Back to resultsElectromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea (magnetic)
Primary Purpose
Electromagnetic Field, Dysmenorrhea
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulsed electromagnetic field
diclofenac tablets
Visual analogue scale
Progesterone blood level
Menstrual symptom questionnaire
Sponsored by
About this trial
This is an interventional treatment trial for Electromagnetic Field focused on measuring Dysmenorrhea, Pulsed electromagnetic field, Diclofenac
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Experimental
Other
Other
Other
Arm Label
Pulsed electromagnetic field
diclofenac tablets
Visual analogue scale
Progesterone blood level
Menstrual symptom questionnaire
Arm Description
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
(50 mg) few hours at the onset of menstruation for 3 months
was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month)
Sample of blood was taken to detect the level of progesterone.
to assess symptoms of dysmenorrhea.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Progesterone blood level
Sample of blood was taken to detect the level of progesterone.
Menstrual symptom questionnaire
to assess symptoms of dysmenorrhea
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03269591
Brief Title
Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea
Acronym
magnetic
Official Title
Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea: Arandomized Controlled Trial in the Egyptian Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
October 29, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Electromagnetic field versus diclofenac drugs on primary dysmenorrhea: Arandomized controlled trial in the Egyptian women
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electromagnetic Field, Dysmenorrhea
Keywords
Dysmenorrhea, Pulsed electromagnetic field, Diclofenac
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
(Participant, Outcomes Assessor)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pulsed electromagnetic field
Arm Type
Active Comparator
Arm Description
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
Arm Title
diclofenac tablets
Arm Type
Experimental
Arm Description
(50 mg) few hours at the onset of menstruation for 3 months
Arm Title
Visual analogue scale
Arm Type
Other
Arm Description
was used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month)
Arm Title
Progesterone blood level
Arm Type
Other
Arm Description
Sample of blood was taken to detect the level of progesterone.
Arm Title
Menstrual symptom questionnaire
Arm Type
Other
Arm Description
to assess symptoms of dysmenorrhea.
Intervention Type
Device
Intervention Name(s)
Pulsed electromagnetic field
Intervention Description
EASY Qs portable (by ASA, Italy)
Intervention Type
Drug
Intervention Name(s)
diclofenac tablets
Intervention Description
drugs
Intervention Type
Diagnostic Test
Intervention Name(s)
Visual analogue scale
Intervention Description
a graphic rating scale
Intervention Type
Diagnostic Test
Intervention Name(s)
Progesterone blood level
Intervention Description
blood test
Intervention Type
Diagnostic Test
Intervention Name(s)
Menstrual symptom questionnaire
Intervention Description
questionnaire
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
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.
Time Frame
three months
Secondary Outcome Measure Information:
Title
Progesterone blood level
Description
Sample of blood was taken to detect the level of progesterone.
Time Frame
three months
Title
Menstrual symptom questionnaire
Description
to assess symptoms of dysmenorrhea
Time Frame
three months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
females
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea
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