MedDataX Logo

Hyperthermy Endocavitary Treatment in Pelvic Pain

NCT ID: NCT02837588

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

* 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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

chronic pelvic pain trigger points hiperthermy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Hyperthermy treatment with MJS electrode

Intervention Type DEVICE

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

CONTROL

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Universitario Virgen de la Victoria

OTHER

Sponsor Role collaborator

Universidad Rey Juan Carlos

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Marta Jerez Sainz

Director, coordinator of Pelvic floor department, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Carolina Walker, Dr

Role: STUDY_DIRECTOR

Universitat Central de Catalunya

Marta Losa, Dr

Role: STUDY_DIRECTOR

Universidad Rey Juan Carlos

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Marta Sainz

Málaga, Málaga, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Hyperthermy pelvic floor

Identifier Type: -

Identifier Source: org_study_id