Physiotherapy Intervention in Climacteric Women With Dyspareunia

Study Overview
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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.

Official Title
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Physiotherapy Intervention in Climacteric Women With Dyspareunia: A Randomized Controlled Trial

Conditions
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Dyspareunia

Intervention / Treatment
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* Other: superficial heat pelvic floor muscle
* Other: superficial heat low back
* Other: Pelvic Floor Muscle Training
* Other: Manual therapy in iliopsoas, diaphragm and piriformis
* Other: Intra Vaginal Manual therapy
* Other: Electromyographic biofeedback


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pelvic Floor Muscle Training<br>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. | Other: superficial heat pelvic floor muscle<br>* Superficial heat application in the pelvic floor muscle<br>Other: Pelvic Floor Muscle Training<br>* Pelvic floor muscle training exercises<br>Other: Manual therapy in iliopsoas, diaphragm and piriformis<br>* Manual therapy in iliopsoas, diaphragm and piriformis for 10 minutes<br>Other: Intra Vaginal Manual therapy<br>* Intra Vaginal Manual therapy in the pelvic floor muscles<br>Other: Electromyographic biofeedback<br>* Electromyographic biofeedback in the pelvic floor muscles<br>|
| Placebo Comparator: Low back<br>superficial heat low back Manual therapy in piriform, lumbar, iliopsoas and diaphragm. | Other: superficial heat low back<br>* Superficial heat application in the low back<br>Other: Manual therapy in iliopsoas, diaphragm and piriformis<br>* Manual therapy in iliopsoas, diaphragm and piriformis for 10 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effectiveness of physiotherapy techniques in pain improvement using visual analog scale pain | To evaluate the effectiveness of physiotherapy techniques using the analog pain scale. | Seven meetings, twice a week, in which the first is the initial assessment and the seventh is the final evaluation totaling a maximum of one month treatment for each patient. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the quality of life |  | To evaluate the quality of life, using Cervantes Scale in climateric women in baseline and after four weeks of intervention | 
| To evaluate depression |  | To evaluate depression, using Beck Scale, in baseline and after four weeks of intervention | 
| To evaluate sexual function |  | To evaluate sexual function, using Female Sexual Function Index, in baseline and after four weeks of intervention | 
| To evaluate electrical activity of the pelvic floor muscles |  | To evaluate electrical activity of the pelvic floor muscles, using Electromyographic biofeedback , in baseline and after four weeks of intervention | 
| To evaluate the pelvic floor muscle function |  | To evaluate the pelvic floor muscle function, using PERFECT Scale in baseline and after four weeks of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyspareunia, Pelvic floor muscles, Women