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Transcutaneous electrical nerve stimulation for primary dysmenorrhoea in women: a randomized controlled trial with economic evaluation

Grant number: 19/14672-7
Support type:Scholarships in Brazil - Doctorate (Direct)
Effective date (Start): January 01, 2020
Effective date (End): March 31, 2023
Field of knowledge:Health Sciences - Physiotherapy and Occupational Therapy
Principal Investigator:Patricia Driusso
Grantee:Jéssica Cordeiro Rodrigues
Home Institution: Centro de Ciências Biológicas e da Saúde (CCBS). Universidade Federal de São Carlos (UFSCAR). São Carlos , SP, Brazil

Abstract

Primary Dysmenorrhea (PD) is a common gynecological disorder characterized by colic in the abdominal region in the absence of pelvic disease. Evidence on the use of Transcutaneous Electrical Nerve Stimulation (TENS) as a non-pharmacological method for improving pain intensity is insufficient in this clinical condition and there are no records on the evaluation of its cost effectiveness and cost utility. Objectives: To evaluate the effect of TENS on pain intensity in women affected by PD and to estimate the cost-effectiveness and cost-utility of TENS for women with PD. Methods: This is a randomized clinical trial with economic evaluation. Participants will be women over 18 years of age, without kids, with a regular menstrual cycle and a diagnosis of PD, with a report of pain equal to or greater than four points on the Numerical Rating Scale (NRS). The study will be submitted to the Ethics and Research Committee of the Federal University of São Carlos and will be registered at the Clinical Trial. After receiving the information about the project and signing the Informed Consent Term, participants will be evaluated with socio-demographic and clinical data and application of the following instruments: Generic Questionnaire for Quality of Life Assessment (SF-36) and 6-Dimensional Quality of Life Assessment Questionnaire (SF-6D). Participants will be randomized into three groups: Control group (TENS placebo), Intervention group (TENS) and Minimum intervention group (primer). Participants in the control group (TENS placebo) and in the intervention group (TENS) will be submitted to treatment with placebo TENS and active TENS, respectively. The application of TENS will be performed two days prior to three days after the first day of menstruation for three consecutive menstrual cycles, and participants will also be followed up for three more consecutive cycles. The data will be analyzed by the SPSS 22.0 program. Mixed linear models will be adopted, considering pain and cost as a dependent variable and the group and moment of evaluation as independent variables. The level of significance will be 5%. (AU)