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

Hospital Clinic of Barcelona

Status: Enrolling

Conditions: Chronic Pelvic Pain

Treatments: Device: Radiofrequency therapy; Other: myofascial manual therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06908200

HCB/2021/0313 (Other Identifier)

Details and patient eligibility

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).

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups

ON RF

Active Comparator group

Description:

Application of the technique in the intervention group (activated resistive capacitive monopolar radiofrequency therapy): the intervention group 1 will receive treatment with activated RF, with the electrode at a medium intensity for 20 minutes per session during a total of 8 sessions, held weekly.

Treatment:

Device: Radiofrequency therapy

OFF RF

Sham Comparator group

Description:

Application of the technique in the intervention group (activated resistive capacitive monopolar radiofrequency therapy): the CONTROL group 2 will receive treatment with activated RF, with the electrode for 20 minutes per session during a total of 8 sessions, held weekly.

Treatment:

Device: Radiofrequency therapy

MYOFASCIAL MANUAL THERAPY

Active Comparator group

Description:

Application of the technique in the intervention group 2 (MYOFASCIAL MANUAL THERAPY): the intervention group 2 will receive treatment for 20 minutes per session during a total of 8 sessions, held weekly.

Treatment:

Other: myofascial manual therapy

NO TREATMENT

No Intervention group

Description:

Patients in waiting list, pending treatment will not receive treatment but symptoms will be monitored after 6 months