Spinal manipulation and home exercise with advice for subacute and chronic back-related leg pain

A trial with adaptive allocation

Gert Bronfort, Maria A. Hondras, Craig A. Schulz, Roni L. Evans, Cynthia R. Long, Richard Grimm

Research output: Contribution to journalArticle

26 Citations (Scopus)

Abstract

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.

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.

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.

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.

Background: Back-related leg pain (BRLP) is often disabling and costly, and there is a paucity of research to guide its management.

Original languageEnglish (US)
Pages (from-to)381-391
Number of pages11
JournalAnnals of Internal Medicine
Volume161
Issue number6
DOIs
StatePublished - Jan 1 2014

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Spinal Manipulation
Leg
Musculoskeletal Manipulations
Exercise
Pain
Pragmatic Clinical Trials
Low Back Pain
Research
Health Status

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Spinal manipulation and home exercise with advice for subacute and chronic back-related leg pain : A trial with adaptive allocation. / Bronfort, Gert; Hondras, Maria A.; Schulz, Craig A.; Evans, Roni L.; Long, Cynthia R.; Grimm, Richard.

In: Annals of Internal Medicine, Vol. 161, No. 6, 01.01.2014, p. 381-391.

Research output: Contribution to journalArticle

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abstract = "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.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.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.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.Background: Back-related leg pain (BRLP) is often disabling and costly, and there is a paucity of research to guide its management.",
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