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.