Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: study protocol for a randomized controlled trial

电容电阻式单极射频治疗慢性盆腔疼痛综合征的疗效:一项随机对照试验的研究方案

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Abstract

BACKGROUND: Chronic pelvic pain syndrome (CPPS) is a multifactorial disorder that affects 5.7% to 26.6% of women and 2.2% to 9.7% of men, characterized by hypersensitivity of the central and peripheral nervous system affecting bladder and genital function. People with CPPS have much higher rates of psychological disorders (anxiety, depression, and catastrophizing) that increase the severity of chronic pain and worsen quality of life. Myofascial therapy, manual therapy, and treatment of trigger points are proven therapeutic options for this syndrome. This study aims to evaluate the efficacy of capacitive resistive monopolar radiofrequency (CRMRF) at 448 kHz as an adjunct treatment to other physiotherapeutic techniques for reducing pain and improving the quality of life of patients with CPPS. METHODS: This triple-blind (1:1) randomized controlled trial will include 80 women and men with CPPS. Participants will be randomized into a CRMRF activated group or a CRMRF deactivated group and receive physiotherapeutic techniques and pain education. The groups will undergo treatment for 10 consecutive weeks. At the beginning of the trial there will be an evaluation of pain intensity (using VAS), quality of life (using the SF-12), kinesiophobia (using the TSK-11), and catastrophism (using the PCS), as well as at the sixth and tenth sessions. DISCUSSION: The results of this study will show that CRMRF benefits the treatment of patients with CPPS, together with physiotherapeutic techniques and pain education. These results could offer an alternative conservative treatment option for these patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT03797911 . Registered on 8 January 2019.

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