Physiotherapy Intervention in Climacteric Women With Dyspareunia

Not Applicable

Completed

• Conditions: Dyspareunia
• Interventions: Other: superficial heat low back; Other: superficial heat pelvic floor muscle; Other: Pelvic Floor Muscle Training; Other: Manual therapy in iliopsoas, diaphragm and piriformis; Other: Intra Vaginal Manual therapy; Other: Electromyographic biofeedback

• Registration Number: NCT02804048
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Primary Completion: 2016-09
• Status Verified: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pelvic Floor Muscle Training	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.
Pelvic Floor Muscle Training	Intra Vaginal Manual therapy	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.
Pelvic Floor Muscle Training	Manual therapy in iliopsoas, diaphragm and piriformis	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.
Low back	superficial heat low back	superficial heat low back Manual therapy in piriform, lumbar, iliopsoas and diaphragm.
Pelvic Floor Muscle Training	superficial heat pelvic floor muscle	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.
Pelvic Floor Muscle Training	Electromyographic biofeedback	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.
Low back	Manual therapy in iliopsoas, diaphragm and piriformis	superficial heat low back Manual therapy in piriform, lumbar, iliopsoas and diaphragm.

Primary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of physiotherapy techniques in pain improvement using visual analog scale pain	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.	To evaluate the effectiveness of physiotherapy techniques using the analog pain scale.

Secondary Outcome Measures

Name	Time	Method
To evaluate depression	To evaluate depression, using Beck Scale, 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
To evaluate sexual function	To evaluate sexual function, using Female Sexual Function Index, in baseline and after four weeks of intervention
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 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

Trial Locations

Locations (1)

Clinical Research Center of HCPA; 🇧🇷 Porto Alegre, RS, Brazil