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Hyperthermy Endocavitary Treatment in Pelvic Pain

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ClinicalTrials.gov Identifier: NCT02837588
Recruitment Status : Unknown
Verified December 2016 by Marta Jerez Sainz, Universidad Rey Juan Carlos.
Recruitment status was:  Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : December 5, 2016
Sponsor:
Collaborator:
Hospital Universitario Virgen de la Victoria
Information provided by (Responsible Party):
Marta Jerez Sainz, 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

Condition or disease Intervention/treatment Phase
Pelvic Pain Device: Hyperthermy treatment with MJS electrode Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Endocavitary Radiofrequency Treatment in Patients Who Present With Chronic Pelvic Pain Compared to Usual Drug Therapy
Study Start Date : August 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arm Intervention/treatment
Active Comparator: 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
Device: 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: CONTROL
No intervention with radiofrequency treatment, only evaluation to usual drug treatment



Primary Outcome Measures :
  1. NIH-CPSI questionnaire [ Time Frame: four weeks ]
    questions for pelvic pain evaluation


Secondary Outcome Measures :
  1. pain measure questionnaire [ Time Frame: four weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837588


Locations
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Spain
Marta Sainz
Malaga, Málaga, Spain, 29018
Sponsors and Collaborators
Universidad Rey Juan Carlos
Hospital Universitario Virgen de la Victoria
Investigators
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Study Director: Carolina Walker, Dr Universitat Central de Catalunya
Study Director: Marta Losa, Dr Universidad Rey Juan Carlos
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Responsible Party: Marta Jerez Sainz, Director, coordinator of Pelvic floor department, Principal Investigator, Clinical Professor, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT02837588    
Other Study ID Numbers: Hyperthermy pelvic floor
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: It's approved from 2015 May to 2016 December, when the investigators have to report clinical trial conclusions
Keywords provided by Marta Jerez Sainz, Universidad Rey Juan Carlos:
chronic pelvic pain
trigger points
hiperthermy
Additional relevant MeSH terms:
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Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms