Shanghai University of Traditional Chinese Medicine, Shuguang Hospital, Shanghai, China.
Shanghai University of Traditional Chinese Medicine, Yueyang Hospital of Integrated Traditional Chinese Medicine and Western Medicine, Shanghai, China.
BMJ Open. 2024 Mar 25;14(3):e081022. doi: 10.1136/bmjopen-2023-081022.
INTRODUCTION: Non-pharmacological interventions play a crucial role in the management of non-specific chronic low back pain (NSCLBP). One prime example is Tuina, a traditional Chinese manual therapy that incorporates pressing, kneading and rubbing techniques to alleviate physical discomfort and enhance overall well-being. It serves as a widely used technique in China and other East Asian countries. However, the effectiveness and safety of Tuina for managing NSCLBP have not been substantiated through rigorous clinical research. We sought to carry out a randomised controlled trial with an open-label design, blinded assessors and parallel arms to assess the effectiveness and safety of Tuina as a treatment for NSCLBP. The trial aims to provide high-quality evidence regarding the efficacy and safety of Tuina in improving outcomes for patients with NSCLBP. METHODS AND ANALYSIS: A total of 150 patients aged 18-60 years with NSCLBP will be recruited. Participants will be randomly assigned to one of the two groups. Both groups will receive standard health education. In addition, the treatment group will receive Tuina therapy, while the control group will participate in core stability exercises. Each group will undergo a total of 18 interventions over 6 weeks, with the interventions administered three times per week. The primary outcome measure is the patient's pain intensity, assessed using the Numerical Rating Scale, at week 6 following randomisation. Secondary outcomes encompass disability (measured by the Roland-Morris Disability Questionnaire), quality of life (assessed using the EuroQoL-5 dimensions questionnaire), adverse emotions (evaluated with the Pain Catastrophizing Scale, Tampa Scale of Kinesiophobia and Depression Anxiety Stress Scale), biomechanical outcomes, socioeconomic indicators (medication use, healthcare utilisation and absenteeism), patient satisfaction, treatment adherence and other relevant factors.The statistical analysis will follow the intention-to-treat principle. Two-way repeated measures analysis of variance will be used to compare the clinical data across different time points within both groups. ETHICS AND DISSEMINATION: The study protocol has received approval from the Ethics Committee of Shuguang Hospital, Shanghai University of Traditional Chinese Medicine (2023-1366-133-01). All study participants will be required to give written informed consent. The findings of the study will be submitted to a peer-reviewed journal for publication and presented at scientific conferences. Additionally, the participants will receive copies of the results. TRIAL REGISTRATION NUMBER: ChiCTR2300076257.
简介:非药物干预在非特异性慢性下背痛(NSCLBP)的管理中起着至关重要的作用。其中一个主要的例子是推拿,这是一种传统的中医手法治疗,包括按压、揉捏和摩擦技术,以缓解身体不适并提高整体健康水平。它是中国和其他东亚国家广泛使用的技术。然而,推拿治疗 NSCLBP 的有效性和安全性尚未通过严格的临床研究证实。我们旨在进行一项随机对照试验,采用开放标签设计、盲法评估和平行臂,以评估推拿作为 NSCLBP 治疗方法的有效性和安全性。该试验旨在提供高质量的证据,证明推拿在改善 NSCLBP 患者结局方面的疗效和安全性。
方法和分析:将招募 150 名年龄在 18-60 岁之间的 NSCLBP 患者。参与者将被随机分配到两组之一。两组均接受标准健康教育。此外,治疗组接受推拿治疗,对照组参加核心稳定性锻炼。两组均在 6 周内共接受 18 次干预,每周 3 次。主要结局测量指标是随机分组后第 6 周时患者的疼痛强度,使用数字评分量表评估。次要结局包括残疾(使用 Roland-Morris 残疾问卷测量)、生活质量(使用 EuroQoL-5 维度问卷评估)、不良情绪(使用疼痛灾难化量表、坦帕运动恐惧量表和抑郁焦虑压力量表评估)、生物力学结果、社会经济指标(药物使用、医疗保健利用和缺勤)、患者满意度、治疗依从性和其他相关因素。统计分析将遵循意向治疗原则。将使用双向重复测量方差分析比较两组内不同时间点的临床数据。
伦理和传播:该研究方案已获得上海中医药大学曙光医院伦理委员会的批准(2023-1366-133-01)。所有研究参与者都将被要求签署书面知情同意书。研究结果将提交给同行评议的期刊发表,并在科学会议上展示。此外,参与者将收到结果的副本。
试验注册号:ChiCTR2300076257。
Complement Ther Clin Pract. 2022-11
N Engl J Med. 2022-5-5