Massage Therapy for Chronic Low Back Pain: Results and Future Steps

1. KYPROS: A Kan Study Methods, Results and Next Steps William G. Elder, PhD Niki Munk, PhD, LMT UK Family and Community Medicine IU School of Health and Rehabilitation Sciences MAY 9, 2014 Support: National Center for Complementary and Alternative Medicine (NCCAM) grant #R21AT004544 National Center for Advancing Translational Sciences. National Institutes of Health (NIH) grant #UL1 TR000117

2. KYPROS KentuckYPain Research Outcomes Studies

3. Kypros: Introduction First “real world” study to examine massage therapy (MT) and progressive muscle relaxation therapy (PMR) for patients with CLBP when referred in conjunction with usual care from PCPs. • Evaluate for improvements in health-related outcomes. • Demonstrate the feasibility of this type of study.

4. KYPROS Results Clinical massage therapy (CMT) delivered during a 12 week period resulted in significant statistical and clinical improvement of functional health related outcomes for chronic low back pain (CLBP) patients of primary care providers. Feasibility demonstrated with many lessons learned.

5. Presentation Objectives 1. Recognition and thanks 2. Discuss practice based research and study methodology • What makes practice based research unique? • What conclusions does it permit? 3. Describe study results for benefit of treatment of CLBP patients 4. Examine next steps of this research

6. Objective 1 - THANK YOU! • Community Faculty • Development of research question • Development of methodology • Maureen Flannery, MD • David Greene, MD • Primary Care Providers (PCPs) • 67 PCPs consented to participate in the study. • 10 were in rural areas • 48 PCPs returned at least one pocketcard in 18 sites that participated

7. KYPROS KAN Practices Thomas J. Burchett, MD Lexington Family Medicine Winchester Medical Associates Chevy Chase Primary Care Family Practice Associates Kentucky Clinic South Baptist Internal Medicine – Leestown Baptist Internal Medicine – Furlow and Associates Baptist Internal Medicine – Beaumont Center Midway Center for Integrative Medicine Winchester Family Practice Enlow and Shahzad UK Family Medical Center @ Kentucky Clinic Baptist Family Physicians at Tates Creek Baptist Family Physicians in Scott County Berea Primary Care Clinic White House Clinic - Richmond White House Clinic - Berea

9. Objective 2 Practice Based Research & KYPROS Methodology

10. KYPROS: Design: Two-armed, repeated measures, observational trial and feasibility study. “Real world study” AIM of REAL WORLD STUDIES: Do the interventions of interest work in practice?

11. What Factors Affect Treatment Choice? • Efficacy

12. Efficacy of cmt • Examined extensively • High quality Cochrane systematic review • Massage therapies are beneficial for CLBP. • Recommended more studies to assess impact on functioning and quality of life. •  Recent high quality RCT • Massage effects for CLBP last up to fifty-two weeks • Very strict exclusion criteria. Furlan AD, Imamura M, Dryden T, Irvin E. Massage for low-back pain. The Cochrane database of systematic reviews. 2008(4) Cherkin DC, Sherman KJ, Kahn J, Wellman R, Cook AJ, Johnson E, et al. A comparison of the effects of 2 types of massage and usual care on chronic low back pain: a randomized, controlled trial. Ann Inter Med. 2011;155(1):1-9.

13. What Factors Affect Treatment Choice? • Efficacy • Previous experience with the treatment • Local norms • Side and adverse effects • Condition severity • Comorbid conditions • Concurrent treatments • Continuity • Other patient characteristics • Patient expectations • Availability and costs All of these, plus research design issues, add up to an expectation that a treatment will work in practice

14. Level of EvidenceAmerican College of Physicians and American Spine Society Guidelines For nonspecific acute LBP advise patients to remain active and perform self-care; medication selection should consider the poor long-term efficacy and safety data for opioids, with acetaminophen and NSAIDs as first-line medication options. For patients not improving with self-care, the guidelines recommend addition of nonpharmacological approaches Chou, Quaseem, Snow, Cassey, Cross, Sheckle. Ann Int Med, 2007

15. Level of EvidenceAmerican College of Physicians and American Spine Society Guidelines For CLBP, Intensive interdisciplinary rehabilitation, exercise therapy, acupuncture, massage therapy, spinal manipulation, yoga, cognitive-behavioral therapy, or progressive muscle relaxation (PMR). However, the guideline authors and others expressed concern that the effectiveness of these approaches had not yet been evaluated in primary care settings and, thus placed this recommendation at a lower tier (weak recommendation, moderate evidence) in comparison, for example, to prescribing NSAIDS. Chou, Quaseem, Snow, Cassey, Cross, Sheckle. Ann Int Med, 2007

16. Level of EvidenceAmerican College of Physicians and American Spine Society Guidelines However, Guideline authors and others expressed concern that the effectiveness of these approaches had not yet been evaluated in primary care settings. Placed this recommendation at a lower tier (weak recommendation, moderate evidence) in comparison, for example, to prescribing NSAIDS. Chou, Quaseem, Snow, Cassey, Cross, Sheckle. Ann Int Med, 2007

17. Goal of Our Research and its methodology Examine CMT to see if merits higher level of evidence? Make new treatments available to offer CLBP patients.

18. Efficacy and Effectiveness • Efficacy • In controlled conditions, does a specific input result in a specific outcome? • Effectiveness • Does a treatment work in practice? • Effect • Both of these deal with effect. • That is, what is the effect of X on Y? • The question is where and under what conditions?

19. Intervention Development, Refinement and Standardization Staged Process for Developing Non-Pharmacological Interventions Collaboration or Partnership with “Real-World” Setting Studies to Demonstrate Clinically Meaningful Signal Dissemination & Implementation Studies Effectiveness or Comparative Effectiveness Research Pilot Feasibility Studies Intervention Efficacy Studies with Appropriate Comparison Iterative process Controlled Clinical Setting From W Weber; NCCAM, May 16, 2012

20. Explanatory vs. Pragmatic • Explanatory • What are the effects of an intervention under ideal circumstances? • Efficacy • Pragmatic • What are the effects of an intervention under usual circumstances where applied? • Effectiveness

21. Example of an explanatory trial “Among patients with angiographically-confirmed, symptomatic 70-99% stenosis of a carotid artery, can the addition of carotid endarterectomy (performed by an expert vascular or neurosurgeon with an excellent track record) to best medical therapy, vs. best medical therapy alone, reduce the risk of major or fatal stroke over the next two years of rigorous follow-up?” (NASCET:NEJM 1991;325:445-53) From: http://support-collaboration.org/precis.pdf

22. explanatory trial: Pros and Cons • Advantage If negative, you can abandon the treatment (it won’t work anywhere) • Disadvantage If positive, you still don’t know whether it will work in usual health care conditions From: http://support-collaboration.org/precis.pdf

23. Example of an Pragmatic trial Among women at 12-32 weeks gestation whose clinicians thought they were at sufficient risk for pre-eclampsia or IUGR to be uncertain whether they should be prescribed low-dose aspirin, does simply prescribing aspirin (compared with placebo), and with no study follow-up visits, reduce the risk of a composite of bad outcomes for her or her baby? (CLASP:Lancet 1994;343:619-29) From: http://support-collaboration.org/precis.pdf

24. Pragmatic Trial: Pros and Cons • Advantage If positive, it really works and you can implement the treatment just about everywhere. • Disadvantage If negative, you can’t distinguish a worthless treatment from an efficacious treatment that isn’t applied/accepted widely enough. From: http://support-collaboration.org/precis.pdf

25. PRECIS PR pragmatic (to) E explanatory C continuum I indicator S summary

26. Precis domains/components • Participant eligibility criteria • Intervention flexibility • Experimental intervention • Comparison intervention • Intervention practitioner expertise • Experimental intervention practitioner • Comparison intervention practitioner • Follow-up intensity • Primary trial outcome • Compliance/Adherence • Participant to intervention • Practitioner to study protocol • Analysis of the primary outcome

27. PRECIS spokes • Each spoke is defined in terms of restrictions on an otherwise totally pragmatic trial. • The more restrictive the trial, the lower its PRECIS score; the lower its PRECIS score, the smaller the population for generalizability. Informed by : http://support-collaboration.org/precis.pdf

29. Objective 2: Continued KYPROS Methodology Via PRECIS Context

30. KYPROS PRECIS

31. KYPROS PRECIS: MT Only

32. Objective 3 Describe study results for benefit of treatment of CLBP patients

33. Baseline Results Notes: *Percentages excluded due to redundancy (N=100). **Indicates statistical differences of >0.05. †Higher number indicates worse outcome. ‡Higher number indicates better outcome/higher expectation. ±Scores are normalized such that those above 50% are better than average and those below 50% are worse than average.

34. Post Intervention Results Univatiate Paired t-tests for Baseline and V2 Differences: N=85 Notes: †Decrease in scores desired. ‡Increase in scores desired. ±Scores are normalized such that those above 50% are better than average and those below 50% are worse than average. * p ≤ 0.01

35. Frequency of Meaningful Change

36. ODI: What does CLBP with Disability Looks Like… ODI = 40% Disability Personal care is normal but very painful. No sitting or standing > 1 hour. < 6 hours of sleep per night. Prevents any sex life at all. Normal social life but increases pain. Pain is bad when travels are > 2 hours.

37. ODI: What Clinical Benefit Looks Like… • Starting with 40% disability – 30pt change and 75% improvement • Normal but painful personal care to normal care with no pain. • No sitting for more than an hour to sit in any chair as long as I like. • No standing for more than an hour to standing as long as I like with no pain. • < 6 hours of sleep to my sleep is never disturbed by pain. • No sex life at all due to pain to normal sex life with no extra pain. • Normal but painful social life to normal, with no pain. • Limited travels to can travel anywhere with some extra pain. • Starting with 54% disability – 14pt change and 26% improvement • Pain intensity from severe to mild. • Only lifting light to medium weights to heavy weights if conveniently placed. • Only walking 100 yards to walking ¼ mile. • Severely restricted sex life to nearly normal but painful sex life. • No 1+ hour journeys to can travel anywhere with some extra pain.

38. Secondary Analysis:Age Differences

39. Informing Next Steps • Starting point:

40. Informing Next Steps Notes: * Frequency (%) for ODI scores of those who changed from ODI score of ≥ 12 at baseline to < 12 at TD2.

41. Informing Next Steps

42. Secondary Analysis: Starting Point Differences

43. Objective 4 Next Steps

44. Conclusions/Future Plans • Demonstrated effectiveness research feasibility. • Larger study with more patient participants – clarify effectiveness and begin cost assessment • Mental health w/ CLBP • CLBP patients on scheduled medications • Medical complexity and CLBP reflective of real world • R34/R01 Route: Feasibility (larger network/ patient complexity) - Implementation

45. Thank you! Questions? Acknowledgements: Maureen Flannery, MD David Green, MD Margaret Love, PhD Geza Bruckner, PhD Karen Roper, PhD Katie Stewart, BA, LMT Kevin Pearce, MD Contact: Bill Elder, PhD welder@uky.edu NIH/NCCAM Grant #1R21AT004544-01A2