Abstract
BackgroundWhile Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce.Methods/designThis study is the protocol for a three-armed, multicenter, pragmatic randomized controlled pilot trial. Sixty severe nonacute LBP patients (pain duration of at least 3 weeks, Numeric Rating Scale (NRS) ≥5) will be recruited at four Korean medicine hospitals. Participants will be randomly allocated to the Chuna group (n = 20), usual care group (n = 20), or Chuna plus usual care group (n = 20) for 6 weeks of treatment. Usual care will consist of orally administered conventional medicine, physical therapy, and back pain care education. The trial will be conducted with outcome assessor and statistician blinding. The primary endpoint will be NRS of LBP at week 7 post randomization. Secondary outcomes include NRS of leg pain, the Oswestry Disability Index (ODI), the Patient Global Impression of Change (PGIC), the Credibility and Expectancy Questionnaire, lumbar range of motion (ROM), the EuroQol-5 Dimension (EQ-5D) health survey, the Health Utility Index III (HUI-III), and economic evaluation and safety data. Post-treatment follow-ups will be conducted at 1, 4, and 10 weeks after conclusion of treatment.DiscussionThis study will assess the comparative effectiveness of Chuna manual therapy compared to conventional usual care. Costs and effectiveness (utility) data will be analyzed for exploratory cost-effectiveness analysis. If this pilot study does not reach a definite conclusion due to its small sample size, these results will be used as preliminary results to calculate sample size for future large-scale clinical trials and contribute in the assessment of feasibility of a full-scale multicenter trial.Trial registrationClinical Research Information Service (CRIS), KCT0001850. Registered on 17 March 2016.
Highlights
While Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce
This study will assess the comparative effectiveness of Chuna manual therapy compared to conventional usual care
The hypotheses of this study are as follows: (1) Chuna manual therapy will be more effective and safer than conventional usual care in nonacute LBP patients and (2) concurrent treatment consisting of Chuna manual therapy and usual care will be more effective than Chuna alone or conventional usual care alone in nonacute LBP patients. The objectives of this Pilot Chuna Research Network (pCRN) study are to investigate the following in nonacute LBP patients: (1) the comparative effectiveness and safety of Chuna manual therapy compared to conventional usual care through comparison of pain, functionality, quality of life parameters and adverse events, (2) the effectiveness and safety of a concurrent treatment consisting of Chuna manual therapy and usual care, which is reflective of actual clinical practice, through comparison of two single treatment groups of Chuna manual therapy and usual care, and a combined treatment group of Chuna manual therapy with usual care and (3) costs and effectiveness data of the three groups for exploratory cost-effectiveness analysis
Summary
While Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce. Spinal manipulative therapy (SMT) is extensively used for acute and chronic LBP, and its efficacy has been reported in numerous randomized controlled trials (RCTs) and systematic reviews (SRs). Upon closer inspection, the two Cochrane reviews on SMT for acute and chronic LBP mainly use search terms such as manipulation, osteopathy, and chiropractic, and do not include Korean Chuna manual therapy or Chinese Tuina [3]. Literally meaning manual treatment in Korean, is a Korean spinal manipulation that has developed absorbing aspects of Chinese Tuina, chiropractic manipulation, and osteopathic medicine over time. Chuna incorporates radiology-based diagnosis, which is not customary for Chinese SMT, and includes meridian theory, meridian muscle concepts, and organ pattern identification diagnosis not usually seen in chiropractic manipulation or osteopathic medicine [7]. In quality assessment of RCTs in accordance with the Consolidated Standards of Reporting Trials (CONSORT) Statement [9], weaknesses regarding identification in title or structured summary in abstract, inadequate trial design description, statistical limitation from small sample size, inaccuracy of randomization and allocation process, difficulty in blinding, and insufficient reporting of participant flow and estimated effect size of interventions and its precision were reported [10]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
