Hyperthermy Endocavitary Treatment in Pelvic Pain

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

• 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

Study Overview

• Status: Unknown
• Conditions: Pelvic Pain
• Intervention / Treatment: Device: Hyperthermy treatment with MJS electrode

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Málaga
    • Malaga, Málaga, Spain, 29018
      • Marta Sainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIH-CPSI questionnaire	questions for pelvic pain evaluation	four weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
pain measure questionnaire	four weeks

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos
• Collaborators: Hospital Universitario Virgen de la Victoria
• Investigators: Study Director: Carolina Walker, Dr, Universitat Central de Catalunya; Study Director: Marta Losa, Dr, Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimate): July 19, 2016

Study Record Updates

• Last Update Posted (Estimate): December 5, 2016
• Last Update Submitted That Met QC Criteria: December 2, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: trigger points; chronic pelvic pain; hiperthermy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pelvic Pain
• Other Study ID Numbers: Hyperthermy pelvic floor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: It's approved from 2015 May to 2016 December, when the investigators have to report clinical trial conclusions