Effect of Radiofrequency in Women With Chronic Pelvic Pain With an Associated Myofascial Syndrome Versus Myofascial Therapy and no Treatment

Официальное название

Effect of Radiofrequency in Women With Chronic Pelvic Pain With an Associated Myofascial Syndrome Versus Myofascial Therapy and no Treatment: a Randomized Clinical Trial

Обзор

A randomised clinical trial is being conducted in the Gynecology Department of the Hospital Clinic de Barcelona in women presenting chronic pelvic pain syndrome due to a myofascial cause which is over a 4 score in the VAS scale and not related to an obstetric injury. This study presents 4 groups; two groups receive 8 radiofrequency sessions, one group receives 8 sessions of myofascial release therapy (MRT) and the last group receives no treatment at all (NT). The two RF groups have been divided into a RF intervention group (RFIG) and a RF control group (RFCG) which receives sham treatment. The RF groups are double-blinded. Other than RF, both groups perform daily Thiele massage at home. The sessions last for 20 minutes and take place once a week during 8 weeks. The main variable evaluated is the level of pain during the muscular assessment carried out by an expert pelvic floor physical therapist using the Verbal numeric Scale in the first session and at the end of the 8 sessions. Secondary variables are: sexual function (throughout FSFI questionnaire), pain catastrophizing (ECD), quality of life (EQ5D), anxiety and depression (HADS), central sensitization (CSI) as well as other pelvic floor dysfunction symptoms (PFDI).

Вмешательства

• Устройство Radiofrequency therapy
  Radiofrequency or myofascial manual therapy sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home
• Другое myofascial manual therapy
  Myofascial manual therapy sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home

Первичные конечные точки

• Pain Level [Срок оценки: 8 weeks]

Вторичные конечные точки (5)

• Sexual function [Срок оценки: 8 weeks]
• Quality of life (QoL) [Срок оценки: 8 weeks]
• Pain catastrophizing [Срок оценки: 8 weeks]
• Anxiety and depression [Срок оценки: 8 weeks]
• Central sensitization [Срок оценки: 8 weeks]

Критерии участия

Inclusion criteria included women who were:

• At least 18 years of age
• Presenting with pelvic pain persisting for at least 6 months
• Diagnosed with myofascial syndrome of the pelvic floor muscles (PFM) by a specialist based on physical assessment
• Presenting with pelvic pain intensity greater than 4 on the Visual Analog Scale (VAS) in the last 3 months
• Agreed to sign the informed consent form.

Exclusion criteria included the following:

• Patients who were pregnant
• Postpartum patients who had given birth within the last year
• Patients with a history of vulvovaginal pathology
• Contraindications for the use of radiofrequency: metal implants or active infection
• Patients with a history of pelvic cancer, including those who had undergone chemotherapy, radiotherapy, and/or brachytherapy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Clinic de Barcelona — Barcelona

Идентификаторы

NCT: NCT06908200 · HCB/2021/0313 · HCB/2021/0313

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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