title: Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study).
abstract: 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 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.
  
  
  
  This 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.
  
  
  
  Clinical Research Information Service (CRIS), KCT0001850 . Registered on 17 March 2016.
authors.affiliation: Spine and Joint Center, Pusan National University Korean Medicine Hospital, Yangsan, Republic of Korea.|Department of Korean Rehabilitation Medicine, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea.
authors.forename: Byung-Cheul
authors.initials: BC
authors.lastname: Shin
authors.affiliation: Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 858 Eonju-ro, Gangnam-gu, Seoul, 135-896, Republic of Korea.
authors.forename: Me-Riong
authors.initials: MR
authors.lastname: Kim
authors.affiliation: Department of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Jae-Heung
authors.initials: JH
authors.lastname: Cho
authors.affiliation: Department of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Jae-Young
authors.initials: JY
authors.lastname: Jung
authors.affiliation: Department of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Koh-Woon
authors.initials: KW
authors.lastname: Kim
authors.affiliation: Clinical Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.|Korean Medicine Life Science, University of Science and Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
authors.forename: Jun-Hwan
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Mokhuri Neck and Back Hospital, Seoul, Republic of Korea.
authors.forename: Kibong
authors.initials: K
authors.lastname: Nam
authors.affiliation: Mokhuri Neck and Back Hospital, Seoul, Republic of Korea.
authors.forename: Min Ho
authors.initials: MH
authors.lastname: Lee
authors.affiliation: Spine and Joint Center, Pusan National University Korean Medicine Hospital, Yangsan, Republic of Korea.|Department of Korean Rehabilitation Medicine, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea.
authors.forename: Eui-Hyoung
authors.initials: EH
authors.lastname: Hwang
authors.affiliation: Spine and Joint Center, Pusan National University Korean Medicine Hospital, Yangsan, Republic of Korea.|Department of Korean Rehabilitation Medicine, School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea.
authors.forename: Kwang-Ho
authors.initials: KH
authors.lastname: Heo
authors.affiliation: Center for Comparative Effectiveness Research and Economic Evaluation in Korean Medicine, Pusan National University, Yangsan, Republic of Korea.
authors.forename: Namkwen
authors.initials: N
authors.lastname: Kim
authors.affiliation: Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 858 Eonju-ro, Gangnam-gu, Seoul, 135-896, Republic of Korea. hanihata@gmail.com.
authors.forename: In-Hyuk
authors.identifier: 0000-0002-5020-6723
authors.initials: IH
authors.lastname: Ha
mesh_terms: D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D057186:Comparative Effectiveness Research; D003362:Cost-Benefit Analysis; D004185:Disability Evaluation; D005260:Female; D017048:Health Care Costs; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis / Q000191:economics* / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D026201:Musculoskeletal Manipulations / Q000009:adverse effects / Q000191:economics*; D010147:Pain Measurement; D010865:Pilot Projects; D020127:Recovery of Function; D056910:Republic of Korea; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: Complementary therapies; Cost-benefit analysis; Low back pain; Protocol; Spinal manipulation