Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea

Dysmenorrhea Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03269591
• Other study ID #: dr ghada
• Status: Completed
• Phase: N/A
• First received: August 30, 2017
• Last updated: August 31, 2017
• Start date: February 1, 2016
• Est. completion date: October 29, 2016

Study information

• Verified date: August 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 29, 2016
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Electromagnetic Field

Intervention

Device:
• Pulsed electromagnetic field
EASY Qs portable (by ASA, Italy)

Drug:
• diclofenac tablets
drugs

Diagnostic Test:
• Visual analogue scale
a graphic rating scale
• Progesterone blood level
blood test
• Menstrual symptom questionnaire
questionnaire

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progesterone blood level	Sample of blood was taken to detect the level of progesterone.	three months
Secondary	Menstrual symptom questionnaire	to assess symptoms of dysmenorrhea	three months