Hyperthermy Endocavitary Treatment in Pelvic Pain | NCT02837588

Studies
Hyperthermy Endocavitary Treatment in Pelvic Pain

NCT02837588

Sponsor

Universidad Rey Juan Carlos

Status

Unknown status

Last Update Posted

Dec 5, 2016Estimated

Enrollment

60Estimated

Phase

Phase 1Phase 2

Conditions

Pelvic Pain

Interventions

Hyperthermy treatment with MJS electrode

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Dec 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Jul 6, 2016

First Submission Date that Met QC Criteria

Jul 15, 2016

First Posted Date

Jul 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2016

Last Update Posted Date

Dec 5, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marta Jerez Sainz, Director, coordinator of Pelvic floor department, Principal Investigator, Clinical Professor, Universidad Rey Juan CarlosPrincipal Investigator

Lead Sponsor

Universidad Rey Juan CarlosOTHER

Collaborators

Name	Class
Hospital Universitario Virgen de la Victoria	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyperthermy treatment with MJS electrode	Active Comparator	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
CONTROL	No Intervention	No intervention with radiofrequency treatment, only evaluation to usual drug treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyperthermy treatment with MJS electrode	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
pain measure questionnaire		four weeks

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carolina Walker, Dr	Universitat Central de Catalunya	Study Director
Marta Losa, Dr	Universidad Rey Juan Carlos	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marta Sainz		Málaga	Málaga	29018	Spain

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

It's approved from 2015 May to 2016 December, when the investigators have to report clinical trial conclusions

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017699	Pelvic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided