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Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea

NCT ID: NCT03269591

Last Updated: 2017-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2016-10-29

Brief Summary

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

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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.

Conditions

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Electromagnetic Field Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
(Participant, Outcomes Assessor)

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Pulsed electromagnetic field

Intervention Type DEVICE

EASY Qs portable (by ASA, Italy)

diclofenac tablets

Intervention Type DRUG

drugs

Visual analogue scale

Intervention Type DIAGNOSTIC_TEST

a graphic rating scale

Progesterone blood level

Intervention Type DIAGNOSTIC_TEST

blood test

Menstrual symptom questionnaire

Intervention Type DIAGNOSTIC_TEST

questionnaire

diclofenac tablets

(50 mg) few hours at the onset of menstruation for 3 months

Group Type EXPERIMENTAL

Pulsed electromagnetic field

Intervention Type DEVICE

EASY Qs portable (by ASA, Italy)

diclofenac tablets

Intervention Type DRUG

drugs

Visual analogue scale

Intervention Type DIAGNOSTIC_TEST

a graphic rating scale

Progesterone blood level

Intervention Type DIAGNOSTIC_TEST

blood test

Menstrual symptom questionnaire

Intervention Type DIAGNOSTIC_TEST

questionnaire

Visual analogue scale

was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month)

Group Type OTHER

Pulsed electromagnetic field

Intervention Type DEVICE

EASY Qs portable (by ASA, Italy)

diclofenac tablets

Intervention Type DRUG

drugs

Visual analogue scale

Intervention Type DIAGNOSTIC_TEST

a graphic rating scale

Progesterone blood level

Intervention Type DIAGNOSTIC_TEST

blood test

Menstrual symptom questionnaire

Intervention Type DIAGNOSTIC_TEST

questionnaire

Progesterone blood level

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

Group Type OTHER

Pulsed electromagnetic field

Intervention Type DEVICE

EASY Qs portable (by ASA, Italy)

diclofenac tablets

Intervention Type DRUG

drugs

Visual analogue scale

Intervention Type DIAGNOSTIC_TEST

a graphic rating scale

Progesterone blood level

Intervention Type DIAGNOSTIC_TEST

blood test

Menstrual symptom questionnaire

Intervention Type DIAGNOSTIC_TEST

questionnaire

Menstrual symptom questionnaire

to assess symptoms of dysmenorrhea.

Group Type OTHER

Pulsed electromagnetic field

Intervention Type DEVICE

EASY Qs portable (by ASA, Italy)

diclofenac tablets

Intervention Type DRUG

drugs

Visual analogue scale

Intervention Type DIAGNOSTIC_TEST

a graphic rating scale

Progesterone blood level

Intervention Type DIAGNOSTIC_TEST

blood test

Menstrual symptom questionnaire

Intervention Type DIAGNOSTIC_TEST

questionnaire

Interventions

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Pulsed electromagnetic field

EASY Qs portable (by ASA, Italy)

Intervention Type DEVICE

diclofenac tablets

drugs

Intervention Type DRUG

Visual analogue scale

a graphic rating scale

Intervention Type DIAGNOSTIC_TEST

Progesterone blood level

blood test

Intervention Type DIAGNOSTIC_TEST

Menstrual symptom questionnaire

questionnaire

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

17 Years

Maximum Eligible Age

24 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Ebrahim El Refaye

Clinical lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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dr ghada

Identifier Type: -

Identifier Source: org_study_id

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