Fujian University of Traditional Chinese Medicine, Fuzhou, China.
Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Fuzhou, China.
JMIR Res Protoc. 2024 Sep 30;13:e63852. doi: 10.2196/63852.
Lumbar disc herniation (LDH) has become a serious public health and socioeconomic problem. Tuina is a Chinese medicine treatment method based on meridian acupuncture theory and modern anatomy. Tuina can relieve pain and muscle tension and improve functional disorders; this massage is performed by pressing, kneading, pushing, pulling, and shaking the skin, muscles, and bones. However, the mechanism of action and the effect of Tuina as an external treatment on the activities of the central nervous system to relieve LDH pain is unclear. Therefore, we performed functional magnetic resonance imaging (fMRI), which is widely used in pain-related research, as it can detect the effects of different types of pain on brain activity.
Our randomized controlled parallel-group trial aims to compare the effects of Tuina with those of transcutaneous electrical nerve stimulation (TENS) with traction in patients with LDH.
This trial will be conducted between May 2024 and April 2025 in the Rehabilitation Hospital affiliated to Fujian University of Traditional Chinese Medicine. Seventy-six participants with LDH will be enrolled for this trial and randomly assigned to 2 groups: Tuina intervention group and TENS with traction intervention group. Participants in both groups will receive treatment for 14 days. fMRI will be performed for the main pain measurements by assessing the effect of the intervention on brain activity before and after the end of the intervention. Short-Form McGill Pain Questionnaire, pressure pain thresholds, and the Oswestry disability index will be used to reflect the degree of pain and lumbar dysfunction, and the results will be used as secondary outcome measurements.
The study protocol has been approved by the ethics review committee of The Rehabilitation Hospital affiliated to Fujian University of Traditional Chinese Medicine. This study was registered on May 1, 2024, with the Chinese Clinical Trial Registry. Data collection began on May 2024 and is expected to end on April 2025. Currently, data from this trial are in the collection phase, and no data analysis has been performed. As of July 1, 2024, we have collected data from 21 patients. The results of this trial are expected to be submitted for publication in September 2025.
This clinical trial will compare the effectiveness of Tuina with that of TENS with traction in the treatment of patients with LDH and will show the cerebral mechanism of Tuina in LDH treatment by using fMRI. The results of our trial will be helpful in clarifying the cerebral mechanism of Tuina in the treatment of LDH and provide a solid foundation for Tuina therapy research.
Chinese Clinical Trial Registry ChiCTR2400083784; https://www.chictr.org.cn/showproj.html?proj=225157.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/63852.
腰椎间盘突出症（LDH）已成为严重的公共卫生和社会经济问题。推拿是一种基于经络针灸理论和现代解剖学的中医治疗方法。推拿可以缓解疼痛和肌肉紧张，改善功能障碍；这种按摩是通过按压、揉捏、推压、拉伸和摇晃皮肤、肌肉和骨骼来进行的。然而，推拿作为一种外部治疗方法对中枢神经系统活动的作用机制以及缓解 LDH 疼痛的效果尚不清楚。因此，我们进行了功能磁共振成像（fMRI），它广泛应用于疼痛相关研究，因为它可以检测不同类型的疼痛对大脑活动的影响。
我们的随机对照平行组试验旨在比较推拿与经皮神经电刺激（TENS）联合牵引治疗 LDH 患者的效果。
本试验将于 2024 年 5 月至 2025 年 4 月在福建中医药大学附属康复医院进行。将招募 76 名 LDH 患者参加本试验，并随机分为推拿干预组和 TENS 联合牵引干预组。两组参与者均接受 14 天的治疗。通过评估干预结束前后干预对大脑活动的影响，进行主要疼痛测量的 fMRI。使用简明 McGill 疼痛问卷、压痛阈值和 Oswestry 残疾指数来反映疼痛和腰椎功能障碍的程度，这些结果将作为次要结果测量。
研究方案已获得福建中医药大学附属康复医院伦理审查委员会的批准。本研究于 2024 年 5 月 1 日在中国临床试验注册中心注册。数据收集于 2024 年 5 月开始，预计于 2025 年 4 月结束。目前，本试验的数据处于收集阶段，尚未进行数据分析。截至 2024 年 7 月 1 日，我们已经收集了 21 名患者的数据。本试验的结果预计将于 2025 年 9 月提交发表。
本临床试验将比较推拿与 TENS 联合牵引治疗 LDH 患者的疗效，并通过 fMRI 显示推拿治疗 LDH 的脑机制。本试验的结果将有助于阐明推拿治疗 LDH 的脑机制，并为推拿治疗研究提供坚实的基础。
中国临床试验注册中心 ChiCTR2400083784；https://www.chictr.org.cn/showproj.html?proj=225157。
国际注册报告标识符（IRRID）：DERR1-10.2196/63852。
