Hyperthermy Endocavitary Treatment in Pelvic Pain

Phase 1

• Conditions: Pelvic Pain
• Interventions: Device: Hyperthermy treatment with MJS electrode

• Registration Number: NCT02837588
• Lead Sponsor: Universidad Rey Juan Carlos

Brief 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

Detailed 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

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-15
• Study First Posted: 2016-07-19
• Status Verified: 2016-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperthermy treatment with MJS electrode	Hyperthermy treatment with MJS electrode	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

Primary Outcome Measures

Name	Time	Method
NIH-CPSI questionnaire	four weeks	questions for pelvic pain evaluation

Secondary Outcome Measures

Name	Time	Method
pain measure questionnaire	four weeks

Trial Locations

Locations (1)

Marta Sainz; 🇪🇸 Malaga, Málaga, Spain