Spinal manipulation and home exercise with advice for subacute and chronic back-related leg pain: a trial with adaptive allocation.

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.

RCT Entities:   Population Interventions Outcomes