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A pilot study for a randomized clinical trial assessing chiropractic care, medical care, and self-care education for acute and subacute neck pain patients
Evans R, Bronfort G, Bittell S, Anderson AV
Journal of Manipulative and Physiological Therapeutics 2003 Sep;26(7):403-411
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: No; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 postrandomization. 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.
Reprinted from the Journal of Manipulative and Physiological Therapeutics with copyright permission from the National University of Health Sciences.

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