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.
| Original language | English (US) |
|---|---|
| Article number | 8 |
| Journal | Chiropractic and Manual Therapies |
| Volume | 19 |
| DOIs | |
| State | Published - Mar 22 2011 |
Bibliographical note
Funding Information:This project is supported by funds from the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA), Bureau of Health Professions (BHPr), Division of Medicine and Dentistry (DMD) under grant number R18HP07638, Chiropractic and Self-Care For Back-Related Leg Pain. This information or content and conclusions are those of the author and should not be construed as the official position or policy of, nor should any endorsements be inferred by the U.S. government, HHS, HRSA, BHPr or the DMD. The authors wish to thank the research clinicians and staff participating in these trials and study collaborators for their input during the design phase.