Physiotherapy Intervention in Climacteric Women With Dyspareunia

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

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.

Study Overview

• Status: Completed
• Conditions: Dyspareunia
• Intervention / Treatment: 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; Other: superficial heat low back

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 900035-903
      • Clinical Research Center of HCPA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Maria Celeste Wender, PhD, Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (Estimate): June 17, 2016

Study Record Updates

• Last Update Posted (Estimate): October 5, 2016
• Last Update Submitted That Met QC Criteria: October 4, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Women; Dyspareunia; Pelvic floor muscles
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Dyspareunia
• Other Study ID Numbers: 13-0307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided