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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 – PowerPoint PPT presentation

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


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 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

5
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

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
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
17
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
18
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
19
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
20
Mr Chambers enters a period of self-acceptance
21
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
22
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
23
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
24
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
25
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
26
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
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, 630pm-800pm
  • 8 week course
  • Call 503.230.2501 for course details
  • gregesmer_at_yahoo.com

29
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

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, 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

31
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

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, 57301-309
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