Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06908200

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

Led by Hospital Clinic of Barcelona · Updated on 2025-04-03

80

Participants Needed

1

Research Sites

161 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women at least 18 years old
  • Pelvic pain lasting at least 6 months
  • Diagnosed with myofascial syndrome of the pelvic floor muscles by a specialist
  • Pelvic pain intensity greater than 4 on the Visual Analog Scale in the last 3 months
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Currently pregnant
  • Given birth within the last year
  • History of vulvovaginal pathology
  • Metal implants or active infection contraindicating radiofrequency use
  • History of pelvic cancer or received chemotherapy, radiotherapy, or brachytherapy

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Trial Site Locations

Total: 1 location

1

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Actively Recruiting

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Research Team

C

Carla Box, PT, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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