Gert Bronfort, DC, PhD; Maria A. Hondras, DC, MPH; Craig A. Schulz, DC, MS; Roni L. Evans, DC, PhD; Cynthia R. Long, PhD; Richard Grimm, MD, PhD
Acknowledgment: The authors thank the coinvestigators at both sites for their collaboration to develop and analyze the biomechanical objective outcome measures and qualitative data, which will be reported elsewhere. The authors also thank the research patients, clinicians, therapists, and staff for the successful conduct of this trial.
Grant Support: By the Health Resources and Services Administration, U.S. Department of Health and Human Services (grant R18HP07638).
Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M14-0006.
Reproducible Research Statement:Study protocol: Available at http://chiromt.com/content/19/1/8. Statistical code: Available from Dr. Long (email, email@example.com). Data set: Not available.
Requests for Single Reprints: Gert Bronfort, DC, PhD, Center for Spirituality & Healing, University of Minnesota, MMC 505, 425 Delaware Street Southeast, Minneapolis, MN 55455; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Bronfort and Evans: Center for Spirituality & Healing, University of Minnesota, MMC 505, 425 Delaware Street Southeast, Minneapolis, MN 55455.
Drs. Hondras and Long: Palmer Center for Chiropractic Research, 741 Brady Street, Davenport, IA 52803-5209.
Dr. Schulz: Northwestern Health Sciences University, Wolfe-Harris Center for Clinical Studies, 2501 West 84th Street, Bloomington, MN 55431.
Dr. Grimm: Berman Center for Outcomes and Clinical Research at the Minneapolis Medical Research Foundation, 825 South 8th Street, Suite 440, Minneapolis, MN 55404.
Author Contributions: Conception and design: G. Bronfort, M.A. Hondras, C.A. Schulz, R.L. Evans, C.R. Long, R. Grimm.
Analysis and interpretation of the data: G. Bronfort, M.A. Hondras, C.A. Schulz, R.L. Evans, C.R. Long, R. Grimm.
Drafting of the article: G. Bronfort, M.A. Hondras, C.A. Schulz, R.L. Evans, C.R. Long.
Critical revision of the article for important intellectual content: G. Bronfort, M.A. Hondras, C.A. Schulz, R.L. Evans, C.R. Long, R. Grimm.
Final approval of the article: G. Bronfort, M.A. Hondras, C.A. Schulz, R.L. Evans, C.R. Long, R. Grimm.
Provision of study materials or patients: G. Bronfort, M.A. Hondras, C.A. Schulz.
Statistical expertise: C.R. Long, R. Grimm.
Obtaining of funding: G. Bronfort, M.A. Hondras, C.A. Schulz, R.L. Evans, C.R. Long.
Administrative, technical, or logistic support: G. Bronfort, M.A. Hondras, C.A. Schulz, R.L. Evans, C.R. Long.
Collection and assembly of data: G. Bronfort, M.A. Hondras, C.A. Schulz, R.L. Evans.
Bronfort G, Hondras MA, Schulz CA, Evans RL, Long CR, Grimm R. Spinal Manipulation and Home Exercise With Advice for Subacute and Chronic Back-Related Leg Pain: A Trial With Adaptive Allocation. Ann Intern Med. 2014;161:381-391. doi: 10.7326/M14-0006
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Published: Ann Intern Med. 2014;161(6):381-391.
Back-related leg pain (BRLP) is often disabling and costly, and there is a paucity of research to guide its management.
To determine whether spinal manipulative therapy (SMT) plus home exercise and advice (HEA) compared with HEA alone reduces leg pain in the short and long term in adults with BRLP.
Controlled pragmatic trial with allocation by minimization conducted from 2007 to 2011. (ClinicalTrials.gov: NCT00494065)
2 research centers (Minnesota and Iowa).
Persons aged 21 years or older with BRLP for least 4 weeks.
12 weeks of SMT plus HEA or HEA alone.
The primary outcome was patient-rated BRLP at 12 and 52 weeks. Secondary outcomes were self-reported low back pain, disability, global improvement, satisfaction, medication use, and general health status at 12 and 52 weeks. Blinded objective tests were done at 12 weeks.
Of the 192 enrolled patients, 191 (99%) provided follow-up data at 12 weeks and 179 (93%) at 52 weeks. For leg pain, SMT plus HEA had a clinically important advantage over HEA (difference, 10 percentage points [95% CI, 2 to 19]; P = 0.008) at 12 weeks but not at 52 weeks (difference, 7 percentage points [CI, −2 to 15]; P = 0.146). Nearly all secondary outcomes improved more with SMT plus HEA at 12 weeks, but only global improvement, satisfaction, and medication use had sustained improvements at 52 weeks. No serious treatment-related adverse events or deaths occurred.
Patients and providers could not be blinded.
For patients with BRLP, SMT plus HEA was more effective than HEA alone after 12 weeks, but the benefit was sustained only for some secondary outcomes at 52 weeks.
U.S. Department of Health and Human Services.
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