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Chiropractic & Manual Therapies
Published in: Chiropractic & Manual Therapies 1/2011

Open Access 01-12-2011 | Study protocol

Chiropractic and self-care for back-related leg pain: design of a randomized clinical trial

Authors: Craig A Schulz, Maria A Hondras, Roni L Evans, Maruti R Gudavalli, Cynthia R Long, Edward F Owens, David G Wilder, Gert Bronfort

Published in: Chiropractic & Manual Therapies | Issue 1/2011

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Abstract

Background

Back-related leg pain (BRLP) is a common variation of low back pain (LBP), with lifetime prevalence estimates as high as 40%. Often disabling, BRLP accounts for greater work loss, recurrences, and higher costs than uncomplicated LBP and more often leads to surgery with a lifetime incidence of 10% for those with severe BRLP, compared to 1-2% for those with LBP.
In the US, half of those with back-related conditions seek CAM treatments, the most common of which is chiropractic care. While there is preliminary evidence suggesting chiropractic spinal manipulative therapy is beneficial for patients with BRLP, there is insufficient evidence currently available to assess the effectiveness of this care.

Methods/Design

This study is a two-site, prospective, parallel group, observer-blinded randomized clinical trial (RCT). A total of 192 study patients will be recruited from the Twin Cities, MN (n = 122) and Quad Cities area in Iowa and Illinois (n = 70) to the research clinics at WHCCS and PCCR, respectively.
It compares two interventions: chiropractic spinal manipulative therapy (SMT) plus home exercise program (HEP) to HEP alone (minimal intervention comparison) for patients with subacute or chronic back-related leg pain.

Discussion

Back-related leg pain (BRLP) is a costly and often disabling variation of the ubiquitous back pain conditions. As health care costs continue to climb, the search for effective treatments with few side-effects is critical. While SMT is the most commonly sought CAM treatment for LBP sufferers, there is only a small, albeit promising, body of research to support its use for patients with BRLP.
This study seeks to fill a critical gap in the LBP literature by performing the first full scale RCT assessing chiropractic SMT for patients with sub-acute or chronic BRLP using important patient-oriented and objective biomechanical outcome measures.

Trial Registration

ClinicalTrials.gov NCT00494065
Appendix
Available only for authorised users
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Metadata
Title
Chiropractic and self-care for back-related leg pain: design of a randomized clinical trial
Authors
Craig A Schulz
Maria A Hondras
Roni L Evans
Maruti R Gudavalli
Cynthia R Long
Edward F Owens
David G Wilder
Gert Bronfort
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Chiropractic & Manual Therapies / Issue 1/2011
Electronic ISSN: 2045-709X
DOI
https://doi.org/10.1186/2045-709X-19-8

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