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
I have no actual or potential conflict
of interest in relation to this
program/presentation.
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
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, ParallelGroup-Design Clinical Trial
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
Mindfulness?
QuickTime™ and a
TIFF (Uncompressed) decompressor
are needed to see this picture.
Mindfulness
Awareness where thoughts, emotions,
and physical sensations are accepted
as is
Developed within several religious
traditions over the past 2500 years
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
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
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
2 Tiered Trial Design
12 week Randomized Clinical Trial
MBSR Intervention arm
Waitlist/Control arm
40 week Observational
No Control group
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.
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
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
MBSR and FBSS
15/19 (79%) completed the MBSR
course
10/21 (48%) completed the Waitlist
Control
Roland Morris Disability
Questionnaire
Control MBSR P value MBSR
12 week 12 week 12 week 40 week
n=10
n=15
Control
n=15
v MBSR
-0.1
-3.6
<0.005
-3.4
(1.9)
(3.4)
(3.5)
Standard deviation in parentheses
0=high function, 24=low function
Range
0-24
scale
RMDQ / function
0
-0.5
-1
-1.5
-2
Control
-2.5
MBSR
-3
-3.5
-4
12 Weeks 40 Weeks
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
Chronic Pain Acceptance
Questionnaire
Control MBSR P value MBSR
12 week 12 week 12 week 40 week
n=10
n=15
Control
n=15
v MBSR
-6.7
7.0
<0.014
9.0
(11.0)
(13.5)
(8.4)
Range
0-108
scale
Standard deviation in parentheses
0=low pain acceptance, 108=high pain acceptance
CPAQ / quality of life
10
8
6
4
2
0
-2
-4
-6
-8
Waitlist
Control
MBSR
12
week
40
week
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
Mr Chambers enters a period
of self-acceptance
Abridged Pittsburgh Sleep
Quality Index
Control MBSR p value MBSR
12 week 12 week 12 week 40 week
n=10
n=15
Control
n=15
v MBSR
-0.2
2.0
<0.047
1.9
(1.7)
(3.5)
(3.3)
Range
0-5
scale
Standard deviation in parentheses
0=low sleep quality, 5=high sleep quality
Abridged PSQI / Sleep
2
1.5
1
Waitlist
Control
0.5
MBSR
0
-0.5
12
week
40
week
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
Analgesic Medication Log
Control MBSR P value MBSR
12 week 12 week 12 week 40 week
n=10
n=15
Control
v MBSR
0.4
(1.1)
-1.5
(1.8)
<0.001
No
results
Range
0-4
scale
Standard deviations in parentheses
0=no analgesics, 2=daily non-narcotic analgesics,
4=daily narcotic analgesics
Analgesic Medication Log
0.5
0
-0.5
Watilist
Control
MBSR
-1
-1.5
0=no analgesics, 2= daily
non-narcotic analgesics,
4= daily narcotics
Differences from
Baseline at 12
weeks
0-4 point scale
12 week p<0.001
clinically and
statistically
significant
Summary Visual Analog Scale
for Pain
Control MBSR P value MBSR
12 week 12 week 12 week 40 week
n=10
n=15
Control
n=15
v MBSR
-0.2
-6.9
<0.021
-6.1
(6.0)
(6.9)
(8.3)
Range
0-30
scale
Standard deviation in parentheses
0=no pain, 30=worst pain imaginable
Summary VAS for Pain
0
-1
-2
-3
Waitlist
Control
-4
MBSR
-5
-6
-7
12
week
40
week
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
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
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
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
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 2005,20:136138
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 RolandMorris Disability Questionnaire and the
Oswestry Disability Questionnaire. Spine
2000, 25:3115-3124
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, 57:301309