Spinal manipulation, epidural injections, and self-care for sciatica: A pilot study for a randomized clinical trial

Objective: To assess the feasibility of recruiting sciatica patients and to evaluate their compliance in preparation forfull-scale randomized clinical trial. We also aimed to determine the responsiveness of key outcome measures. Methods: Thirty-two subjects were randomly assigned to spinal manipulation (n = 11), epidural steroid injections (n = 11), or self-care education (n = 10). No between-group comparisons were planned because of the small sample size. Results: At week 12 (the end of the treatment phase), the outcome measures indicating the most improvement/change were the Oswestry disability score (mean, 22.9; SD, 19.9; effect size [ES], 1.8), leg pain severity (mean, 2.9; SD, 1.7; ES, 1.7), and if the symptoms were bothersome (mean, 25.2; SD, 16.0; ES, 1.6). Twenty-four patients were either,"very satisfied' or "completely satisfied," and 22 of 32 patients reported 75% or 100% improvement. After 52 weeks, the outcome measure showing the most improvement/change was leg pain severity (mean, 2.3; SD, 2.6; ES, 1.35), followed by the Oswestry disability score (mean, 15.6; SD, 20; ES, 1.2) and if symptoms were bothersome (mean, 18.1; SD, 22.6; ES, 1.1). Eighteen patients were either "very satisfied" or "completely satisfied," and 15 of 32 patients reported 75% or 100% improvement. Conclusions: The results of this pilot study suggest that it is feasible to recruit subacute and chronic sciatica patients and to obtain their compliance for a full-scale randomized clinical.