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Physiotherapy Intervention in Climacteric Women With Dyspareunia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804048
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Dyspareunia 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Physiotherapy Intervention in Climacteric Women With Dyspareunia: A Randomized Controlled Trial
Study Start Date : December 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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: superficial heat low back
Superficial heat application in the low back

Other: Manual therapy in iliopsoas, diaphragm and piriformis
Manual therapy in iliopsoas, diaphragm and piriformis for 10 minutes




Primary Outcome Measures :
  1. To evaluate the effectiveness of physiotherapy techniques in pain improvement using visual analog scale pain [ 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. ]
    To evaluate the effectiveness of physiotherapy techniques using the analog pain scale.


Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate depression [ Time Frame: To evaluate depression, using Beck Scale, in baseline and after four weeks of intervention ]
  3. To evaluate sexual function [ Time Frame: To evaluate sexual function, using Female Sexual Function Index, in baseline and after four weeks of intervention ]
  4. 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 ]
  5. 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 ]


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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804048


Locations
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Brazil
Clinical Research Center of HCPA
Porto Alegre, RS, Brazil, 900035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Maria Celeste Wender, PhD Hospital de Clínicas de Porto Alegre
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02804048    
Other Study ID Numbers: 13-0307
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
Dyspareunia
Pelvic floor muscles
Women
Additional relevant MeSH terms:
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Dyspareunia
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders