Clinical trial NCT06908200: Effect of Radiofrequency in Women With Chronic Pelvic Pain With an Associated Myofascial Syndrome Versus Myofascial Therapy and no Treatment
Official title: Effect of Radiofrequency in Women With Chronic Pelvic Pain With an Associated Myofascial Syndrome Versus Myofascial Therapy and no Treatment: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pelvic Pain
Keywords: chronic pelvic pain
myofascial syndrome
radiofrequency
manual therapy
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Pain Level
timeFrame: 8 weeks
Secondary outcomes:
measure: Sexual function
timeFrame: 8 weeks
measure: Quality of life (QoL)
timeFrame: 8 weeks
measure: Pain catastrophizing
timeFrame: 8 weeks
measure: Anxiety and depression
timeFrame: 8 weeks
measure: Central sensitization
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
References: