Effect of Radiofrequency on Chronic Pelvic Pain in Women
Effect of Radiofrequency in Women With Chronic Pelvic Pain With an Associated Myofascial Syndrome Versus Myofascial Therapy and no Treatment: a Randomized Clinical Trial
This study is testing if radiofrequency therapy can help women with chronic pelvic pain feel better compared to myofascial release therapy or no treatment at all.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06908200 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of radiofrequency therapy compared to myofascial release therapy and no treatment in women suffering from chronic pelvic pain associated with myofascial syndrome. Participants are randomly assigned to receive either radiofrequency sessions, myofascial therapy, or no treatment at all, with the radiofrequency groups being double-blinded. The study aims to assess pain levels before and after the interventions using a standardized pain scale. The trial is conducted at the Hospital Clinic de Barcelona over an 8-week period.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with chronic pelvic pain lasting at least 6 months and diagnosed with myofascial syndrome.
Not a fit: Patients who are pregnant, postpartum within the last year, or have contraindications for radiofrequency treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for women suffering from chronic pelvic pain.
How similar studies have performed: Other studies have shown promising results with radiofrequency therapy for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Barcelona
- Hospital Clinic de Barcelona — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Carla Box, PT, MSc
- Email: cebox@clinic.cat
- Phone: +34932275300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.