Efficacy of Indian make Transcutaneous Electric Nerve Stimulation Device Matri in women with Primary Dysmenorrhoea- A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1. To evaluate the effectiveness of the new Indian make TENS device (Matri)
研究概览
简要总结
Primary dysmenorrhea is a common gynaecological problem consisting of painful
cramps accompanying menstruation, without any evident pathology to account to it.
The uterus is induced to contract frequently and disrhythmically, with increased basal
tone and increased active pressure. The disease occurs in up to 50% of menstruating
females and causes significant disruption in quality of life in 20%, resulting in non-
attendance at work or school (1-4). The available treatment for this are nonsteroidal
anti-inflammatory drugs and oral contraceptive pills OCPs which are often associated
with adverse events (AEs). So many patients avoid taking them, and seek for other
non-pharmaceutical alternatives.
Transcutaneous electrical nerve stimulation (TENS), working on Gate control theory,
is an established method for pain relief in various chronic conditions such as arthritis,
back pain etc. This method offers a potential non-pharmaceutical alternative therapy
for dysmenorrhea. It has been used in few research projects but is still not widely used
for this indication (5-8).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 14.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women suffering from primary dysmenorrhoea with regular cycles
- •Working ability, Location, Intensity, Days of dysmenorrhea score (WaLIDD score) more than or equal 5
排除标准
- •Women taking Oral Contraceptive Pills OCPs
- •Patients with dysmenorrhea secondary to the pathologies like endometriosis, uterine myoma, uterine malformations, other similar uterine diseases, pelvic inflammatory disease, congenital Mullerian anomalies, ovarian cysts, or inflammatory bowel disease.
结局指标
主要结局
1. To evaluate the effectiveness of the new Indian make TENS device (Matri)
时间窗: 1. To evaluate the effectiveness of the new Indian make TENS device (Matri) | for managing Primary Dysmenorrhoea using subjective Visual Analog Scale | pain score (VAS score) at base line , 1 month and 2nd month from base line
for managing Primary Dysmenorrhoea using subjective Visual Analog Scale
时间窗: 1. To evaluate the effectiveness of the new Indian make TENS device (Matri) | for managing Primary Dysmenorrhoea using subjective Visual Analog Scale | pain score (VAS score) at base line , 1 month and 2nd month from base line
pain score (VAS score)
时间窗: 1. To evaluate the effectiveness of the new Indian make TENS device (Matri) | for managing Primary Dysmenorrhoea using subjective Visual Analog Scale | pain score (VAS score) at base line , 1 month and 2nd month from base line
次要结局
- 1. To assess the perceived adverse reactions of the new Indian make(Transcutaneous Electric Nerve Stimulation TENS Device (Matri))
研究者
Dr Ritu Sharma
Government Institute of Medical Sciences (GIMS)