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Completed

NCT Number: NCT03269591

Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea

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

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Key information

Conditions

Electromagnetic Field Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

17 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed electromagnetic field

Device

EASY Qs portable (by ASA, Italy)

diclofenac tablets

Drug

drugs

Visual Analogue Scale

Diagnostic Test

a graphic rating scale

Progesterone blood level

Diagnostic Test

blood test

Menstrual symptom questionnaire

Diagnostic Test

questionnaire

Primary outcomes

  1. 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 outcomes

  1. Progesterone blood level

    Time frame: three months

    Sample of blood was taken to detect the level of progesterone.

  2. Menstrual symptom questionnaire

    Time frame: three months

    to assess symptoms of dysmenorrhea

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: magnetic

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 1, 2017
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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