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.


METHODS
Primary contact chiropractic and medical clinics.


METHODS
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.


METHODS
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.


CONCLUSIONS
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.
Evans
Roni
R
Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, 2501 W. 84th Street, Bloomington, MN 55431, USA. revans@nwhealth.edu
Bronfort
Gert
G
Bittell
Sarah
S
Anderson
Alfred V
AV
D000208:Acute Disease; D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D026882:Manipulation, Chiropractic / Q000379:methods* / Q000592:standards*; D008875:Middle Aged; D019547:Neck Pain / Q000534:rehabilitation*; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D018579:Patient Selection; D010865:Pilot Projects; D011446:Prospective Studies; D016059:Range of Motion, Articular; D012648:Self Care / Q000379:methods; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States