Spinal Manipulation, Epidural Injections, and Self-Care for Sciatica: A Pilot Study for a Randomized Clinical Trial
Received 14 May 2003
Abstract
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.
aWolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, Bloomington, Minn.
bPain Assessment and Rehabilitation Center, Edina, Minn
Gert Bronfort, DC, PhD, Northwestern Health Sciences University, 2501 W 84th Street, Bloomington, MN 55431
This study was funded by the Foundation for Chiropractic Education and Research. Dr. Bronfort holds the Greenawalt Research Chair, funded through an unrestricted grant from Foot Levelers, Inc.
ABSTRACT