Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea

Overview

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

Full Title of Study: “Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea: Arandomized Controlled Trial in the Egyptian Women”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 30, 2016

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.

Interventions

  • 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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Visual analogue scale
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

females

Minimum Age: 17 Years

Maximum Age: 24 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ghada Ebrahim El Refaye, Clinical lecturer – Cairo University

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