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

Not Applicable

Recruiting

• Conditions: Chronic Pelvic Pain

• Registration Number: NCT06908200
• Lead Sponsor: Hospital Clinic of Barcelona

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-10
• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-06-10
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Level	8 weeks	Pain Level using the Verbal Numeric Scale (VNS). The scores go from 0 (lowest) to 10 (highest)

Secondary Outcome Measures

Name	Time	Method
Sexual function	8 weeks	Sexual function using the female sexual function index. The score ranges from 2 (severe) to 36 (no sexual disfunction)
Quality of life (QoL)	8 weeks	Quality of life using the EuroQuality of life-5Dimensions (EQ5D. Ranges from -0.59 (lowest QoL) and 1 (highest)
Pain catastrophizing	8 weeks	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
Anxiety and depression	8 weeks	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
Central sensitization	8 weeks	Using the central sensitization index (CSI). Ranging from 0-100, \>40 is the cutoff for pain sensitization

Trial Locations

Locations (1)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain