A pilot study for a randomized clinical trial assessing chiropractic care, medical care, and self-care education for acute and subacute neck pain patients☆
Received 18 September 2001; received in revised form 30 October 2002
Abstract
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.
aDirector, Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, Bloomington, Minn, USA
bWolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, Bloomington, Minn, USA
cPrivate practice of chiropractic, Minnetonka, Minn, USA
dPain Assessment and Rehabilitation Center, Edina, Minn, USA
Submit requests for reprints to: Roni Evans, Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, 2501 W 84th Street, Bloomington, MN 55431, USA
☆ This study was funded by the Consortial Center for Chiropractic Research through the National Center for Complementary and Alternative Medicine and the National Institute of Arthritis, Musculoskeletal and Skin Diseases of the National Institutes of Health.
ABSTRACT