Abstract
PURPOSE: Numerous studies have analyzed the effects of Chuna therapy, a manual therapy technique used in Korea, on musculoskeletal disorders. However, research on Chuna maintenance therapy (CMT), which aims to prevent the recurrence of disorders and improve health status through regular long-term application, is lacking. This protocol outlines a randomized clinical trial designed to evaluate the comparative effectiveness of CMT for chronic neck pain, particularly in cases where mild discomfort has become habitual. PATIENTS AND METHODS: This two-arm, multi-institutional, assessor-blinded, pragmatic randomized controlled trial will enroll 250 participants with chronic bothersome neck pain for more than 12 months and an average Numeric Rating Scale (NRS) score of 2-4 over the past month, recruited from seven Korean medicine hospitals. Participants will be randomly assigned to one of two groups: the CMT group or the self-care and exercise (SE) group. Over a total period of 20 weeks, the CMT group will receive 10 treatment sessions, while the SE group will receive 5 education sessions. After treatment completion, a follow-up will be conducted twice over a 6-week period. The primary outcome are the average neck pain NRS score and the Neck Disability Index (NDI), both assessed over the preceding 2 weeks. Secondary outcomes include the Visual Analog Scale, number of days with bothersome neck pain, recurrence, the Patient Global Impression of Change, Credibility and Expectancy Questionnaire, quality of life, cost-effectiveness evaluation, and safety assessments. For the primary analysis, group-specific areas under the curve for NRS and NDI will be calculated using a linear mixed model. The primary endpoint is the first follow-up visit (Visit 11) after treatment completion. CONCLUSION: The findings may inform clinical and policy decision-making by providing evidence on the effectiveness, safety, and cost-effectiveness of CMT. TRIAL REGISTRATION NUMBER: This study is registered at ClinicalTrials.gov (NCT06591221; September 7, 2024) and the Clinical Research Information Service (CRIS; KCT0009798).