The effectiveness and safety of Chuna manual therapy adjuvant to Western medicine in patients with chronic obstructive pulmonary disease

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).Abbreviations: 6-MWT = six-minute walk test, AE = adverse event, CMT = Chuna manual therapy, COPD = chronic obstructive pulmonary disease, CTCAE = Common Terminology Criteria for Adverse Events, EQ-5D = EuroQOL five dimensions questionnaire, FEV1 = forced expiratory volume in one second, FVC = forced vital capacity, ITT = intended to treat, LOCF = last observation carried forward, MT = manual therapy, PP = per protocol, SAE = serious adverse event.

The Effectiveness and Safety of Chuna Manual Therapy Adjuvant to Western Medicine in Patients with Chronic Obstructive Pulmonary Disease: A Randomized, Single-Blind, Investigator-Initiated, Pilot Trial

“…The CMT intervention was administered once a week for 8 weeks, and assessments were performed at baseline and after 4, 8, and 12 weeks of intervention. The protocol has already been published [21] and a flow diagram of the study is shown in Figure 1.…”

“…The CMT intervention was administered once a week for 8 weeks, and assessments were performed at baseline and after 4, 8, and 12 weeks of intervention. The protocol has already been published [21] and a flow diagram of the study is shown in Figure 1. showing a forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio of <0.70 [4] and currently undergoing standard drug therapy 3.…”

“…The protocol of this study was registered at the Korean Clinical Trial Registry (http: //cris.nih.go.kr (accessed on 8 April 2021); registration number: KCT0006119) and has already been published [21]. This study was approved by the Institutional Review Board of the Kyung Hee University Korean Medicine Hospital (KOMCIRB 2020-12-006-002).…”