Primary DysmenorrheaNCT04741243
Effect of Extracorporeal Shock Therapy for Dysmenorrhea
A study testing Extracorporeal Shock wave in people with Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
Trial summary
This study was carried out upon forty women diagnosed as primary dysmenorrhea. They were selected from outpatient clinics of gynecology of Ain Shams University Hospital, Cairo University. Their age ranged from 25-35 years, BMI<30kg/ m². Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Extracorporeal Shock wave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jun 2019to 1 Dec 2020
- 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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- forty virgin females.
- their age ranged between 25 to 35 years old.
- Body mass index (BMI) <30kg/ m².
Who cannot join
- females with pelvic pathology as endometriosis.
- females have irregular menstrual cycles.
- females have secondary dysmenorrhea.
Trial locations and contacts
1 site in 1 country.
About this study
This study was carried out upon forty women diagnosed as primary dysmenorrhea. They were selected from outpatient clinics of gynecology of Ain Shams University Hospital, Cairo University. Their age ranged from 25-35 years, BMI<30kg/ m².
Read the detailed description
Patients with primary dysmenorrhea diagnosed by a physician, spondylolisthesis and chronic low back pain were excluded from the study. They were randomly assigned into two equal groups (A\& B). Group (A) consisted of twenty subjects, with an average age 29.2±1.9Yrs, and BMI 27.28±2.1kg/m2 who received Extracorporeal shock waves. Group (B) consisted of twenty patients, with an average age 28.58±2.2Yrs, and BMI 28.92±0.7kg/m2 who received sham technique. A hot pack was used for 15 minutes for both groups (A\&B) before the treatment.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Extracorporeal Shock wave
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock waveDevice
Also called dietary modification
Dietary modifications are changes made during food preparation, processing, and consumption to increase the bioavailability of micronutrients-and reduce micronutrient deficiencies-in food at the commercial or individual/household level
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal shock wave therapy | Experimental | was used for 15 minutes in a prone position for both groups (A\&B) before the treatment. shock wave were used to heat small areas, and allow for decrease pain, muscle spasm, and provide vasodilatation of the blood vessels supplying the area Receives: Device: Extracorporeal Shock wave |
| dietary modification | Experimental | Dietary modifications are changes made during food preparation, processing, and consumption to increase the bioavailability of micronutrients-and reduce micronutrient deficiencies-in food at the commercial or individual/household level. Receives: Device: Extracorporeal Shock wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Visual analogue scale: that was used to determine the pain intensity level. It consists of 10 cm as a horizontal line with one end represented that (0= no pain) and the other end (10= worst pain). The assessment was performed for every woman in both groups (A, B) before and after the treatment program.
Measured: three months
Secondary outcomes (1)
analysis of circulating β-endorphin
assessment of circulating β-endorphin was done before and after the treatment progam
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 posted5 Feb 2021
- Study start24 Jun 2019
- Primary completion30 Nov 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies 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
- Collaborators
- Shaimaa Mohamed Hamed
- Responsible party
- Principal investigator, Ghada Ebrahim El Refaye, Cairo University
- Investigators
- ghada eb elrefaye, professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741243
- Sponsor's protocol ID
- Cairo Un 99
- Status last verified
- Mar 2021
- First submitted
- 2 Feb 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extracorporeal Shock Therapy for Dysmenorrhea
- ClinicalTrials.gov ID
- NCT04741243
- Acronym / sponsor ID
- Cairo Un 99
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Shaimaa Mohamed Hamed
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 5 Feb 2021 (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.
This study was carried out upon forty women diagnosed as primary dysmenorrhea. They were selected from outpatient clinics of gynecology of Ain Shams University Hospital, Cairo University. Their age ranged from 25-35 years, BMI<30kg/ m².
Detailed description
Patients with primary dysmenorrhea diagnosed by a physician, spondylolisthesis and chronic low back pain were excluded from the study. They were randomly assigned into two equal groups (A\& B). Group (A) consisted of twenty subjects, with an average age 29.2±1.9Yrs, and BMI 27.28±2.1kg/m2 who received Extracorporeal shock waves. Group (B) consisted of twenty patients, with an average age 28.58±2.2Yrs, and BMI 28.92±0.7kg/m2 who received sham technique. A hot pack was used for 15 minutes for both groups (A\&B) before the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal shock wave therapy | Experimental | Device: Extracorporeal Shock wavewas used for 15 minutes in a prone position for both groups (A\&B) before the treatment. shock wave were used to heat small areas, and allow for decrease pain, muscle spasm, and provide vasodilatation of the blood vessels supplying the area |
| dietary modification | Experimental | Device: Extracorporeal Shock waveDietary modifications are changes made during food preparation, processing, and consumption to increase the bioavailability of micronutrients-and reduce micronutrient deficiencies-in food at the commercial or individual/household level. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- forty virgin females.
- their age ranged between 25 to 35 years old.
- Body mass index (BMI) <30kg/ m².
Key exclusion criteria (3 listed)
- females with pelvic pathology as endometriosis.
- females have irregular menstrual cycles.
- females have secondary dysmenorrhea.
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 |
|---|---|---|
| Extracorporeal Shock waveAlso: dietary modificationDietary modifications are changes made during food preparation, processing, and consumption to increase the bioavailability of micronutrients-and reduce micronutrient deficiencies-in food at the commercial or individual/household level | Device | Extracorporeal shock wave therapy, dietary modification |
Primary outcome
Visual Analogue Scale
Time frame: three months
Visual analogue scale: that was used to determine the pain intensity level. It consists of 10 cm as a horizontal line with one end represented that (0= no pain) and the other end (10= worst pain). The assessment was performed for every woman in both groups (A, B) before and after the treatment program.
1 secondary outcome
analysis of circulating β-endorphin
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 11 Mar 2021.
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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.
ghada eb elrefaye, professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock wave in people with Primary Dysmenorrhea, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 3 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 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 11 Mar 2021.