Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06908200

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Pelvic Pain

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Pain Level

    Time frame: 8 weeks

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

Secondary outcomes

  1. Sexual function

    Time frame: 8 weeks

    Sexual function using the female sexual function index. The score ranges from 2 (severe) to 36 (no sexual disfunction)

  2. Quality of life (QoL)

    Time frame: 8 weeks

    Quality of life using the EuroQuality of life-5Dimensions (EQ5D. Ranges from -0.59 (lowest QoL) and 1 (highest)

  3. Pain catastrophizing

    Time frame: 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

  4. Anxiety and depression

    Time frame: 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

  5. Central sensitization

    Time frame: 8 weeks

    Using the central sensitization index (CSI). Ranging from 0-100, >40 is the cutoff for pain sensitization

Study contacts

Contact information is provided by the study sponsor or research team.

Carla Box, PT, MSc

CONTACT

[email protected]

+34932275300

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.