Decompression Therapy for the Treatment of …

Technology Assessment Program

Decompression Therapy for the Treatment of Lumbosacral Pain

Agency for Healthcare Research and Quality

540 Gaither Road Rockville, Maryland 20850

April 26 , 20 0 7

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

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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

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