In 2000, Bronfort, et. al., conducted study about Sciatica, which characterized by low back-related radiating leg pain, poses a significant health concern, prompting the need for effective nonoperative treatments. In this prospective, observer-blinded, pilot randomized clinical trial, researchers aimed to assess the feasibility of patient recruitment, compliance with study protocols, and the utility of data collection instruments for cost-effectiveness analysis. The study also sought to obtain variability estimates for sample-size calculations for a subsequent full-scale trial.

The study was conducted in primary contact chiropractic and medical clinics, targeting individuals aged 20 to 65 with sciatica. The interventions included medical care, chiropractic care, and epidural steroid injections. Self-report questionnaires were administered at baseline, 3 weeks, and 12 weeks post-randomization, covering aspects such as pain severity, symptom frequency, disability, medication use, global improvement, satisfaction, and healthcare utilization.

Out of 706 individuals screened, over 90% did not meet entrance criteria, mainly due to the duration of the complaint exceeding 3 months. Twenty patients were randomized into the study. All three intervention groups demonstrated substantial improvements in patient-rated outcomes at the 12-week mark. Leg pain, back pain, frequency and bothersomeness of leg symptoms, and Roland-Morris disability score showed percent improvements ranging from 50% to 84%, with corresponding effect sizes from 0.8 to 2.2. Bothersomeness of leg symptoms exhibited the highest responsiveness and the largest effect size. All within-group changes from baseline were statistically significant (P < 0.01). No between-group comparisons were conducted due to the small sample size.

Pilot studies are crucial for evaluating the feasibility of larger trials. While recruitment for a full-scale 2 to 12-week study proved challenging, the results suggested substantial interest among patients with more chronic sciatica. Collaboration with health maintenance organizations could enhance clinician referrals and optimize recruitment. High patient and provider compliance indicated the feasibility of most study protocols. A suggested modification, replacing the medication group with a minimal intervention control group, led to a planned second pilot study for patients with sciatica lasting more than 4 weeks before attempting a full-scale trial.

Reference: Bronfort, G., Evans, R. L., Anderson, A. V., Schellhas, K. P., Garvey, T. A., Marks, R. A., & Bittell, S. (2000). Nonoperative treatments for sciatica: a pilot study for a randomized clinical trial. Journal of manipulative and Physiological Therapeutics, 23(8), 536-544.