Objective: The purpose of this pilot clinical trial was to assess the feasibility of recruiting older adults with lumbar spinal stenosis (LSS) into a clinical trial that used different dosages of flexion-distraction manipulation.
Methods: This randomized controlled trial used a 4-group design. Three groups consisted of chiropractic flexion-distraction manipulation applied at different dosages (8, 12, or 18 treatments). The fourth group was given 8 treatments of placebo care. Feasibility measures included recruitment goals, adherence to various treatment schedules, credibility of the placebo treatment, and rates of adverse events. The primary outcome measure was the Swiss Spinal Stenosis Questionnaire, a validated self-report of LSS symptom severity and physical function.
Results: The recruitment and adherence goals of the study were met with a total of 60 subjects randomized (n = 15 per group) and most subjects attending at least 75% of their scheduled visits. No adverse events were reported by any of the subjects in the trial. Our placebo treatment did not appear to be credible; most subjects correctly guessed that they were receiving a placebo treatment. Between-group effect size estimates were small, indicating larger samples are needed for future studies.
Conclusion: This pilot study showed that it is feasible to recruit patients with LSS and that most subjects will adhere to a 6-week treatment schedule. The information gained from this trial will be useful to inform the design of larger trials.
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