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

NCT06908200 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-04-03

No results posted yet for this 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).

Conditions

  • Chronic Pelvic Pain

Interventions

DEVICE

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

OTHER

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

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-10
Primary Completion
2025-06-10
Completion
2025-06-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06908200 on ClinicalTrials.gov