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

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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

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Disclosures

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

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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

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Mindfulness Based Stress Reduction for Failed
Back Surgery SyndromeA 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

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Mindfulness Based Stress Reduction for Failed
Back Surgery SyndromeA Randomized Clinical Trial

• Journal of the American Osteopathic Association
  2010110(11)646-652
• Funded by University of New England College of
  Osteopathic Medicine and the Osteopathic Heritage
  Fund

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Mindfulness?
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Mindfulness

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

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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

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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

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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

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2 Tiered Trial Design

• 12 week Randomized Clinical Trial
• MBSR Intervention arm
• Waitlist/Control arm
• 40 week Observational
• No Control group

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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.

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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

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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

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MBSR and FBSS

• 15/19 (79) completed the MBSR course
• 10/21 (48) completed the Waitlist Control

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Roland Morris Disability Questionnaire
Control 12 week n10 MBSR 12 week n15 P value 12 week Control v MBSR MBSR 40 week n15 Range
-0.1 (1.9) -3.6 (3.4) lt0.005 -3.4 (3.5) 0-24 scale
Standard deviation in parentheses
0high function, 24low function
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RMDQ / function

• Differences from Baseline at 12 and 40 weeks
• 0-24 point scale
• 12 week plt0.005
• clinically and statistically significant

0high function 24low function
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Chronic Pain Acceptance Questionnaire
Control 12 week n10 MBSR 12 week n15 P value 12 week Control v MBSR MBSR 40 week n15 Range
-6.7 (11.0) 7.0 (13.5) lt0.014 9.0 (8.4) 0-108 scale
Standard deviation in parentheses
0low pain acceptance, 108high pain acceptance
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CPAQ / quality of life

• Differences from Baseline at 12 and 40 weeks
• 0-108 point scale
• 12 week plt0.014
• clinically and statistically significant

0low pain acceptance 18high pain acceptance
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Mr Chambers enters a period of self-acceptance
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Abridged Pittsburgh Sleep Quality Index
Control 12 week n10 MBSR 12 week n15 p value 12 week Control v MBSR MBSR 40 week n15 Range
-0.2 (1.7) 2.0 (3.5) lt0.047 1.9 (3.3) 0-5 scale
Standard deviation in parentheses
0low sleep quality, 5high sleep quality
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Abridged PSQI / Sleep

• Differences from Baseline at 12 and 40 weeks
• 0-5 point scale
• 12 week plt0.047
• clinically and statistically significant

0poor sleep quality 4good sleep quality
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Analgesic Medication Log
Control 12 week n10 MBSR 12 week n15 P value 12 week Control v MBSR MBSR 40 week Range
0.4 (1.1) -1.5 (1.8) lt0.001 No results 0-4 scale
Standard deviations in parentheses
0no analgesics, 2daily non-narcotic analgesics,
4daily narcotic analgesics
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Analgesic Medication Log

• Differences from Baseline at 12 weeks
• 0-4 point scale
• 12 week plt0.001
• clinically and statistically significant

0no analgesics, 2 daily non-narcotic
analgesics, 4 daily narcotics
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Summary Visual Analog Scale for Pain
Control 12 week n10 MBSR 12 week n15 P value 12 week Control v MBSR MBSR 40 week n15 Range
-0.2 (6.0) -6.9 (6.9) lt0.021 -6.1 (8.3) 0-30 scale
Standard deviation in parentheses
0no pain, 30worst pain imaginable
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Summary VAS for Pain

• Differences from Baseline at 12 and 40 weeks
• 0-30 point scale
• 12 week plt0.021
• clinically and statistically significant

0no pain, 30 worst pain imaginable
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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

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MBSR in PDX

• Courses are taught Dr. Esmer at Osteopathic
  Advantage in Johns Landing
• Next course begins on April 27
• Wednesday nights, 630pm-800pm
• 8 week course
• Call 503.230.2501 for course details
• gregesmer_at_yahoo.com

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Bibliography

• Kabat-Zinn J, et al FourYear Follow-Up of a
  Meditation Based Program for the Self_Regulation
  of Chronic Pain Treatment Outcomes and
  Compliance. The Clinical Journal of Pain 1987,
  2159-173
• Kabat-Zinn J, et al The Clinical Use of
  Mindfulness Meditation for the Self-Regulation of
  Chronic Pain. Journal of Behavioral Medicine
  1985,8163-190

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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, 9103-112
• 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 2005,20136-138

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Bibliography

• Ragab A, Deshazo RD. Management of back pain in
  patients with previous back surgery. The
  American Journal of Medicine 2008123272-278.
• Roland M, Fairbank J The Roland-Morris
  Disability Questionnaire and the Oswestry
  Disability Questionnaire. Spine 2000,
  253115-3124

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