Physiotherapy Intervention in Climacteric Women With Dyspareunia

NCT ID: NCT02804048

Last Updated: 2016-10-05

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-10-31

Brief Summary

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Aim: To evaluate the effectiveness of physical therapy intervention techniques in the improvement of dyspareunia in climacteric women.

Study design: This is a randomized controlled trial.

Detailed Description

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Search location: Menopause and Sexuality Clinic of the department of obstetrics and Gynecology and Clinical Research Center, Hospital de Clínicas de Porto Alegre (HCPA).

Patients or participants: The recruited patients may not be vaginal atrophy (cytology-hormone test) and must provide the diagnosis of dyspareunia for more than six months being confirmed by one of the investigators through the pain score above grade 3 (visual analog pain scale) visual inspection, palpation and a questionnaire about the duration and location of pain.

Intervention and measures: consist of evaluation of the pelvic floor muscles (Oxford Scale and Perfect), myoelectric assessment (Electromyography), quality of life (Cervantes Scale), sexual function (FSFI), level of depression (Beck Scale) and pain (visual analog pain scale) before and after physical therapy intervention.

Expected results: To estimate the effectiveness of pelvic floor training techniques with physical therapy in women with dyspareunia.

Conditions

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Dyspareunia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Pelvic Floor Muscle Training

superficial heat pelvic floor muscle intra vaginal manual therapy. PERFECT scale is applied in 5 sessions and based on the result of each assessment is performed the treatment plan with exercises of the pelvic floor muscles.

It is performed manual therapy in iliopsoas, diaphragm and piriformis. From the fourth session, initiate treatment with electromyographic biofeedback based on the result of PERFECT scale.

Group Type EXPERIMENTAL

superficial heat pelvic floor muscle

Intervention Type OTHER

Superficial heat application in the pelvic floor muscle

Pelvic Floor Muscle Training

Intervention Type OTHER

Pelvic floor muscle training exercises

Manual therapy in iliopsoas, diaphragm and piriformis

Intervention Type OTHER

Manual therapy in iliopsoas, diaphragm and piriformis for 10 minutes

Intra Vaginal Manual therapy

Intervention Type OTHER

Intra Vaginal Manual therapy in the pelvic floor muscles

Electromyographic biofeedback

Intervention Type OTHER

Electromyographic biofeedback in the pelvic floor muscles

Low back

superficial heat low back Manual therapy in piriform, lumbar, iliopsoas and diaphragm.

Group Type PLACEBO_COMPARATOR

superficial heat low back

Intervention Type OTHER

Superficial heat application in the low back

Manual therapy in iliopsoas, diaphragm and piriformis

Intervention Type OTHER

Manual therapy in iliopsoas, diaphragm and piriformis for 10 minutes

Interventions

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superficial heat pelvic floor muscle

Superficial heat application in the pelvic floor muscle

Intervention Type OTHER

superficial heat low back

Superficial heat application in the low back

Intervention Type OTHER

Pelvic Floor Muscle Training

Pelvic floor muscle training exercises

Intervention Type OTHER

Manual therapy in iliopsoas, diaphragm and piriformis

Manual therapy in iliopsoas, diaphragm and piriformis for 10 minutes

Intervention Type OTHER

Intra Vaginal Manual therapy

Intra Vaginal Manual therapy in the pelvic floor muscles

Intervention Type OTHER

Electromyographic biofeedback

Electromyographic biofeedback in the pelvic floor muscles

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* dyspareunia complaint for at least six months
* visual analog scale of pain above 3
* trophic vagina

Exclusion Criteria

* vaginal atrophy
* neurological disorders
* lack of cognition and understanding
* urinary tract infection and / or genital infections
* prolapse grade 2 and 3
* severe systemic disease
* performing physical therapy
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Celeste Wender, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

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Clinical Research Center of HCPA

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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13-0307

Identifier Type: -

Identifier Source: org_study_id

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