1. Mindfulness-Based Stress Reduction for Failed Back Surgery Syndrome: A Randomized Clinical Trial SPARC Mind-Body Medicine Greg Esmer DO Staff Physician Osteopathic Advantage 4/16/2011

2. Disclosures  I have no actual or potential conflict of interest in relation to this program/presentation.

3. Learning Objectives  Become familiar with the design and implementation of this trial  State whether this trial supports the treatment of Failed Back Surgery Syndrome with Mindfulness Based Stress Reduction

4. Mindfulness Based Stress Reduction for Failed Back Surgery Syndrome: A Randomized Clinical Trial  Investigators: Greg Esmer DO (co-PI), James Blum Ph.D (co-PI), Joanna Rulf OMS IV, and John Pier MD.  A Single-Center, Prospective, Randomized, Single-Blinded, Parallel- Group-Design Clinical Trial

5. Mindfulness Based Stress Reduction for Failed Back Surgery Syndrome: A Randomized Clinical Trial  Journal of the American Osteopathic Association 2010;110(11):646-652  Funded by University of New England College of Osteopathic Medicine and the Osteopathic Heritage Fund

6. Mindfulness?

7. Mindfulness  Awareness where thoughts, emotions, and physical sensations are accepted as is  Developed within several religious traditions over the past 2500 years

8. Mindfulness-Based Stress Reduction (MBSR)  A clinical education treatment approach for chronic illness  Mindfulness presented in a secular, healthcare context  Developed at UMass Medical Center  Over 600 MBSR Instructors worldwide  8 week course

9. Failed Back Surgery Syndrome (FBSS)  Back or leg pain that persists or recurs after one or more surgical procedure on the lumbosacral spine  Yearly incidence of FBSS is estimated to be between 25,000 and 80,000  Pain from FBSS is often debilitating and recalcitrant to treatment

10. Subject Procurement  Subjects with FBSS were recruited from a multidisciplinary spine center in Portland, Maine  220 study invitation letters sent  40 subjects were randomized  19 randomized MBSR  21 randomized to Waitlist Control  15 subjects analyzed in MBSR group  10 subjects analyzed in Waitlist Control

11. 2 Tiered Trial Design  12 week Randomized Clinical Trial  MBSR Intervention arm  Waitlist/Control arm  40 week Observational  No Control group

12. Intervention Reliability  Course Instructors completed the UMass Teacher Development Intensive  Professional experience in Healthcare, Education, or Social Change  Longstanding Meditation and Body Centered (Yoga) Practice  Completed a 10 day Silent, teacher led, Meditation Retreat  Course Instructors: Sue Young MA & Greg Esmer DO.

13. MBSR and FBSS Outcome Measures  Roland-Morris Disability Questionnaire (RMDQ)  Chronic Pain Acceptance Questionnaire (CPAQ)  Abridged Pittsburgh Sleep Quality Index (PSQI)  Analgesic Medication Log  Summary Visual Analog Scale (VAS) for Pain

14. MBSR and FBSS  Baseline Characteristics  No statistically significant differences in age, gender, height, weight, health status  No history of workers compensation  Relatively low RMDQ (~7) ie. high function for the FBSS population

15. MBSR and FBSS  15/19 (79%) completed the MBSR course  10/21 (48%) completed the Waitlist Control

16. Roland Morris Disability Questionnaire Control 12 week n=10 MBSR 12 week n=15 P value 12 week Control v MBSR MBSR 40 week n=15 Range -0.1 (1.9) -3.6 (3.4) <0.005-3.4 (3.5) 0-24 scale Standard deviation in parentheses 0=high function, 24=low function

17. RMDQ / function  Differences from Baseline at 12 and 40 weeks  0-24 point scale  12 week p<0.005  clinically and statistically significant 0=high function 24=low function

18. Chronic Pain Acceptance Questionnaire Control 12 week n=10 MBSR 12 week n=15 P value 12 week Control v MBSR MBSR 40 week n=15 Range -6.7 (11.0) 7.0 (13.5) <0.0149.0 (8.4) 0-108 scale Standard deviation in parentheses 0=low pain acceptance, 108=high pain acceptance

19. CPAQ / quality of life  Differences from Baseline at 12 and 40 weeks  0-108 point scale  12 week p<0.014  clinically and statistically significant 0=low pain acceptance 18=high pain acceptance

20. Mr Chambers enters a period of self-acceptance

21. Abridged Pittsburgh Sleep Quality Index Control 12 week n=10 MBSR 12 week n=15 p value 12 week Control v MBSR MBSR 40 week n=15 Range -0.2 (1.7) 2.0 (3.5) <0.0471.9 (3.3) 0-5 scale Standard deviation in parentheses 0=low sleep quality, 5=high sleep quality

22. Abridged PSQI / Sleep  Differences from Baseline at 12 and 40 weeks  0-5 point scale  12 week p<0.047  clinically and statistically significant 0=poor sleep quality 4=good sleep quality

23. Analgesic Medication Log Control 12 week n=10 MBSR 12 week n=15 P value 12 week Control v MBSR MBSR 40 week Range 0.4 (1.1) -1.5 (1.8) <0.001No results 0-4 scale Standard deviations in parentheses 0=no analgesics, 2=daily non-narcotic analgesics, 4=daily narcotic analgesics

24. Analgesic Medication Log  Differences from Baseline at 12 weeks  0-4 point scale  12 week p<0.001  clinically and statistically significant 0=no analgesics, 2= daily non-narcotic analgesics, 4= daily narcotics

25. Summary Visual Analog Scale for Pain Control 12 week n=10 MBSR 12 week n=15 P value 12 week Control v MBSR MBSR 40 week n=15 Range -0.2 (6.0) -6.9 (6.9) <0.021-6.1 (8.3) 0-30 scale Standard deviation in parentheses 0=no pain, 30=worst pain imaginable

26. Summary VAS for Pain  Differences from Baseline at 12 and 40 weeks  0-30 point scale  12 week p<0.021  clinically and statistically significant 0=no pain, 30= worst pain imaginable

27. Outcome Measures  Statistical and Clinical Significance achieved at 12 weeks for RMDQ, CPAQ, Abridged PSQI, Analgesic Log, and Summary VAS for Pain  Gains were maintained at 40 weeks for the uncontrolled portion of the study

28. MBSR in PDX  Courses are taught Dr. Esmer at Osteopathic Advantage in Johns Landing  Next course begins on April 27  Wednesday nights, 6:30pm-8:00pm  8 week course  Call 503.230.2501 for course details  gregesmer@yahoo.com

29. Bibliography  Kabat-Zinn J, et al: Four – Year Follow-Up of a Meditation – Based Program for the Self_Regulation of Chronic Pain: Treatment Outcomes and Compliance. The Clinical Journal of Pain 1987, 2:159-173  Kabat-Zinn J, et al: The Clinical Use of Mindfulness Meditation for the Self-Regulation of Chronic Pain. Journal of Behavioral Medicine 1985,8:163-190

30. Bibliography  Randolph P, et al: The Long-Term Combined Effects of Medical Treatment and a Mindfulness-Based Behavioral Program for the Multidisciplinary Management of Chronic Pain in West Texas. Pain Digest 1999, 9:103-112  Plews, Ogan M, et al: Brief Report: A Pilot Study Evaluating Mindfulness-Based Stress Reduction and Massage for the Management of Chronic Pain. J Gen Intern Med 2005,20:136- 138

31. Bibliography  Ragab A, Deshazo RD. Management of back pain in patients with previous back surgery. The American Journal of Medicine 2008;123:272-278.  Roland M, Fairbank J: The Roland- Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine 2000, 25:3115-3124

32. Bibliography  Kelly A: The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J 2001,18: 205-207  Buysse D, Reynolds C, Monk T, Berman S, Kupfer D: The Pittsburgh Sleep Quality Index: A New Instrument for Psychiatric Practice and Research. Psychiatry Research, 28: 193-213  Jenson M, et al: Relationship of Pain Beliefs to Chronic Pain Adjustment. Pain 1994, 57:301- 309