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CompletedNCT03269591magneticUpdated Sep 1, 2017

Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea

An interventional study of Pulsed electromagnetic field and diclofenac tablets in Electromagnetic Field and Dysmenorrhea, sponsored by Cairo University. Completed. Open to female participants aged 17 Years to 24 Years. Per ClinicalTrials.gov, last updated 2017-09-01.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
17 Years to 24 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Electromagnetic Field
  • Dysmenorrhea

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Keywords

  • Dysmenorrhea
  • Pulsed electromagnetic field
  • Diclofenac
03

Who can participate

Ages eligible
17 Years to 24 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Irregulars or infrequent menstrual cycles, Pacemaker, Myasthenia gravis, hyperthyroidism, active tuberculosis and psychosis
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • 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

    Device: Pulsed electromagnetic field · Drug: diclofenac tablets · Diagnostic Test: Visual analogue scale · Diagnostic Test: Progesterone blood level · Diagnostic Test: Menstrual symptom questionnaire

  • Experimental
    diclofenac tablets

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

    Device: Pulsed electromagnetic field · Drug: diclofenac tablets · Diagnostic Test: Visual analogue scale · Diagnostic Test: Progesterone blood level · Diagnostic Test: Menstrual symptom questionnaire

  • Other
    Visual analogue scale

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

    Device: Pulsed electromagnetic field · Drug: diclofenac tablets · Diagnostic Test: Visual analogue scale · Diagnostic Test: Progesterone blood level · Diagnostic Test: Menstrual symptom questionnaire

  • Other
    Progesterone blood level

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

    Device: Pulsed electromagnetic field · Drug: diclofenac tablets · Diagnostic Test: Visual analogue scale · Diagnostic Test: Progesterone blood level · Diagnostic Test: Menstrual symptom questionnaire

  • Other
    Menstrual symptom questionnaire

    to assess symptoms of dysmenorrhea.

    Device: Pulsed electromagnetic field · Drug: diclofenac tablets · Diagnostic Test: Visual analogue scale · Diagnostic Test: Progesterone blood level · Diagnostic Test: Menstrual symptom questionnaire

Interventions

  • DevicePulsed electromagnetic field

    EASY Qs portable (by ASA, Italy)

  • Drugdiclofenac tablets

    drugs

  • Diagnostic testVisual analogue scale

    a graphic rating scale

  • Diagnostic testProgesterone blood level

    blood test

  • Diagnostic testMenstrual symptom questionnaire

    questionnaire

05

What researchers measure

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.

    Time frame: three months

Secondary outcomes

  1. Progesterone blood level

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

    Time frame: three months

  2. Menstrual symptom questionnaire

    to assess symptoms of dysmenorrhea

    Time frame: three months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Yes — Electromagnetic field versus diclofenac drugs on primary dysmenorrhea: Arandomized controlled trial in the Egyptian women

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03269591
Lead sponsor
Cairo University
Responsible party
Ghada Ebrahim El Refaye (Clinical lecturer, Cairo University) — Principal investigator
First posted
Sep 1, 2017
Start date
Feb 1, 2016
Primary completion
Sep 30, 2016
Completion
Oct 29, 2016
Last update
Sep 1, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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