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Original Research |

Spinal Manipulation and Home Exercise With Advice for Subacute and Chronic Back-Related Leg Pain: A Trial With Adaptive AllocationSpinal Manipulation and Home Exercise With Advice for Back-Related Leg Pain

Gert Bronfort, DC, PhD; Maria A. Hondras, DC, MPH; Craig A. Schulz, DC, MS; Roni L. Evans, DC, PhD; Cynthia R. Long, PhD; and Richard Grimm, MD, PhD
[+] Article, Author, and Disclosure Information

From University of Minnesota, Northwestern Health Sciences University, and Berman Center for Outcomes and Clinical Research at the Minneapolis Medical Research Foundation, Minneapolis, Minnesota, and Palmer Center for Chiropractic Research, Davenport, Iowa.

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, long_c@palmer.edu). 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, bronf003@umn.edu.

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.


Ann Intern Med. 2014;161(6):381-391. doi:10.7326/M14-0006
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Background: Back-related leg pain (BRLP) is often disabling and costly, and there is a paucity of research to guide its management.

Objective: 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.

Design: Controlled pragmatic trial with allocation by minimization conducted from 2007 to 2011. (ClinicalTrials.gov: NCT00494065)

Setting: 2 research centers (Minnesota and Iowa).

Patients: Persons aged 21 years or older with BRLP for least 4 weeks.

Intervention: 12 weeks of SMT plus HEA or HEA alone.

Measurements: 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.

Results: 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.

Limitation: Patients and providers could not be blinded.

Conclusion: 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.

Primary Funding Source: U.S. Department of Health and Human Services.

Figures

Grahic Jump Location
Figure 1.

Study flow diagram.

HEA = home exercise and advice; SMT = spinal manipulative therapy.

* Number of patients who did not provide primary outcome pain data at a particular time point and thereafter.

Grahic Jump Location
Grahic Jump Location
Figure 2.

Adjusted mean leg pain, disability, LBP, and global improvement scores with 95% CIs.

Estimates were computed by separate mixed-effects models using all observed data and adjusting for the variables used in the minimization algorithm. Leg pain and LBP scores are based on a scale of 0 (no pain) to 10 (worst pain possible). The disability scores are based on a scale of 24, and higher scores indicate more disability. Global improvement in leg pain or LBP was measured on a 9-point scale from 1 (no symptoms [100% improvement]) to 5 (no change [0% improvement]) to 9 (twice as bad [100% worse]). HEA = home exercise and advice; LBP = low back pain; SMT = spinal manipulative therapy.

Grahic Jump Location

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Summary for Patients

Treating Back-Related Leg Pain With Spinal Manipulation and Home Exercise

The full report is titled “Spinal Manipulation and Home Exercise With Advice for Subacute and Chronic Back-Related Leg Pain. A Trial With Adaptive Allocation.” It is in the 16 September 2014 issue of Annals of Internal Medicine (volume 161, pages 381-391). The authors are G. Bronfort, M.A. Hondras, C.A. Schulz, R.L. Evans, C.R. Long, and R. Grimm.

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