Actively Recruiting
Effect of Radiofrequency in Women With Chronic Pelvic Pain With an Associated Myofascial Syndrome Versus Myofascial Therapy and no Treatment: a Randomized Clinical Trial
Led by Hospital Clinic of Barcelona · Updated on 2025-04-03
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized clinical trial in women with chronic pelvic pain caused by a myofascial syndrome. The pain must be above a 4 score on the Visual Analog Scale (VAS) and unrelated to obstetric injury. The study aims to compare the effects of radiofrequency therapy, myofascial manual therapy, and no treatment on pain and other related symptoms in this population. The trial is sponsored by the Hospital Clinic of Barcelona and includes women aged 18 and older with pelvic pain lasting at least 6 months. Participants are divided into four groups: two groups receive 8 weekly sessions of radiofrequency therapy, one group receives 8 weekly sessions of myofascial manual therapy, and the final group receives no treatment but is monitored. The radiofrequency groups are further split into an active treatment group and a sham (placebo) control group, both double-blinded. Besides the sessions, all groups using therapy perform daily Thiele massage at home. Each session lasts about 20 minutes. During the study, researchers assess pain levels through muscular evaluation using a verbal numeric scale at the start and after 8 weeks of treatment. Additional measures include sexual function, pain catastrophizing, quality of life, anxiety, depression, central sensitization, and other pelvic floor symptoms. These assessments help monitor the effects of the therapies and overall well-being. The study involves close monitoring and evaluation over an 8-week period.
CONDITIONS
Brief 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 aged 18 years or older
- 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
- Agreed to sign the informed consent form
You will not qualify if you...
- Pregnant women
- Women who gave birth within the last year
- History of vulvovaginal pathology
- Contraindications for radiofrequency use such as metal implants or active infection
- History of pelvic cancer or treatments including chemotherapy, radiotherapy, or brachytherapy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive weekly sessions of either radiofrequency therapy or myofascial manual therapy at home, or no treatment if assigned to the waiting list.
8 weekly treatment sessions
Duration - 6 months
Participants in the no treatment group are monitored for symptoms for 6 months.
1 follow-up visit after 6 months
Trial Site Locations
Total: 1 location
1
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
Research Team
C
Carla Box, PT, MSc
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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