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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).
Trials. 2017 01 17; 18(1):26.T

Abstract

BACKGROUND

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.

METHODS/DESIGN

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.

DISCUSSION

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.

TRIAL REGISTRATION

Clinical Research Information Service (CRIS), KCT0001850 . Registered on 17 March 2016.

Authors+Show Affiliations

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.Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 858 Eonju-ro, Gangnam-gu, Seoul, 135-896, Republic of Korea.Department of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, Republic of Korea.Department of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, Republic of Korea.Department of Korean Rehabilitation Medicine, Kyung Hee University, Seoul, Republic of Korea.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.Mokhuri Neck and Back Hospital, Seoul, Republic of Korea.Mokhuri Neck and Back Hospital, Seoul, Republic of Korea.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.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.Center for Comparative Effectiveness Research and Economic Evaluation in Korean Medicine, Pusan National University, Yangsan, Republic of Korea.Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, 858 Eonju-ro, Gangnam-gu, Seoul, 135-896, Republic of Korea. hanihata@gmail.com.

Pub Type(s)

Journal Article
Multicenter Study
Pragmatic Clinical Trial
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28095892

Citation

Shin, Byung-Cheul, et al. "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)." Trials, vol. 18, no. 1, 2017, p. 26.
Shin BC, Kim MR, Cho JH, et al. 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). Trials. 2017;18(1):26.
Shin, B. C., Kim, M. R., Cho, J. H., Jung, J. Y., Kim, K. W., Lee, J. H., Nam, K., Lee, M. H., Hwang, E. H., Heo, K. H., Kim, N., & Ha, I. H. (2017). 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). Trials, 18(1), 26. https://doi.org/10.1186/s13063-016-1756-8
Shin BC, et al. 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). Trials. 2017 01 17;18(1):26. PubMed PMID: 28095892.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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). AU - Shin,Byung-Cheul, AU - Kim,Me-Riong, AU - Cho,Jae-Heung, AU - Jung,Jae-Young, AU - Kim,Koh-Woon, AU - Lee,Jun-Hwan, AU - Nam,Kibong, AU - Lee,Min Ho, AU - Hwang,Eui-Hyoung, AU - Heo,Kwang-Ho, AU - Kim,Namkwen, AU - Ha,In-Hyuk, Y1 - 2017/01/17/ PY - 2016/06/14/received PY - 2016/12/14/accepted PY - 2017/1/19/entrez PY - 2017/1/18/pubmed PY - 2018/3/6/medline KW - Complementary therapies KW - Cost-benefit analysis KW - Low back pain KW - Protocol KW - Spinal manipulation SP - 26 EP - 26 JF - Trials JO - Trials VL - 18 IS - 1 N2 - BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), KCT0001850 . Registered on 17 March 2016. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/28095892/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__ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1756-8 DB - PRIME DP - Unbound Medicine ER -