Abstract
BACKGROUND: In chronic obstructive pulmonary disease (COPD) management, greater emphasis has been placed on symptomatic improvement and enhanced quality of life in patients. Manual therapy among respiratory rehabilitation programs has received much attention recently, with the publication of numerous studies. In South Korea, a method known as Chuna Manual Therapy (CMT) has been applied in the management of COPD patients and in clinical practice, but the clinical basis for safety and effectiveness is yet to be established. Therefore, rigorously designed randomized controlled trials are required. We aimed to evaluate the feasibility of assessing the add-on effect and safety of CMT administered with standard Western medicine therapy for the treatment of COPD. METHODS: This is a randomized, single-blind, single-center clinical pilot trial. Patients with COPD receiving standard drug therapy are randomly divided into an experimental group (n = 20) and a control group (n = 20) at a 1:1 ratio. The experimental group receives CMT adding to the standard medical therapy once a week for 8 weeks. The control group receives only the standard drug treatment. The trial is conducted with an outcome assessor and statistician blinding. The primary outcome is the 6-minute walk test. The secondary outcomes include the pulmonary function test, the Modified Medical Research Council, visual analog scale for dyspnea, COPD assessment test, quality of life using the St. George's respiratory questionnaire, EuroQOL five dimensions questionnaire, and Korean pattern identification questionnaire. Adverse events are also be evaluated. CONCLUSIONS: The results of this study will provide the feasibility of a large-scale clinical trial to establish high-quality clinical evidence of CMT for COPD. TRIAL REGISTRATION: Korean Clinical Trial Registry (http://cris.nih.go.kr; registration number: KCT0006119).