背景:慢性前列腺炎/慢性盆腔疼痛综合征是一种非常普遍的综合征。既往研究表明,体外冲击波疗法和肌筋膜释放疗法可改善慢性前列腺炎/慢性盆腔疼痛综合征(CP/CPPS)患者的生活质量。理论上,体外冲击波疗法和肌筋膜释放疗法联合治疗CP/CPPS可能具有显著优势.我们,因此,为进行精心设计的随机对照试验提供方案,以比较每种疗法的疗效和安全性.
方法:拟议的研究将是一项三组随机对照试验(RCT)设计,包括来自东南大学附属中大医院的150名参与者,将参与者均等分配到三个干预组。研究时间为8周,其中包括4周的治疗期和4周的随访期。主要结果将是表面肌电图(sEMG)评估和美国国立卫生研究院慢性前列腺炎症状指数(NIH-CPSI)的变化。次要结果将包括三维量化的变化,剪切波弹性成像(SWE),和交感神经皮肤反应(SSR)测试。评估将在干预前进行(T0),在第5次干预(T1)之前,在第8次干预(T2)之后,第8次干预结束后第4周(T3)。
结论:该试验将比较单一体外冲击波疗法之间的疗效差异,单肌筋膜释放疗法,联合治疗,为CP/CPPS患者选择最合适的治疗方案。CP/CPPS的可能发病机制也将通过比较每个客观和主观测量(NIH-CPSI评分,sEMG,SWE,SSR)。
背景:注册名称:慢性盆腔疼痛综合征的体外冲击波和肌筋膜释放疗法。
背景:NCT05659199。注册日期:2022年12月。
BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome is a highly prevalent syndrome. Previous studies showed that extracorporeal shockwave therapy and myofascial release therapy could improve the quality of life in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Theoretically, combined therapy with extracorporeal shockwave therapy and myofascial release therapy will likely have significant advantages in treating CP/CPPS. We, therefore, present a protocol for conducting a well-designed randomized controlled
trial to compare the efficacy and safety of each therapy.
METHODS: The proposed
study will be a three-group randomized control
trial (RCT) design that includes 150 participants from Zhongda Hospital Affiliated to Southeast University, with equal allocation of participants to the three intervention groups. The
study duration will be 8 weeks, which includes a 4-week treatment period and a 4-week follow-up period. The primary outcome will be the changes in surface electromyography (sEMG) assessment and National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI). The secondary outcomes will include the changes in three-dimensional quantification, shear wave elastography (SWE), and sympathetic skin response (SSR) testing. Assessments will be conducted before the intervention (T0), before the 5th intervention (T1), immediately after the 8th intervention (T2), and the 4th week after the end of the 8th intervention (T3).
CONCLUSIONS: This
trial will compare the differences in efficacy between single extracorporeal shockwave therapy, single myofascial release therapy, and combined therapy to select the most appropriate treatment option for patients with CP/CPPS. The possible pathogenesis of CP/CPPS would also be analyzed by comparing the intercorrelation between each objective and subjective measurement (NIH-CPSI score, sEMG, SWE, SSR).
BACKGROUND: The name of the registry: Extracorporeal Shockwave and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome.
BACKGROUND: NCT05659199. Date of registration: December 2022.