Hyperthermy Endocavitary Treatment in Pelvic Pain

Pelvic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02837588
• Other study ID #: Hyperthermy pelvic floor
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: July 6, 2016
• Last updated: December 2, 2016
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministerio de Sanidad, Servicios Sociales e IgualdadSpain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Pain

Intervention

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

Locations

Country	Name	City	State
Spain	Marta Sainz	Malaga	Málaga

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos	Hospital Universitario Virgen de la Victoria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIH-CPSI questionnaire	questions for pelvic pain evaluation	four weeks	Yes
Secondary	pain measure questionnaire		four weeks	Yes