Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea: Arandomized Controlled Trial in the Egyptian Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Visual analogue scale
研究概览
简要总结
Electromagnetic field versus diclofenac drugs on primary dysmenorrhea: Arandomized controlled trial in the Egyptian women
详细描述
Background: Primary dysmenorrhea is one of the most common complaints of women and is also the most common gynecological problem worldwide. These cramps are recurrent and 90% adolescent girls and about 50% women suffer from it. Purpose of the study: to determine which is more effective in alleviating primary dysmenorrhea; pulsed electromagnetic field or diclofenac drugs. Methodology: The study was a randomized, double-blinded trial, fifty adult females participated in this study, were divided randomly into two groups equal in numbers: group (A) received pulsed electromagnetic field applied on pelvic region, 3 times per week for 3 months, 20 minutes per day and group (B) received diclofenac tablets, 50 mg only with onset of menstrual pain. All participants in both groups (A and B) were assessed pre- and post-treatment through measuring progesterone level in the blood, assessment of pain using visual analogue scale and physical as well as psychological symptoms by using menstrual symptom questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
(Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •regular menstrual cycle 21-35 days lasting 3-7 days
排除标准
- •Irregulars or infrequent menstrual cycles, Pacemaker, Myasthenia gravis, hyperthyroidism, active tuberculosis and psychosis
研究组 & 干预措施
Pulsed electromagnetic field
magnetic therapy device which generate frequency from 5-100 Hz and intensity from 1 to 60 Gauss. Group (A) received 20 min 3 times per week for three month with strength 60 gauss and frequency 50 Hz
干预措施: Pulsed electromagnetic field (Device)
Pulsed electromagnetic field
magnetic therapy device which generate frequency from 5-100 Hz and intensity from 1 to 60 Gauss. Group (A) received 20 min 3 times per week for three month with strength 60 gauss and frequency 50 Hz
干预措施: diclofenac tablets (Drug)
Pulsed electromagnetic field
magnetic therapy device which generate frequency from 5-100 Hz and intensity from 1 to 60 Gauss. Group (A) received 20 min 3 times per week for three month with strength 60 gauss and frequency 50 Hz
干预措施: Visual analogue scale (Diagnostic Test)
Pulsed electromagnetic field
magnetic therapy device which generate frequency from 5-100 Hz and intensity from 1 to 60 Gauss. Group (A) received 20 min 3 times per week for three month with strength 60 gauss and frequency 50 Hz
干预措施: Progesterone blood level (Diagnostic Test)
Pulsed electromagnetic field
magnetic therapy device which generate frequency from 5-100 Hz and intensity from 1 to 60 Gauss. Group (A) received 20 min 3 times per week for three month with strength 60 gauss and frequency 50 Hz
干预措施: Menstrual symptom questionnaire (Diagnostic Test)
diclofenac tablets
(50 mg) few hours at the onset of menstruation for 3 months
干预措施: Pulsed electromagnetic field (Device)
diclofenac tablets
(50 mg) few hours at the onset of menstruation for 3 months
干预措施: diclofenac tablets (Drug)
diclofenac tablets
(50 mg) few hours at the onset of menstruation for 3 months
干预措施: Visual analogue scale (Diagnostic Test)
diclofenac tablets
(50 mg) few hours at the onset of menstruation for 3 months
干预措施: Progesterone blood level (Diagnostic Test)
diclofenac tablets
(50 mg) few hours at the onset of menstruation for 3 months
干预措施: Menstrual symptom questionnaire (Diagnostic Test)
Visual analogue scale
was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month)
干预措施: Pulsed electromagnetic field (Device)
Visual analogue scale
was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month)
干预措施: diclofenac tablets (Drug)
Visual analogue scale
was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month)
干预措施: Visual analogue scale (Diagnostic Test)
Visual analogue scale
was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month)
干预措施: Progesterone blood level (Diagnostic Test)
Visual analogue scale
was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month)
干预措施: Menstrual symptom questionnaire (Diagnostic Test)
Progesterone blood level
Sample of blood was taken to detect the level of progesterone.
干预措施: Pulsed electromagnetic field (Device)
Progesterone blood level
Sample of blood was taken to detect the level of progesterone.
干预措施: diclofenac tablets (Drug)
Progesterone blood level
Sample of blood was taken to detect the level of progesterone.
干预措施: Visual analogue scale (Diagnostic Test)
Progesterone blood level
Sample of blood was taken to detect the level of progesterone.
干预措施: Progesterone blood level (Diagnostic Test)
Progesterone blood level
Sample of blood was taken to detect the level of progesterone.
干预措施: Menstrual symptom questionnaire (Diagnostic Test)
Menstrual symptom questionnaire
to assess symptoms of dysmenorrhea.
干预措施: Pulsed electromagnetic field (Device)
Menstrual symptom questionnaire
to assess symptoms of dysmenorrhea.
干预措施: diclofenac tablets (Drug)
Menstrual symptom questionnaire
to assess symptoms of dysmenorrhea.
干预措施: Visual analogue scale (Diagnostic Test)
Menstrual symptom questionnaire
to assess symptoms of dysmenorrhea.
干预措施: Progesterone blood level (Diagnostic Test)
Menstrual symptom questionnaire
to assess symptoms of dysmenorrhea.
干预措施: Menstrual symptom questionnaire (Diagnostic Test)
结局指标
主要结局
Visual analogue scale
时间窗: three months
was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month); in both groups (A and B) by (16), it is a graphic rating scale with numerical values placed equidistantly along the line. The descriptors and numbers help the subject to place her estimate on line in which (0) mean no pain, (1) equal mild pain, (2) equal moderate pain, (3) mean severe pain and (4) mean unbearable pain.
次要结局
- Progesterone blood level(three months)
- Menstrual symptom questionnaire(three months)
研究者
Ghada Ebrahim El Refaye
Clinical lecturer
Cairo University