Hyperthermy Endocavitary Treatment in Pelvic Pain

Universidad Rey Juan Carlos

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Pelvic Pain

Treatments: Device: Hyperthermy treatment with MJS electrode

Study type: Interventional

Funder types: Other

Identifiers

NCT02837588

Hyperthermy pelvic floor

Details and patient eligibility

About

• 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

Full 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

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Hyperthermy treatment with MJS electrode

Active Comparator group

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

Treatment:

Device: Hyperthermy treatment with MJS electrode

CONTROL

No Intervention group

Description:

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