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

Effect of Radiofrequency in Women With Chronic Pelvic Pain With an Associated Myofascial Syndrome Versus Myofascial Therapy and no Treatment: a Randomized Clinical Trial

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Pelvic Pain
• Intervention / Treatment: Device: Radiofrequency therapy; Other: myofascial manual therapy

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carla Box, PT, MSc; Phone Number: +34932275300; Email: cebox@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clinic de Barcelona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ON RF; 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; 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
Sham Comparator: OFF RF; 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; 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
Active Comparator: MYOFASCIAL MANUAL THERAPY; 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; Myofascial manual therapy sessions including the abdominal region, the vulva and pelvic floor tissue and Thiele massage done daily by the patient at home
No Intervention: NO TREATMENT; Patients in waiting list, pending treatment will not receive treatment but symptoms will be monitored after 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Level	Pain Level using the Verbal Numeric Scale (VNS). The scores go from 0 (lowest) to 10 (highest)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual function	Sexual function using the female sexual function index. The score ranges from 2 (severe) to 36 (no sexual disfunction)	8 weeks
Quality of life (QoL)	Quality of life using the EuroQuality of life-5Dimensions (EQ5D. Ranges from -0.59 (lowest QoL) and 1 (highest)	8 weeks
Pain catastrophizing	Using the pain catastrophizing scale (PCS).Ranges from 0 to 52 where higher scores indicate a greater degree of pain catastrophizing. A total score of >30 represents a clinically significant level of pain catastrophization	8 weeks
Anxiety and depression	Anxiety and depression using the Hospital Anxiety and depression Scale (HADS). Generally, scores of 0 to 7 on this questionnaire are considered to be normal, scores of 8 to 10 indicate mild symptoms, 11 to 14 indicate moderate symptoms, and 15 to 21 indicate severe symptoms	8 weeks
Central sensitization	Using the central sensitization index (CSI). Ranging from 0-100, >40 is the cutoff for pain sensitization	8 weeks

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Estimated): June 10, 2025
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: manual therapy; radiofrequency; chronic pelvic pain; myofascial syndrome
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain
• Other Study ID Numbers: HCB/2021/0313 (Other Identifier: Ethics Comittee - Hospital Clinic de Barcelona)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No