Electromagnetic FieldmagneticNCT03269591
Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea
A study testing Pulsed electromagnetic field, diclofenac tablets and Visual analogue scale in people with Electromagnetic Field and Dysmenorrhea, run by Cairo University.
Trial summary
Electromagnetic field versus diclofenac drugs on primary dysmenorrhea: Arandomized controlled trial in the Egyptian women Read more about this study
- Who is it for?
- Ages 17 to 24 years, women only
- Conditions the study is for
- Electromagnetic Field, Dysmenorrhea
- What is being tested?
- Pulsed electromagnetic field, diclofenac tablets and Visual analogue scale
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 29 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- -regular menstrual cycle 21-35 days lasting 3-7 days
Who cannot join
- Irregulars or infrequent menstrual cycles, Pacemaker, Myasthenia gravis, hyperthyroidism, active tuberculosis and psychosis
About this study
Official title: Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea: Arandomized Controlled Trial in the Egyptian Women
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.
- Conditions
- Electromagnetic Field, Dysmenorrhea
- Being tested
- Pulsed electromagnetic field, diclofenac tablets, Visual analogue scale, Progesterone blood level, Menstrual symptom questionnaire
- Keywords
- Dysmenorrhea, Pulsed electromagnetic field, Diclofenac
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electromagnetic fieldDevice
EASY Qs portable (by ASA, Italy)
diclofenac tabletsDrug
drugs
Visual analogue scaleDiagnostic test
a graphic rating scale
Progesterone blood levelDiagnostic test
blood test
Menstrual symptom questionnaireDiagnostic test
questionnaire
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Pulsed electromagnetic field; Drug: diclofenac tablets; Diagnostic Test: Visual analogue scale; Diagnostic Test: Progesterone blood level; Diagnostic Test: Menstrual symptom questionnaire |
| diclofenac tablets | Experimental | (50 mg) few hours at the onset of menstruation for 3 months Receives: Device: Pulsed electromagnetic field; Drug: diclofenac tablets; Diagnostic Test: Visual analogue scale; Diagnostic Test: Progesterone blood level; Diagnostic 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) Receives: Device: Pulsed electromagnetic field; Drug: diclofenac tablets; Diagnostic Test: Visual analogue scale; Diagnostic Test: Progesterone blood level; Diagnostic Test: Menstrual symptom questionnaire |
| Progesterone blood level | Other | Sample of blood was taken to detect the level of progesterone. Receives: Device: Pulsed electromagnetic field; Drug: diclofenac tablets; Diagnostic Test: Visual analogue scale; Diagnostic Test: Progesterone blood level; Diagnostic Test: Menstrual symptom questionnaire |
| Menstrual symptom questionnaire | Other | to assess symptoms of dysmenorrhea. Receives: Device: Pulsed electromagnetic field; Drug: diclofenac tablets; Diagnostic Test: Visual analogue scale; Diagnostic Test: Progesterone blood level; Diagnostic Test: Menstrual symptom questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three months
Secondary outcomes (2)
Progesterone blood level
Sample of blood was taken to detect the level of progesterone.
Measured: three months
Menstrual symptom questionnaire
to assess symptoms of dysmenorrhea
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Feb 2016
- Primary completion30 Sep 2016
- Study completion29 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electromagnetic FieldStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Ebrahim El Refaye, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269591
- Sponsor's protocol ID
- dr ghada
- Acronym
- magnetic
- Status last verified
- Aug 2017
- First submitted
- 30 Aug 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Electromagnetic field versus diclofenac drugs on primary dysmenorrhea: Arandomized controlled trial in the Egyptian women
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea: Arandomized Controlled Trial in the Egyptian Women
- ClinicalTrials.gov ID
- NCT03269591
- Acronym / sponsor ID
- magnetic / dr ghada
- Conditions
- Electromagnetic Field, Dysmenorrhea
- Keywords
- Dysmenorrhea, Pulsed electromagnetic field, Diclofenac
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 29 Oct 2016 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pulsed electromagnetic field | Active comparator | Device: Pulsed electromagnetic field, Drug: diclofenac tablets, Diagnostic Test: Visual analogue scale, Diagnostic Test: Progesterone blood level, Diagnostic Test: Menstrual symptom questionnairemagnetic 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 |
| diclofenac tablets | Experimental | Device: Pulsed electromagnetic field, Drug: diclofenac tablets, Diagnostic Test: Visual analogue scale, Diagnostic Test: Progesterone blood level, Diagnostic Test: Menstrual symptom questionnaire(50 mg) few hours at the onset of menstruation for 3 months |
| Visual analogue scale | Other | Device: Pulsed electromagnetic field, Drug: diclofenac tablets, Diagnostic Test: Visual analogue scale, Diagnostic Test: Progesterone blood level, Diagnostic Test: Menstrual symptom questionnairewas used to determine the pain intensity level. Pain assessed before and after treatment procedure (3 month) |
| Progesterone blood level | Other | Device: Pulsed electromagnetic field, Drug: diclofenac tablets, Diagnostic Test: Visual analogue scale, Diagnostic Test: Progesterone blood level, Diagnostic Test: Menstrual symptom questionnaireSample of blood was taken to detect the level of progesterone. |
| Menstrual symptom questionnaire | Other | Device: Pulsed electromagnetic field, Drug: diclofenac tablets, Diagnostic Test: Visual analogue scale, Diagnostic Test: Progesterone blood level, Diagnostic Test: Menstrual symptom questionnaireto assess symptoms of dysmenorrhea. |
Who may qualify
- Ages
- 17 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- -regular menstrual cycle 21-35 days lasting 3-7 days
Key exclusion criteria (1 listed)
- Irregulars or infrequent menstrual cycles, Pacemaker, Myasthenia gravis, hyperthyroidism, active tuberculosis and psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed electromagnetic fieldEASY Qs portable (by ASA, Italy) | Device | Menstrual symptom questionnaire, Progesterone blood level, Pulsed electromagnetic field, Visual analogue scale, diclofenac tablets |
| diclofenac tabletsdrugs | Drug | Menstrual symptom questionnaire, Progesterone blood level, Pulsed electromagnetic field, Visual analogue scale, diclofenac tablets |
| Visual analogue scalea graphic rating scale | Diagnostic test | Menstrual symptom questionnaire, Progesterone blood level, Pulsed electromagnetic field, Visual analogue scale, diclofenac tablets |
| Progesterone blood levelblood test | Diagnostic test | Menstrual symptom questionnaire, Progesterone blood level, Pulsed electromagnetic field, Visual analogue scale, diclofenac tablets |
| Menstrual symptom questionnairequestionnaire | Diagnostic test | Menstrual symptom questionnaire, Progesterone blood level, Pulsed electromagnetic field, Visual analogue scale, diclofenac tablets |
Primary outcome
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.
2 secondary outcomes
Progesterone blood level
Time frame: three months
Menstrual symptom questionnaire
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Individual participant dataSharing planned: Yes. Electromagnetic field versus diclofenac drugs on primary dysmenorrhea: Arandomized controlled trial in the Egyptian women
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed electromagnetic field, diclofenac tablets and Visual analogue scale in people with Electromagnetic Field and Dysmenorrhea, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.