Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea (magnetic)

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

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

Study Overview

• Status: Completed
• Conditions: Dysmenorrhea; Electromagnetic Field
• Intervention / Treatment: Device: Pulsed electromagnetic field; Drug: diclofenac tablets; Diagnostic test: Visual analogue scale; Diagnostic test: Progesterone blood level; Diagnostic test: Menstrual symptom questionnaire

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): September 30, 2016
• Study Completion (Actual): October 29, 2016

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Dysmenorrhea; Pulsed electromagnetic field; Diclofenac
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Diclofenac; Progesterone
• Other Study ID Numbers: dr ghada

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Electromagnetic field versus diclofenac drugs on primary dysmenorrhea: Arandomized controlled trial in the Egyptian women
• IPD Sharing Time Frame: three months
• IPD Sharing Access Criteria: the protocol of study, for 3 months
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No