Physiotherapy Intervention in Climacteric Women With Dyspareunia

Sponsor
Hospital de Clinicas de Porto Alegre (Other)
Overall Status
Completed
CT.gov ID
NCT02804048
Collaborator
(none)
42
1
2
46
0.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

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 Design

Study Type:
Interventional
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 :
Dec 1, 2012
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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]

  2. To evaluate depression [To evaluate depression, using Beck Scale, in baseline and after four weeks of intervention]

  3. To evaluate sexual function [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 [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 [To evaluate the pelvic floor muscle function, using PERFECT Scale in baseline and after four weeks of intervention]

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinical Research Center of HCPA Porto Alegre RS Brazil 900035-903

Sponsors and Collaborators

  • Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Maria Celeste Wender, PhD, Hospital de Clínicas de Porto Alegre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT02804048
Other Study ID Numbers:
  • 13-0307
First Posted:
Jun 17, 2016
Last Update Posted:
Oct 5, 2016
Last Verified:
Oct 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2016