Department of Rehabilitation, First Hospital of Nanping City.
Department of Rehabilitation, Nanping People's Hospital, Fujian Province, Nanping.
Medicine (Baltimore). 2021 Jan 29;100(4):e24448. doi: 10.1097/MD.0000000000024448.
Chronic low back pain (CLBP) is 1 of the common clinical diseases, and many treatment methods can only improve the symptoms of pain in the short term. Traditional Chinese sports - Baduanjin has been proven to have a positive effect on chronic low back pain. However, the quality of the research is low, the sample size is small, and safety observations are lacking. We describe the protocol of a randomized controlled trial to study the efficacy and safety of Baduanjin chronic low back pain.
This randomized, controlled, evaluator-blind, two-arm, parallel clinical trial will include 90 outpatients with chronic low back pain recruited from the First Hospital of Nanping City, Fujian Province. The patients were randomly assigned to the intervention group (Baduanjin exercise training) and the control group (not receiving any special exercise training) at a ratio of 1:1. Patients in the intervention group will receive Baduanjin exercise training 3 times a week for 24 weeks. The 2 groups received a 4- week follow-up observation at 24 weeks. The main result from the intervention before intervention to 24 weeks later, and the follow-up of 4 changes the visual analog scale score at weeks, and by independent t are tested groups. It will also review the Pain-related disability index, The Quebec Back Pain Disability Scale, Health-related quality of life, Roland Morris (Roland Morris) Disability Questionnaire, Overall Perceived Effect (OPE) and safety Compare. Cost data for cost-benefit and cost-benefit analysis will be collected.
This will be the first study to compare the effectiveness and safety of Baduanjin for patients with chronic low back pain. The results may help healthcare professionals make clinical decisions and may reduce the cost of treatment for this disease.
ChiCTR2000033908.
慢性下背痛（CLBP）是一种常见的临床疾病，许多治疗方法只能在短期内改善疼痛症状。传统的中国运动 - 八段锦已被证明对慢性下背痛有积极的效果。然而，研究质量低，样本量小，缺乏安全性观察。我们描述了一项随机对照试验的方案，以研究八段锦治疗慢性下背痛的疗效和安全性。
这是一项随机、对照、评估者盲法、双臂、平行的临床试验，将包括 90 名来自福建省南平市第一医院的慢性下背痛门诊患者。患者以 1:1 的比例随机分配到干预组（八段锦运动训练）和对照组（不接受任何特殊运动训练）。干预组患者每周接受 3 次八段锦运动训练，共 24 周。2 组在 24 周后进行 4 周的随访观察。主要结果为干预前至 24 周后的变化，以及 4 周随访时的视觉模拟评分变化，采用独立 t 检验进行组间比较。还将比较疼痛相关残疾指数、魁北克下背痛残疾量表、健康相关生活质量、Roland Morris（Roland Morris）残疾问卷、总体感知效果（OPE）和安全性。将收集成本效益和成本效益分析的成本数据。
这将是第一项比较八段锦对慢性下背痛患者有效性和安全性的研究。研究结果可能有助于医疗保健专业人员做出临床决策，并可能降低这种疾病的治疗成本。
ChiCTR2000033908。
