A Carralero-Martínez1,2, M A Muñoz Pérez3,4,5, R Pané-Alemany1, L Blanco-Ratto1,6, S Kauffmann1,6,7, I Ramírez-García8,9,10,11. 1. Rehabilitación Abdomino-Pelviana (RAPbarcelona SL), Barcelona, Spain. 2. Servicio de Ginecología, Instituto Clínic de Ginecología, Obstetricia y Neonatología, Hospital Clínic de Barcelona, Barcelona, Spain. 3. Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP-Jordi Gol), Barcelona, Spain. 4. Institut Català de la Salut (ICS), Barcelona, Spain. 5. Departament de Pediatria, Obstetricia i Ginecologia i Medicina Preventiva, Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain. 6. Fundació Universitària del Bages (FUB), Barcelona, Spain. 7. Servicio de Fisioterapia, Womens Salud y Bienestar de la Mujer SL, Barcelona, Spain. 8. Rehabilitación Abdomino-Pelviana (RAPbarcelona SL), Barcelona, Spain. inesrg@blanquerna.url.edu. 9. Servicio de Fisioterapia, Instituto Médico Tecnológico SL, Barcelona, Spain. inesrg@blanquerna.url.edu. 10. Blanquerna School of Health Science-Universitat Ramon Llull, Barcelona, Spain. inesrg@blanquerna.url.edu. 11. Universidad Internacional de Catalunya (UIC), Barcelona, Spain. inesrg@blanquerna.url.edu.
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.
RCT Entities:
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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