Actively Recruiting
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
Eligibility Criteria
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
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
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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