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Clinical Trials in Spain / NCT06908200
Recruiting Not applicable

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

NCT06908200 · tracked via the Priya Life Science Spain tracker
Sponsor
Hospital Clinic of Barcelona
Phase
Not applicable
Started
2022-05-10
Last updated
2025-04-03

Condition(s) studied

Chronic Pelvic Pain

Investigational drug(s) / intervention(s)

Radiofrequency therapymyofascial manual therapy

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

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

Study summary

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).

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Pain Level — 8 weeks
    Pain Level using the Verbal Numeric Scale (VNS). The scores go from 0 (lowest) to 10 (highest)

Trial sites (1)

FacilityCityRegionStatus
Hospital Clinic de Barcelona Barcelona Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06908200 on ClinicalTrials.gov ↗ ← All trials in Spain