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Mindfulness-Based Stress Reduction for Failed Back Surgery Syndrome: A Randomized Clinical Trial

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. Disclosures.

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Mindfulness-Based Stress Reduction for Failed Back Surgery Syndrome: A Randomized Clinical Trial

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  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. 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 Mindfulness Based Stress Reduction for Failed Back Surgery Syndrome:A Randomized 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 FBSSOutcome 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 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 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 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 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 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

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