Decompression Therapy for the Treatment of Lumbosacral Pain
Decompression Therapy
for the Treatment of
Lumbosacral Pain
Technology
Assessment Program
Agency for Healthcare
Research and Quality
540 Gaither Road
Rockville, Maryland 20850
April 26, 2007
Decompression Therapy for the
Treatment of Lumbosacral Pain
Prepared by
ECRI Institute Evidence-based Practice Center
Marie Jurecki-Tiller, Ph.D.
Wendy Bruening, Ph.D.
Stephen Tregear, D.Phil.
Karen Schoelles, M.D., S.M.
Eileen Erinoff, B.A.
Vivian Coates, M.B.A.
Decompression Therapy for the
Treatment of Lumbosacral Pain
This report is based on research conducted by the ECRI Institute Evidence-based
Practice Center (EPC) under contract to the Agency for Healthcare Research and
Quality (AHRQ), Rockville, MD (Contract No. 290-02-0019). The findings and
conclusions in this document are those of the author(s) who are responsible for its
contents; the findings and conclusions do not necessarily represent the views of AHRQ.
Therefore, no statement in this report should be construed as an official position of the
Agency for Healthcare Research and Quality or of the U.S. Department of Health and
Human Services.
The information in this report is intended to help health care decision-makers; patients
and clinicians, health system leaders, and policymakers, make well-informed decisions
and thereby improve the quality of health care services. This report is not intended to be
a substitute for the application of clinical judgment. Decisions concerning the provision
of clinical care should consider this report in the same way as any medical reference
and in conjunction with all other pertinent information, i.e., in the context of available
resources and circumstances presented by individual patients.
This report may be used, in whole or in part, as the basis for development of clinical
practice guidelines and other quality enhancement tools, or as a basis for
reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human
Services endorsement of such derivative products may not be stated or implied.
Date: April 26, 2007
Prepared for:
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, Maryland 20850
Table of Contents
Tables........................................................................................................................................... iii
Figures ......................................................................................................................................... iv
EXECUTIVE SUMMARY .....................................................................................................................1
Key Questions ...................................................................................................................................... 1
Data Sources......................................................................................................................................... 2
Evidence Bases.................................................................................................................................... 3
Main Findings ....................................................................................................................................... 4
Conclusions .......................................................................................................................................... 7
SCOPE OF REPORT ..........................................................................................................................8
BACKGROUND ................................................................................................................................10
Lumbosacral Pain (Low back pain) .............................................................................................. 10
Decompression Therapy ................................................................................................................. 13
Competing/Complementary Technologies ................................................................................. 16
Clinical Practice Guidelines............................................................................................................ 17
Previous Systematic Reviews of Decompression Therapy ................................................... 17
Ongoing Clinical Trials..................................................................................................................... 18
Regulatory Issues.............................................................................................................................. 18
Training and Credentialing of Personnel to Use Decompression Therapy
Machinery ............................................................................................................................................ 20
CMS Coverage Policy ....................................................................................................................... 20
Third Party Payer Coverage............................................................................................................ 20
METHODS .......................................................................................................................................23
Key Questions Addressed .............................................................................................................. 23
Study Inclusion/Exclusion Criteria ............................................................................................... 25
Literature Searches........................................................................................................................... 27
Identification of Evidence Bases................................................................................................... 28
Evaluating the Strength of the Evidence..................................................................................... 31
Statistical Methods............................................................................................................................ 33
Characteristics of Included Studies ............................................................................................. 33
i
EVIDENCE SYNTHESIS ...................................................................................................................38
Key Question #1: What are the patient inclusion and exclusion criteria used in
studies of decompression therapy?............................................................................................. 38
Key Question #2: What are the efficacy or effectiveness outcomes measured in
studies of decompression therapy? Are the efficacy/effectiveness outcomes
measured in studies of decompression therapy comparable to those used in
studies of other non-surgical modalities for chronic low back pain due to a
herniated disc or degenerative disc disease?........................................................................... 40
Key Question #3: Is decompression therapy an effective treatment for chronic low
back pain due to herniated disc or degenerative disc disease? .......................................... 41
Key Question #4: What complications, harms, and adverse events associated
with decompression therapy have been reported?.................................................................. 47
Conclusions ........................................................................................................................................ 49
BIBLIOGRAPHY ...............................................................................................................................51
APPENDICES: SUPPORTING DOCUMENTATION AND EVIDENCE TABLES.................................54
Appendix A: Literature Search Methods ..................................................................................... 55
Appendix B: Excluded Studies ...................................................................................................... 60
Appendix C: Quality Assessment and Strength of Body of Evidence Rating
(Key Question 3) ................................................................................................................................ 61
Appendix D: Evidence Tables ........................................................................................................ 69
ii
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