Overview

This trial is active, not recruiting.

Condition pelvic pain
Treatment hyperthermy treatment with mjs electrode
Phase phase 1/phase 2
Sponsor Universidad Rey Juan Carlos
Collaborator Hospital Universitario Virgen de la Victoria
Start date August 2015
End date July 2016
Trial size 60 participants
Trial identifier NCT02837588, Hyperthermy pelvic floor

Summary

- Treatment at pelvic floor with hyperactivity with hyperthermy electrode MJS

- MJS electrode is effective for transvaginal treatment at pelvic pain patients

- Hyperthermy treatment with MJS electrode is more effective to usual drugs treatment

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose treatment
Arm
(Active Comparator)
30 patients who are diagnosed with myofascial syndrome by gyneacologist or urologist goes to Pelvic Floor Physiotherapist for 4 session with hyperthermy treatment with MJS electrode at pelvic floor trigger points
hyperthermy treatment with mjs electrode
30 patients who are diagnosed Pelvic pain with myofascial syndrome by gyneacologist or urologist goes to Pelvic Floor Physiotherapist for 4 session with hyperthermy treatment with MJS electrode at pelvic floor trigger points
(No Intervention)
No intervention with radiofrequency treatment, only evaluation to usual drug treatment

Primary Outcomes

Measure
NIH-CPSI questionnaire
time frame: four weeks

Secondary Outcomes

Measure
pain measure questionnaire
time frame: four weeks

Eligibility Criteria

Female participants from 18 years up to 80 years old.

Inclusion Criteria: - Women with chronic pelvic pain Exclusion Criteria: - chronic pelvic pain or neurological degenerative etiology - Presence of pathology or infectious processes genitourinary level - possibility of pregnancy or lactating. - Lack of informed consent, mental disorders, dementia, dependent people who need tutor.

Additional Information

Official title Endocavitary Radiofrequency Treatment in Patients Who Present With Chronic Pelvic Pain Compared to Usual Drug Therapy
Description This study analyzed the evolution of chronic pelvic pain, defined by the different map of myofascial trigger points assets presents the patient with medical treatment compared to treatment with radiofrequency endocavitary electrode MJS. The initial evaluator analyzed by the NIH-CPSI Scale questionnaire and symptoms of chronic pelvic pain Stanford Protocol for female or male quality of life of the patient before the doctor or radio frequency and a month since treatment. the patient to the Principal Investigator, specialist physiotherapist, who appreciates tenderness the presence of a taut band with a map of pain in endopelvic and exopelvic muscles, determining the activation of myofascial trigger points in each is derived. The Principal Investigator proceeds to address each active myofascial trigger points with the MJS electrode four 20-minute sessions twice a week. The MJS has a curved end pressure which favors the compression point plus the location and accurate approach Radiofrequency pathological point as outstanding feature. The high specificity of myofascial treatment offered by the MJS electrode involves no danger, besides having the computer screen conductivity meter and a temperature sensor on the head to control both parameters in real time during the treatment session
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Universidad Rey Juan Carlos.