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Hyperthermy Endocavitary Treatment in Pelvic Pain

Primary Purpose

Pelvic Pain

Status
Unknown status
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Hyperthermy treatment with MJS electrode
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Pain focused on measuring chronic pelvic pain, trigger points, hiperthermy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Marta Sainz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Hyperthermy treatment with MJS electrode

CONTROL

Arm Description

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

No intervention with radiofrequency treatment, only evaluation to usual drug treatment

Outcomes

Primary Outcome Measures

NIH-CPSI questionnaire
questions for pelvic pain evaluation

Secondary Outcome Measures

pain measure questionnaire

Full Information

First Posted
July 6, 2016
Last Updated
December 2, 2016
Sponsor
Universidad Rey Juan Carlos
Collaborators
Hospital Universitario Virgen de la Victoria
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1. Study Identification

Unique Protocol Identification Number
NCT02837588
Brief Title
Hyperthermy Endocavitary Treatment in Pelvic Pain
Official Title
Endocavitary Radiofrequency Treatment in Patients Who Present With Chronic Pelvic Pain Compared to Usual Drug Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos
Collaborators
Hospital Universitario Virgen de la Victoria

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain
Keywords
chronic pelvic pain, trigger points, hiperthermy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperthermy treatment with MJS electrode
Arm Type
Active Comparator
Arm Description
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
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
No intervention with radiofrequency treatment, only evaluation to usual drug treatment
Intervention Type
Device
Intervention Name(s)
Hyperthermy treatment with MJS electrode
Intervention Description
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
Primary Outcome Measure Information:
Title
NIH-CPSI questionnaire
Description
questions for pelvic pain evaluation
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
pain measure questionnaire
Time Frame
four weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina Walker, Dr
Organizational Affiliation
Universitat Central de Catalunya
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marta Losa, Dr
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Study Director
Facility Information:
Facility Name
Marta Sainz
City
Malaga
State/Province
Málaga
ZIP/Postal Code
29018
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
It's approved from 2015 May to 2016 December, when the investigators have to report clinical trial conclusions

Learn more about this trial

Hyperthermy Endocavitary Treatment in Pelvic Pain

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