Ho EY, Yadegar V, Tarn DM. Negotiating complementary and alternative medicine use in primary care visits with older patients. Patient Educ use.

Couns. 2012 Apr 5.

CAM Discussion • “…patients valued the support and guidance of 'trusted individuals' in making choices about CAM. • Trusted health professionals could also play a significant role in helping patients to make informed choices.

Evans M et al.. BMC Complement Altern Med. 2007 Aug 4;7:25.

Primary Care – CAM Discussion • “Such open communication could help to foster an environment of mutual trust where patients are encouraged to discuss their interest in CAM, rather than perpetuate covert, undisclosed use of CAM with its attendant potential hazards.”

Evans M et al.. BMC Complement Altern Med. 2007 Aug 4;7:25.

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store.samhsa.gov/shin/content/SMA12-4671/SMA12-4671.pdf

Guidance for Discussion Effective Yes S A F E

No

Y e Use/Recom Tolerate s mend N o

Monitor closely

• Clinicians can:

– Partner – Protect – Permit – Promote

Advise against • With patients about CAM practices as appropriate

Weiger et al, 2002, Annals Int Med Cohen M. Pediatrics, 2005 Chez RA, Jonas WB: The challenge of complementary and alternative medicine. Am J Obstet Gynecol 1997;177:1156.

• For back pain, osteoarthritis, and headache, there are few proven monotherapies.

• Acupuncture features a favorable safety profile and modest (most often for chronic back pain, osteoarthritis) to moderate (most often for headache) benefits on average.

J Clin Outcomes Manag. 2009 May 1; 16(5): 224–230.

Pragmatic Approach • A reasonable view of the current evidence would add acupuncture to the therapeutic armamentarium as an option, but not as the clear therapy of choice ..

• Acupuncture may be especially valuable for patients who prefer it to other options ..

• Acupuncture might also be useful as part of a multi-therapy package of care for some patients.

J Clin Outcomes Manag. 2009 May 1; 16(5): 224–230.

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http://nccam.nih.gov/health/decisions/practitioner.htm

Resources for Finding CAM Practitioners • Acupuncture American Association of Acupuncture and Oriental Medicine (AAAOM) http://www.aaaomonline.org • National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM) http://www.nccaom.org • Biofeedback Association for Applied Psychophysiology and Biofeedback – http://www.aapb.org  find practitioner

SAMSHA

Finding CAM Practitioners • Chiropractic American Chiropractic Association http://www.acatoday.org • Massage American Massage Therapy Association – http://www.amtamassage.org/findamassage/locator. aspx

Coordination • • • •

Therapeutic Trial (8-12 wks) Expectations from treatment?

Ask for status updates Monitoring – http://www.reliefinsite.com/ – www.iheadacheapp.com

• Follow-up for re-evaluation – to evaluate & decrease stockpiling treatments

• If helpful discuss longterm tapered approach to maintain benefit

Conclusions - CAM • CAM, in various forms, being used by a sizeable portion of pain patients • CAM should be part of the treatment discussion (4 P’s) • Several treatments helpful for patients in various pain scenarios • CAM use may help engagement of patients in overall treatment plan

Conclusions: Guidelines Original Research

Consensus Opinion

Create Guidelines

Patient Input/preferen ce

Disseminate Guidelines

Support for dialogue / incorporation

Incorporate Guidelines into Practice?

Predicting practice change

Goal: Improve Patient Care / QoL

Do different guidelines improve care?

Conclusions - Partnering • Set up realistic expectations for CAM Tx • Partner with patients to coordinate / optimize care: – Finding appropriate providers – Monitor progress: pain and QoL – Timing for re-evaluation – Shared decision-making

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http://www.icsi.org/guidelines_and_more/

General Case Discussion • Patient with symptomatic b/l knee OA comes to you asking for CAM suggestions: – Doc, I’ve heard acupuncture might help?

• Assuming conventional care: (NSAIDS / knee injections, PT) has been optimized, • Assuming lifestyle not optimized, • What do you / would you say to coordinate care?

Pain and CAM: What Do The Guidelines Say? Robert A. Bonakdar, MD FAAFP Director of Pain Management Scripps Center for Integrative Medicine

Assistant Clinical Professor University of California, San Diego, School of Medicine