NCT03269591

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

August 30, 2017

Last Update Submit

August 31, 2017

Conditions

Electromagnetic FieldDysmenorrhea

Keywords

DysmenorrheaPulsed electromagnetic fieldDiclofenac

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Progesterone blood level

    three months

  • Menstrual symptom questionnaire

    three months

Study Arms (5)

Pulsed electromagnetic field

ACTIVE COMPARATOR

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 fieldDrug: diclofenac tabletsDiagnostic Test: Visual analogue scaleDiagnostic Test: Progesterone blood levelDiagnostic Test: Menstrual symptom questionnaire

diclofenac tablets

EXPERIMENTAL

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

Device: Pulsed electromagnetic fieldDrug: diclofenac tabletsDiagnostic Test: Visual analogue scaleDiagnostic Test: Progesterone blood levelDiagnostic Test: Menstrual symptom questionnaire

Visual analogue scale

OTHER

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

Device: Pulsed electromagnetic fieldDrug: diclofenac tabletsDiagnostic Test: Visual analogue scaleDiagnostic Test: Progesterone blood levelDiagnostic Test: Menstrual symptom questionnaire

Progesterone blood level

OTHER

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

Device: Pulsed electromagnetic fieldDrug: diclofenac tabletsDiagnostic Test: Visual analogue scaleDiagnostic Test: Progesterone blood levelDiagnostic Test: Menstrual symptom questionnaire

Menstrual symptom questionnaire

OTHER

to assess symptoms of dysmenorrhea.

Device: Pulsed electromagnetic fieldDrug: diclofenac tabletsDiagnostic Test: Visual analogue scaleDiagnostic Test: Progesterone blood levelDiagnostic Test: Menstrual symptom questionnaire

Interventions

Pulsed electromagnetic fieldDEVICE

EASY Qs portable (by ASA, Italy)

Menstrual symptom questionnaireProgesterone blood levelPulsed electromagnetic fieldVisual analogue scalediclofenac tablets
diclofenac tabletsDRUG

drugs

Menstrual symptom questionnaireProgesterone blood levelPulsed electromagnetic fieldVisual analogue scalediclofenac tablets
Visual analogue scaleDIAGNOSTIC_TEST

a graphic rating scale

Menstrual symptom questionnaireProgesterone blood levelPulsed electromagnetic fieldVisual analogue scalediclofenac tablets
Progesterone blood levelDIAGNOSTIC_TEST

blood test

Menstrual symptom questionnaireProgesterone blood levelPulsed electromagnetic fieldVisual analogue scalediclofenac tablets
Menstrual symptom questionnaireDIAGNOSTIC_TEST

questionnaire

Menstrual symptom questionnaireProgesterone blood levelPulsed electromagnetic fieldVisual analogue scalediclofenac tablets

Eligibility Criteria

Age17 Years - 24 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • regular menstrual cycle 21-35 days lasting 3-7 days

You may not qualify if:

  • Irregulars or infrequent menstrual cycles, Pacemaker, Myasthenia gravis, hyperthyroidism, active tuberculosis and psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dysmenorrhea

Interventions

DiclofenacPain Measurement

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsNeurologic ExaminationPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
(Participant, Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical lecturer

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 1, 2017

Study Start

February 1, 2016

Primary Completion

September 30, 2016

Study Completion

October 29, 2016

Last Updated

September 1, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
three months
Access Criteria
the protocol of study, for 3 months