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Physiotherapy Intervention in Climacteric Women With Dyspareunia

Primary Purpose

Dyspareunia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
superficial heat pelvic floor muscle
superficial heat low back
Pelvic Floor Muscle Training
Manual therapy in iliopsoas, diaphragm and piriformis
Intra Vaginal Manual therapy
Electromyographic biofeedback
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspareunia focused on measuring Dyspareunia, Pelvic floor muscles, Women

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Center of HCPA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pelvic Floor Muscle Training

Low back

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To evaluate the quality of life
To evaluate depression
To evaluate sexual function
To evaluate electrical activity of the pelvic floor muscles
To evaluate the pelvic floor muscle function

Full Information

First Posted
February 12, 2016
Last Updated
October 4, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02804048
Brief Title
Physiotherapy Intervention in Climacteric Women With Dyspareunia
Official Title
Physiotherapy Intervention in Climacteric Women With Dyspareunia: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspareunia
Keywords
Dyspareunia, Pelvic floor muscles, Women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic Floor Muscle Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Low back
Arm Type
Placebo Comparator
Arm Description
superficial heat low back Manual therapy in piriform, lumbar, iliopsoas and diaphragm.
Intervention Type
Other
Intervention Name(s)
superficial heat pelvic floor muscle
Intervention Description
Superficial heat application in the pelvic floor muscle
Intervention Type
Other
Intervention Name(s)
superficial heat low back
Intervention Description
Superficial heat application in the low back
Intervention Type
Other
Intervention Name(s)
Pelvic Floor Muscle Training
Intervention Description
Pelvic floor muscle training exercises
Intervention Type
Other
Intervention Name(s)
Manual therapy in iliopsoas, diaphragm and piriformis
Intervention Description
Manual therapy in iliopsoas, diaphragm and piriformis for 10 minutes
Intervention Type
Other
Intervention Name(s)
Intra Vaginal Manual therapy
Intervention Description
Intra Vaginal Manual therapy in the pelvic floor muscles
Intervention Type
Other
Intervention Name(s)
Electromyographic biofeedback
Intervention Description
Electromyographic biofeedback in the pelvic floor muscles
Primary Outcome Measure Information:
Title
To evaluate the effectiveness of physiotherapy techniques in pain improvement using visual analog scale pain
Description
To evaluate the effectiveness of physiotherapy techniques using the analog pain scale.
Time Frame
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 Measure Information:
Title
To evaluate the quality of life
Time Frame
To evaluate the quality of life, using Cervantes Scale in climateric women in baseline and after four weeks of intervention
Title
To evaluate depression
Time Frame
To evaluate depression, using Beck Scale, in baseline and after four weeks of intervention
Title
To evaluate sexual function
Time Frame
To evaluate sexual function, using Female Sexual Function Index, in baseline and after four weeks of intervention
Title
To evaluate electrical activity of the pelvic floor muscles
Time Frame
To evaluate electrical activity of the pelvic floor muscles, using Electromyographic biofeedback , in baseline and after four weeks of intervention
Title
To evaluate the pelvic floor muscle function
Time Frame
To evaluate the pelvic floor muscle function, using PERFECT Scale in baseline and after four weeks of intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Celeste Wender, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Center of HCPA
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
900035-903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Physiotherapy Intervention in Climacteric Women With Dyspareunia

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