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

NCT06908200 | Recruiting

• 1 other identifier: HCB/2021/0313
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Pelvic Pain

Keywords

chronic pelvic pain; myofascial syndrome; radiofrequency; manual therapy

Outcome Measures

Primary Outcomes (1)

• Pain Level

  Pain Level using the Verbal Numeric Scale (VNS). The scores go from 0 (lowest) to 10 (highest)

  8 weeks

Secondary Outcomes (5)

• Sexual function

  8 weeks

• Quality of life (QoL)

  8 weeks

• Pain catastrophizing

  8 weeks

• Anxiety and depression

  8 weeks

• Central sensitization

  8 weeks

Study Arms (4)

ON RF

ACTIVE COMPARATOR

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.

Device: Radiofrequency therapy

OFF RF

SHAM COMPARATOR

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.

Device: Radiofrequency therapy

MYOFASCIAL MANUAL THERAPY

ACTIVE COMPARATOR

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.

Other: myofascial manual therapy

NO TREATMENT

NO INTERVENTION

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

Interventions

Radiofrequency therapy DEVICE

Radiofrequency or myofascial manual therapy sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home

OFF RF; ON RF

myofascial manual therapy OTHER

Myofascial manual therapy sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home

MYOFASCIAL MANUAL THERAPY

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: WOMEN PRESENTING CHRONIC PELVIC PAIN
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Interventions

Radiofrequency Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Carla Box, PT, MSc

CONTACT

+34932275300; cebox@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 3, 2025
• Study Start: May 10, 2022
• Primary Completion: June 10, 2025
• Study Completion: June 15, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)