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EFFECTS OF CONNECTIVE TISSUE MANIPULATION IN THE TREATMENT OF WOMEN WITH PRIMARY DYSMENORRHEA: A CLINICAL TRIAL, DOUBLE-BLIND, PLACEBO-CONTROLLED.

Grant number: 23/08474-3
Support Opportunities:Scholarships in Brazil - Scientific Initiation
Start date: November 01, 2023
End date: December 31, 2024
Field of knowledge:Health Sciences - Physiotherapy and Occupational Therapy
Principal Investigator:Helen Cristina Nogueira Carrer
Grantee:Giovanna Ramos Mansão
Host Institution: Centro de Ciências Biológicas e da Saúde (CCBS). Universidade Federal de São Carlos (UFSCAR). São Carlos , SP, Brazil
Associated scholarship(s):24/01937-0 - THE IMPORTANCE OF HEALTH LITERACY FOR THE DYSMENORRHEA WOMEN SELF CARE: A PARTICIPATORY DESIGN OF INFOGRAPHICS FOR THE APPROPRIATE MANAGEMENT OF THE MENSTRUAL PAIN, BE.EP.IC

Abstract

Primary dysmenorrhea is a common gynecological condition characterized by the presence of acute pain and at intervals, above the suprapublic region during menstruation and without the presence of pelvic abnormalities. The connective tissue manipulation (CTM) is a manual therapy technique that can have positive effects in the treatment of dysmenorrhea, however there is still a variability in responses to treatment. Therefore, the aim of this study is to investigate the effects of CTM in the treatment of women with primary dysmenorrhea through the analysis of clinical outcomes, such as pain intensity, occurrence of menstrual symptom and medication use, when compared to the sham maneuver. This is a randomized, controlled, double-blind superiority clinical trial with two parallel groups (experimental and placebo) and primary outcome after the intervention period. Will be included 34 women, nullipara, >18 years old, with regular menstrual cycle, presence of menstrual pain within 72 hours of the onset of menstruation, without gynecological disorder diagnosed, pain intensity greater than or equal 4 points on the Numerical Rating Scale (NRS) on the last menstrual cycle and that have menstruated in the last 30 days. The blinded assessor will be responsible for collecting the outcomes in the first menstrual period after the beginning of study participation and in the period of following intervention. The participants will be randomized into two groups: active CTM and placebo CTM. The experimental technique will consist of deep gliding strokes capable of generating traction on the skin on the sacroiliac, lumbar, lower thoracic and anterior pelvic regions. The sham maneuver will consist of the same moves and in the same regions, but without the necessary pressure to generate traction on the skin. In both groups, the treatment session will last 10 minutes and will be performed 3 times per week, from the beginning of the ovulatory period until the beginning of the next menstruation. The data collected will be present descriptively, in an Excel spreadsheet, and analyzed using the SPSS program. The normality of the data will be tested by the Shapiro-Wilk test and the comparison between groups will be performed with a statistical test (ANOVA or Wilcoxon). The pain intensity and the number of menstrual symptoms and consumed medications for dysmenorrhea will be analyzed using two-way ANOVA, with 2 groups (experimental and placebo) X 2 times (T1 and T2). The level of significance adopted will be set at 5%.

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