Physiotherapy Intervention in Climacteric Women With Dyspareunia

Dyspareunia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804048
• Other study ID #: 13-0307
• Status: Completed
• Phase: N/A
• First received: February 12, 2016
• Last updated: October 4, 2016
• Start date: December 2012
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspareunia

Intervention

Other:
• superficial heat pelvic floor muscle
Superficial heat application in the pelvic floor muscle
• superficial heat low back
Superficial heat application in the low back
• Pelvic Floor Muscle Training
Pelvic floor muscle training exercises
• Manual therapy in iliopsoas, diaphragm and piriformis
Manual therapy in iliopsoas, diaphragm and piriformis for 10 minutes
• Intra Vaginal Manual therapy
Intra Vaginal Manual therapy in the pelvic floor muscles
• Electromyographic biofeedback
Electromyographic biofeedback in the pelvic floor muscles

Locations

Country	Name	City	State
Brazil	Clinical Research Center of HCPA	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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	Yes
Secondary	To evaluate depression		To evaluate depression, using Beck Scale, in baseline and after four weeks of intervention	Yes
Secondary	To evaluate sexual function		To evaluate sexual function, using Female Sexual Function Index, in baseline and after four weeks of intervention	Yes
Secondary	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	Yes
Secondary	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	Yes