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Clinical Trials/NCT02837588
NCT02837588
Unknown
Phase 1

Endocavitary Radiofrequency Treatment in Patients Who Present With Chronic Pelvic Pain Compared to Usual Drug Therapy

Universidad Rey Juan Carlos1 site in 1 country60 target enrollmentAugust 2015
ConditionsPelvic Pain

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Pelvic Pain
Sponsor
Universidad Rey Juan Carlos
Enrollment
60
Locations
1
Primary Endpoint
NIH-CPSI questionnaire
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marta Jerez Sainz

Director, coordinator of Pelvic floor department, Principal Investigator, Clinical Professor

Universidad Rey Juan Carlos

Eligibility Criteria

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.

Outcomes

Primary Outcomes

NIH-CPSI questionnaire

Time Frame: four weeks

questions for pelvic pain evaluation

Secondary Outcomes

  • pain measure questionnaire(four weeks)

Study Sites (1)

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