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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.
Search location: Menopause and Sexuality Clinic of the department of obstetrics and Gynecology and Clinical Research Center, Hospital de ClÃnicas 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic Floor Muscle Training | Experimental | 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. |
|
| Low back | Placebo Comparator | superficial heat low back Manual therapy in piriform, lumbar, iliopsoas and diaphragm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| superficial heat pelvic floor muscle | Other | Superficial heat application in the pelvic floor muscle |
|
| 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. |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Celeste Wender, PhD | Hospital de ClÃnicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of HCPA | Porto Alegre | Rio Grande do Sul | 900035-903 | Brazil |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 11, 2019 | |
| Reset | Oct 31, 2019 |
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| superficial heat low back | Other | Superficial heat application in the low back |
|
| Pelvic Floor Muscle Training | Other | Pelvic floor muscle training exercises |
|
| Manual therapy in iliopsoas, diaphragm and piriformis | Other | Manual therapy in iliopsoas, diaphragm and piriformis for 10 minutes |
|
| Intra Vaginal Manual therapy | Other | Intra Vaginal Manual therapy in the pelvic floor muscles |
|
| Electromyographic biofeedback | Other | Electromyographic biofeedback in the pelvic floor muscles |
|
| 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 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 11, 2019 | Oct 31, 2019 |
| ID | Term |
|---|---|
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D003274 | Contraceptive Devices, Female |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
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