Shin Byung-Cheul, Kim Me-Riong, Cho Jae-Heung, Jung Jae-Young, Kim Koh-Woon, Lee Jun-Hwan, Nam Kibong, Lee Min Ho, Hwang Eui-Hyoung, Heo Kwang-Ho, Kim Namkwen, Ha In-Hyuk
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.
Trials. 2017 Jan 17;18(1):26. doi: 10.1186/s13063-016-1756-8.
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.
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.
虽然脊柱推拿整复疗法是一种主要在韩国广泛用于治疗与腰痛（LBP）相关疾病的韩国手法治疗，但关于脊柱推拿整复疗法比较疗效的精心设计的研究却很匮乏。
方法/设计：本研究是一项三臂、多中心、实用随机对照试验的方案。将在四家韩医医院招募60名重度非急性腰痛患者（疼痛持续时间至少3周，数字评定量表（NRS）≥5）。参与者将被随机分配到脊柱推拿整复组（n = 20）、常规护理组（n = 20）或脊柱推拿整复加常规护理组（n = 20），进行为期6周的治疗。常规护理将包括口服传统药物、物理治疗和腰痛护理教育。试验将在结果评估者和统计学家不知情的情况下进行。主要终点将是随机分组后第7周时的腰痛NRS。次要结局包括腿痛NRS、奥斯威斯利功能障碍指数（ODI）、患者总体变化印象（PGIC）、可信度和期望问卷、腰椎活动度（ROM）、欧洲五维健康量表（EQ - 5D）健康调查、健康效用指数III（HUI - III）以及经济评估和安全性数据。治疗后随访将在治疗结束后的1周、4周和10周进行。
本研究将评估脊柱推拿整复疗法与传统常规护理相比的比较疗效。将分析成本和效果（效用）数据以进行探索性成本 - 效果分析。如果这项初步研究由于样本量小而未得出明确结论，这些结果将用作初步结果，以计算未来大规模临床试验的样本量，并有助于评估全面多中心试验的可行性。
临床研究信息服务（CRIS），KCT0001850。于2016年3月17日注册。
