Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea

Not Applicable

Completed

• Conditions: Dysmenorrhea; Electromagnetic Field
• Interventions: Device: Pulsed electromagnetic field; Drug: diclofenac tablets; Diagnostic Test: Visual analogue scale; Diagnostic Test: Progesterone blood level; Diagnostic Test: Menstrual symptom questionnaire

• Registration Number: NCT03269591
• Lead Sponsor: Cairo University

Brief Summary

Electromagnetic field versus diclofenac drugs on primary dysmenorrhea: Arandomized controlled trial in the Egyptian women

Detailed Description

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.

Study Timeline

• Study Start: 2016-02-01
• Primary Completion: 2016-09-30
• Study Completion: 2016-10-29
• Status Verified: 2017-08
• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-08-31
• Last Update Submitted: 2017-08-31
• Study First Posted: 2017-09-01
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

-regular menstrual cycle 21-35 days lasting 3-7 days

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Exclusion Criteria

• Irregulars or infrequent menstrual cycles, Pacemaker, Myasthenia gravis, hyperthyroidism, active tuberculosis and psychosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Menstrual symptom questionnaire	diclofenac tablets	to assess symptoms of dysmenorrhea.
Pulsed electromagnetic field	diclofenac tablets	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
Pulsed electromagnetic field	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
diclofenac tablets	Pulsed electromagnetic field	(50 mg) few hours at the onset of menstruation for 3 months
diclofenac tablets	diclofenac tablets	(50 mg) few hours at the onset of menstruation for 3 months
Visual analogue scale	Pulsed electromagnetic field	was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month)
Pulsed electromagnetic field	Visual analogue scale	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
diclofenac tablets	Visual analogue scale	(50 mg) few hours at the onset of menstruation for 3 months
Visual analogue scale	diclofenac tablets	was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month)
Progesterone blood level	diclofenac tablets	Sample of blood was taken to detect the level of progesterone.
Progesterone blood level	Menstrual symptom questionnaire	Sample of blood was taken to detect the level of progesterone.
diclofenac tablets	Menstrual symptom questionnaire	(50 mg) few hours at the onset of menstruation for 3 months
Progesterone blood level	Pulsed electromagnetic field	Sample of blood was taken to detect the level of progesterone.
Progesterone blood level	Visual analogue scale	Sample of blood was taken to detect the level of progesterone.
Pulsed electromagnetic field	Progesterone blood level	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
Visual analogue scale	Visual analogue scale	was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month)
Visual analogue scale	Progesterone blood level	was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month)
Menstrual symptom questionnaire	Pulsed electromagnetic field	to assess symptoms of dysmenorrhea.
Menstrual symptom questionnaire	Progesterone blood level	to assess symptoms of dysmenorrhea.
Menstrual symptom questionnaire	Menstrual symptom questionnaire	to assess symptoms of dysmenorrhea.
Pulsed electromagnetic field	Menstrual symptom questionnaire	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
diclofenac tablets	Progesterone blood level	(50 mg) few hours at the onset of menstruation for 3 months
Visual analogue scale	Menstrual symptom questionnaire	was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month)
Progesterone blood level	Progesterone blood level	Sample of blood was taken to detect the level of progesterone.
Menstrual symptom questionnaire	Visual analogue scale	to assess symptoms of dysmenorrhea.

Primary Outcome Measures

Name	Time	Method
Visual analogue scale	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.

Secondary Outcome Measures

Name	Time	Method
Progesterone blood level	three months	Sample of blood was taken to detect the level of progesterone.
Menstrual symptom questionnaire	three months	to assess symptoms of dysmenorrhea