In 2004, a pilot study led by Gert Bronfort, et. al., aimed to assess the feasibility of recruiting patients with sciatica and evaluating their compliance for a potential larger randomized clinical trial. The study also sought to gauge the responsiveness of key outcome measures associated with different treatment modalities.
Thirty-two participants were randomly assigned to one of three groups: spinal manipulation (n=11), epidural steroid injections (n=11), or self-care education (n=10). Due to the small sample size, no direct comparisons between the groups were planned.
Results at the 12-week mark, the end of the treatment phase, revealed significant improvements in several outcome measures. These included the Oswestry disability score, with a mean improvement of 22.9 (standard deviation [SD] 19.9) and a notable effect size (ES) of 1.8. Leg pain severity also exhibited substantial improvement, with a mean reduction of 2.9 (SD 1.7) and an ES of 1.7. Additionally, the assessment of whether symptoms were bothersome showed a mean improvement of 25.2 (SD 16.0) and an ES of 1.6. Overall, 24 out of 32 patients reported being either “very satisfied” or “completely satisfied,” with 22 patients experiencing 75% or 100% improvement in their symptoms.
By the 52-week follow-up, leg pain severity remained the most improved outcome measure, with a mean reduction of 2.3 (SD 2.6) and an ES of 1.35. This was followed by improvements in the Oswestry disability score (mean reduction of 15.6; SD 20; ES 1.2) and the assessment of bothersome symptoms (mean improvement of 18.1; SD 22.6; ES 1.1). Eighteen patients reported being either “very satisfied” or “completely satisfied,” with 15 patients noting a 75% or 100% improvement.
In conclusion, this pilot study suggests that recruiting patients with subacute and chronic sciatica and ensuring compliance for a full-scale randomized clinical trial is feasible. These findings provide valuable insights into the potential effectiveness of different treatment options for sciatica and lay the groundwork for future research in this area.
Reference: Bronfort, G., Evans, R. L., Maiers, M., & Anderson, A. V. (2004). Spinal manipulation, epidural injections, and self-care for sciatica: a pilot study for a randomized clinical trial. Journal of manipulative and physiological therapeutics, 27(8), 503-508.