Department of Sport Rehabilitation, Shanghai University of Sport, Shanghai, China.
Department of Rehabilitation, Shanghai Xuhui Central Hospital / Zhongshan-Xuhui Hospital, Fudan University / Shanghai Clinical Research Center, Chinese Academy of Sciences, 966 Middle Huaihai Road, Shanghai, 200031, China.
Trials. 2020 Feb 11;21(1):164. doi: 10.1186/s13063-020-4045-5.
Primary dysmenorrhoea (PDM) is defined as a series of pain-dominated symptoms during and after menstruation without organic lesions. Nonsteroidal anti-inflammatory drugs and oral contraceptives are usually recommended as first-line therapy for the clinical treatment of PDM, but their widespread long-term application is controversial. Radial extracorporeal shock wave therapy (rESWT) has been widely applied in musculoskeletal rehabilitation because of its secure and noninvasive characteristics and its confirmed effect in improving pain symptoms. This research seeks to explore the efficacy of rESWT for PDM and the changes in brain function of patients with PDM.
This clinical research will be a randomised, blind, sham-controlled trial. Thirty-six patients with PDM will be randomly divided into the rESWT group (n = 18) and the sham rESWT group (n = 18). In the rESWT group, treatment will be applied once within 48 h of menstruation at six abdominal myofascial trigger points. The sham rESWT group will receive sham shockwave therapy on the same sites but without energy input. Other dysmenorrhoea-related treatments in both groups will be limited. The main indicators include the short form of the McGill Pain Questionnaire and the Cox Menstrual Symptom Scale. The secondary indicators include the Zung Self-rating Anxiety Scale and Self-rating Depression Scale and functional magnetic resonance imaging (fMRI) changes in brain regions. Results will be evaluated at the screening, at baseline, and before and after treatment, and adverse treatments will be examined. Inter- and intragroup analyses will be performed.
This randomised controlled study is designed to explore the immediate efficacy of rESWT for PDM. After rESWT treatment, PDM symptom tests and pain tests, as well as fMRI data, will be investigated for the potential connections between immediate neuroanalgesic mechanisms, which are associated with pain and brain networks. The main results will be used to assess the efficacy of rESWT, and secondary results will focus on improving the neurobiological understanding of disease treatment.
China Clinical Trial Register, ChiCTR1900020678. Registered on 13 January 2019.
原发性痛经（PDM）是指在月经期间和之后出现以疼痛为主的一系列症状，而没有器质性病变。非甾体抗炎药和口服避孕药通常被推荐作为 PDM 临床治疗的一线治疗药物，但它们的广泛长期应用存在争议。体外冲击波疗法（ESWT）因其安全、无创的特点以及在改善疼痛症状方面的确认效果，已广泛应用于肌肉骨骼康复领域。本研究旨在探讨 ESWT 治疗 PDM 的疗效以及 PDM 患者脑功能的变化。
本临床研究将采用随机、盲法、假对照试验。将 36 例 PDM 患者随机分为 ESWT 组（n=18）和假 ESWT 组（n=18）。在 ESWT 组中，在月经来潮后 48 小时内，在六个腹部肌筋膜触发点处进行一次治疗。假 ESWT 组将在相同部位接受假冲击波治疗，但不输入能量。两组其他与痛经相关的治疗将受到限制。主要指标包括麦吉尔疼痛问卷简表和考克斯月经症状量表。次要指标包括zung 焦虑自评量表和抑郁自评量表以及脑区功能磁共振成像（fMRI）变化。结果将在筛选期、基线期、治疗前后进行评估，并检查不良治疗情况。将进行组间和组内分析。
本随机对照研究旨在探讨 ESWT 治疗 PDM 的即刻疗效。在 ESWT 治疗后，将对 PDM 症状测试和疼痛测试以及 fMRI 数据进行调查，以研究与疼痛和大脑网络相关的即时神经镇痛机制之间的潜在联系。主要结果将用于评估 ESWT 的疗效，次要结果将侧重于改善对疾病治疗的神经生物学理解。
中国临床试验注册中心，ChiCTR1900020678。注册于 2019 年 1 月 13 日。
