Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea

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

Detailed Description
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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.

Official Title
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Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea: Arandomized Controlled Trial in the Egyptian Women

Conditions
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Electromagnetic Field, Dysmenorrhea

Intervention / Treatment
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* Device: Pulsed electromagnetic field
* Drug: diclofenac tablets
* Diagnostic Test: Visual analogue scale
* Diagnostic Test: Progesterone blood level
* Diagnostic Test: Menstrual symptom questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -regular menstrual cycle 21-35 days lasting 3-7 days Exclusion Criteria: Irregulars or infrequent menstrual cycles, Pacemaker, Myasthenia gravis, hyperthyroidism, active tuberculosis and psychosis

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulsed electromagnetic field<br>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 | Device: Pulsed electromagnetic field<br>* EASY Qs portable (by ASA, Italy)<br>Drug: diclofenac tablets<br>* drugs<br>Diagnostic Test: Visual analogue scale<br>* a graphic rating scale<br>Diagnostic Test: Progesterone blood level<br>* blood test<br>Diagnostic Test: Menstrual symptom questionnaire<br>* questionnaire<br>|
| Experimental: diclofenac tablets<br>(50 mg) few hours at the onset of menstruation for 3 months | Device: Pulsed electromagnetic field<br>* EASY Qs portable (by ASA, Italy)<br>Drug: diclofenac tablets<br>* drugs<br>Diagnostic Test: Visual analogue scale<br>* a graphic rating scale<br>Diagnostic Test: Progesterone blood level<br>* blood test<br>Diagnostic Test: Menstrual symptom questionnaire<br>* questionnaire<br>|
| Other: Visual analogue scale<br>was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month) | Device: Pulsed electromagnetic field<br>* EASY Qs portable (by ASA, Italy)<br>Drug: diclofenac tablets<br>* drugs<br>Diagnostic Test: Visual analogue scale<br>* a graphic rating scale<br>Diagnostic Test: Progesterone blood level<br>* blood test<br>Diagnostic Test: Menstrual symptom questionnaire<br>* questionnaire<br>|
| Other: Progesterone blood level<br>Sample of blood was taken to detect the level of progesterone. | Device: Pulsed electromagnetic field<br>* EASY Qs portable (by ASA, Italy)<br>Drug: diclofenac tablets<br>* drugs<br>Diagnostic Test: Visual analogue scale<br>* a graphic rating scale<br>Diagnostic Test: Progesterone blood level<br>* blood test<br>Diagnostic Test: Menstrual symptom questionnaire<br>* questionnaire<br>|
| Other: Menstrual symptom questionnaire<br>to assess symptoms of dysmenorrhea. | Device: Pulsed electromagnetic field<br>* EASY Qs portable (by ASA, Italy)<br>Drug: diclofenac tablets<br>* drugs<br>Diagnostic Test: Visual analogue scale<br>* a graphic rating scale<br>Diagnostic Test: Progesterone blood level<br>* blood test<br>Diagnostic Test: Menstrual symptom questionnaire<br>* questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | 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. | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progesterone blood level | Sample of blood was taken to detect the level of progesterone. | three months | 
| Menstrual symptom questionnaire | to assess symptoms of dysmenorrhea | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysmenorrhea, Pulsed electromagnetic field, Diclofenac