Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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REBEC |
Last refreshed on:
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29 May 2023 |
Main ID: |
RBR-42c6gz |
Date of registration:
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05/11/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Characterization of trigger points in the rectus abdominis muscle in women with chronic pelvic pain using electromyography.
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Scientific title:
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Characterization of local mechanisms (trigger points) of abdominal myofascial syndrome in women with chronic pelvic pain using surface and needle electromyography. |
Date of first enrolment:
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19/09/2010 |
Target sample size:
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Recruitment status: |
Data analysis completed |
URL:
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http://ensaiosclinicos.gov.br/rg/RBR-42c6gz |
Study type:
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Observational |
Study design:
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Analytical observational cohort study
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Suelen
Soares |
Address:
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Av. Bandeirantes, 3900
14.048-90
Ribeirão Preto
Brazil |
Telephone:
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+55(16)3602 2231 |
Email:
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pgdgo@fmrp.usp.br |
Affiliation:
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Departamento de Ginecologia e Obstetrícia - Comissão de Pesquisa |
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Name:
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Suelen
Soares |
Address:
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Av. Bandeirantes, 3900
14.048-90
Ribeirão Preto
Brazil |
Telephone:
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+55(16)3602 2231 |
Email:
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pgdgo@fmrp.usp.br |
Affiliation:
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Departamento de Ginecologia e Obstetrícia - Comissão de Pesquisa |
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Key inclusion & exclusion criteria
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Inclusion criteria: Women with chronic pelvic pain; age over 18 years; presence of all clinical diagnostic criteria for abdominal myofascial pain syndrome.
Exclusion criteria: Women with typical clinical symptoms of endometriosis or painful bladder syndrome or irritable bowel syndrome or other disease that justify or contribute to chronic pelvic pain; endometrioma or hernia evidenced by ultrasound of abdominal wall; obesity (BMI > 30 kg/m²); use of anticoagulant; coagulation disturbance.
Age minimum:
18Y
Age maximum:
60Y
Gender:
F
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Health Condition(s) or Problem(s) studied
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C23.888.646.587
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chronic pelvic pain, myofascial pain syndrome
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C05.651.550
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Intervention(s)
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Other
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The women included were initially interviewed to obtain clinical history and physical examination in order to confirm trigger point. The intensity of pain was evaluated by visual analog scale for pain and the pain threshold was measured in the forearm by algometry. These assessments were made in the first interview and after 3 months. All patients also underwent needle electromyography in trigger point and in a point contralateral painless by an independent observer, just once, right after the initial interview.
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E01.370.405.255
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Primary Outcome(s)
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Expected: We evaluated the pain intensity before and after the reference treatment by visual analogue pain scale; Found: 93.8% of women in the group of electromyographic changes had significant reduction in pain intensity; however, only 38.5% of women with normal EMG pattern showed significant improvement.
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Expected: Presence of abnormalities suggestive of denervation process and / or local reinnervation, evaluated by needle electromyography at trigger points; Found: 16 women had electromyographic changes and 13 had normal electromyographic patterns.
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Secondary Outcome(s)
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Expected: We evaluated the pain threshold at the trigger point before and after treatment by algometry (the minimum pressure required to cause the sensation of pain in trigger point); Found: there was no significant difference in pain thresholds, regardless of electromyographic patterns.
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Source(s) of Monetary Support
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Fundação de Amparo à Pesquisa do Estado de São Paulo
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Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (FAEPA)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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