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Spinal manipulation, epidural injections, and self-care for sciatica: a pilot study for a randomized clinical trial |
Bronfort G, Evans RL, Maiers M, Anderson AV |
Journal of Manipulative and Physiological Therapeutics 2004 Oct;27(8):503-508 |
clinical trial |
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVE: To assess the feasibility of recruiting sciatica patients and to evaluate their compliance in preparation for a full-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.
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