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临床试验/CTRI/2025/07/090054
CTRI/2025/07/090054尚未招募1 期

Effects of micro current therapy and transcutaneous electrical nerve stimulation on menstrual symptoms, quality of life and cortisol levels in primary dysmenorrhea

Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences1 个研究点 分布在 1 个国家目标入组 274 人开始时间: 2025年7月21日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
274
试验地点
1
主要终点
Cortisol

研究概览

简要总结

This randomized controlled trial aims to assess the effectiveness of Microcurrent Therapy and Transcutaneous Electrical Nerve Stimulation  in managing Primary Dysmenorrhea in young women. Primary dysmenorrhea refers to menstrual pain without underlying pelvic pathology and is a common gynecological complaint that impacts the quality of life, daily functioning, and psychological well-being.

Participants will be randomly allocated into two groups: Group A will receive Microcurrent therapy and group B will receive trancutaneuos electrical nerve stimulation therapy

Both interventions will be administered during the first three days of menstruation for three consecutive menstrual cycles. Each session will follow standardized parameters and treatment duration under the supervision of a trained physiotherapist. These therapies are safe, non-invasive, drug-free, and simple to administer, with minimal to no side effects, making them suitable for routine clinical use.

The study population will be recruited based on the selection criteria.

The following outcome measures will be assessed- cortisol, menstrual symptoms questionnaire, quality of life. Basic menstrual and Gynecological physiotherapy assessment will be carried out before intervention. Outcome assessments will be conducted at baseline and after completion of three treatment cycles to evaluate the treatment effects.

All participants will receive a participant information sheet that clearly outlines the study’s purpose, procedures, potential benefits, and risks. Written informed consent will be obtained prior to participation, ensuring full understanding, confidentiality and voluntary involvement. Participants may withdraw from the study at any point without penalty.

This trial aims to explore effective, non-pharmacological strategies for the management of primary dysmenorrhea and promote physiotherapy-based pain relief methods that can enhance the overall health and well-being of affected women.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 25.00 Year(s)(—)
性别
Female

入选标准

  • Self- reported dysmenorrhea in the age group of 18-25 years Had regular menstrual cycles (28-32 days) Menstrual pain scoring at least 4 on NPRS for at least two consecutive months.
  • Both single and married women Nullipara.

排除标准

  • Women on oral contraceptives and hormonal therapy.
  • Continued pain medication (analgesics or NSAIDs) for pain History of hospitalization due to any pelvic diseases or gynecological diseases Female with history of any specific diseases and compulsory use of specific drugs Contraindication to the use of Microcurrent and TENS Recent abdominal or skin lesions.

结局指标

主要结局

Cortisol

时间窗: Baseline and Post intervention

Menstrual symptom questionnaire

时间窗: Baseline and Post intervention

36-item short-form quality of life

时间窗: Baseline and Post intervention

次要结局

未报告次要终点

研究者

发起方
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Suriya N

Saveetha Institute of Medical and Technical Sciences

研究点 (1)

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