Department of Traditional Chinese Sports and Health, College of Martial Arts, Shanghai University of Sport, No. 399 Changhai Street, Shanghai City, China.
Department of Occupational and Environmental Health, Hudson College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK, 73104, USA.
BMC Complement Med Ther. 2024 Mar 15;24(1):123. doi: 10.1186/s12906-024-04386-5.
Daoyin therapy (DT), an ancient therapeutic approach with a history spanning thousands of years, has traditionally been employed to address musculoskeletal pain and psychosomatic disorders. However, the application of DT for chronic neck pain (CNP) has received limited attention in the existing literature, and systematic randomized clinical trials (RCTs) in this context remain scarce. This manuscript outlines an RCT protocol designed to investigate whether DT is more effective at alleviating CNP in adult individuals compared to other interventions.
A 12-week RCT was conducted, with participants undergoing randomization into one of three groups: DT, Meditation + Fitness Exercise (M+FE), or a control group. Participants in the DT and M + FE groups attended their respective training classes three times per week for 12 weeks. Participants in the control group were required to attend health education workshops every 2 weeks. Following the 12-week intervention period, all participants underwent follow-up assessments at the 16th week. Outcome measures encompassed the Simplified Chinese Neck Pain and Disability Scale (SC-NPAD) and Visual Analog Scale (VAS) for pain assessment, Static Neck Posture Assessment (SNPA) to evaluate neck and shoulder posture and function, Short Form-36 (SF-36) to assess quality of life, and blood tests measuring 5-Hydroxytryptamine (5-HT), Norepinephrine/Noradrenaline (NE/NA), γ-aminobutyric acid (GABA), Adreno-Cortico-Tropic-Hormone (ACTH), β-Endorphin (β-EP), and Calcitonin-Gene-Related Peptide (CGRP) levels via high-performance liquid chromatography (HPLC), chemiluminescence immunoassay (CLIA), enzyme-linked immunosorbent assay (ELISA), and radioimmunoassay (RIA). Brain activity changes were monitored through MRI scans. Repeated measures analyses of variance (ANOVAs) will be used to evaluate the outcomes at baseline, at the 12th week, and at the 16th week. Generalized Estimating Equation (GEE) models will be applied to analyze changes in outcomes over time and differences between groups.
This trial aims to evaluate the efficacy of DT in comparison to other interventions and explore the neuroendocrine mechanisms underlying its effects in adults with CNP. If the intervention and procedures demonstrate feasibility and acceptability, there are plans to conduct a more extensive controlled trial. This could potentially pave the way for the broader application of DT, not only in the context of CNP but also for other chronic diseases.
This trial has been registered with the Chinese Clinical Trial Registry (Registration ID: [ChiCTR2400079571]).
导引疗法(DT)是一种具有数千年历史的古老治疗方法,传统上用于治疗肌肉骨骼疼痛和身心障碍。然而,DT 在慢性颈痛(CNP)中的应用在现有文献中受到限制,并且在这方面的系统随机临床试验(RCT)仍然很少。本文概述了一项 RCT 方案,旨在研究 DT 是否比其他干预措施更能有效缓解成年人群的 CNP。
进行了为期 12 周的 RCT,参与者随机分为三组:DT、冥想+健身运动(M+FE)或对照组。DT 和 M+FE 组的参与者每周参加三次培训课程,为期 12 周。对照组的参与者每两周参加一次健康教育讲座。12 周干预期结束后,所有参与者在第 16 周进行随访评估。结果测量包括简化中文版颈痛和残疾量表(SC-NPAD)和疼痛评估的视觉模拟量表(VAS)、评估颈部和肩部姿势和功能的静态颈部姿势评估(SNPA)、评估生活质量的简短形式 36 项健康调查(SF-36),以及通过高效液相色谱法(HPLC)、化学发光免疫分析(CLIA)、酶联免疫吸附试验(ELISA)和放射免疫分析(RIA)测量 5-羟色胺(5-HT)、去甲肾上腺素/肾上腺素(NE/NA)、γ-氨基丁酸(GABA)、促肾上腺皮质激素(ACTH)、β-内啡肽(β-EP)和降钙素基因相关肽(CGRP)水平的血液测试。通过磁共振成像(MRI)扫描监测大脑活动变化。将使用重复测量方差分析(ANOVA)来评估基线、第 12 周和第 16 周的结果。将应用广义估计方程(GEE)模型来分析随时间变化的结果差异和组间差异。
本试验旨在评估 DT 与其他干预措施相比的疗效,并探讨其在 CNP 成年患者中的作用的神经内分泌机制。如果干预和程序表现出可行性和可接受性,计划进行更广泛的对照试验。这可能为 DT 的更广泛应用铺平道路,不仅在 CNP 方面,而且在其他慢性疾病方面。
本试验已在中国临床试验注册中心(注册号:[ChiCTR2400079571])注册。