A pilot study for a randomized clinical trial assessing chiropractic care, medical care, and self-care education for acute and subacute neck pain patients

OBJECTIVE: To conduct a pilot study in preparation for a full-scale randomized clinical trial assessing conservative treatments for acute and subacute neck pain. Study design Prospective, randomized pilot study. SETTING: Primary contact chiropractic and medical clinics. PATIENTS: Ages 21 to 65 with current episode of neck pain less than 12 weeks in duration. Outcome measures Patient self-report questionnaires and cervical spine motion were assessed at baseline and 3 and 12 weeks post-randomization. INTERVENTIONS: Chiropractic spinal manipulation, prescription medications, and self-care education. RESULTS: Recruitment took place over a 1-month period. Twenty-eight patients were randomized to treatment, and 1 patient (medical care group) refused their treatment assignment and was lost to further follow-up. Twenty-three patients were either "very satisfied" or "completely satisfied" with the care they received in the study. More than half the patients reported 75% or 100% improvement (n = 17). No between-group comparisons were planned or performed due to the small sample size. CONCLUSION: Recruitment of patients appears feasible for a full-scale randomized clinical trial evaluating chiropractic spinal manipulation, medical care, and self-care education for acute and subacute neck pain. Patient and provider compliance with study protocols was excellent, and the pilot study allowed us to further develop and optimize our data collection processes. Although pilot studies such as these require substantial time, money, and effort, they provide valuable information for future research efforts.