Primary DysmenorrheaNCT04662814
Extracorporeal Shock Wave Therapy for Dysmenorrhea
A study testing shock wave therapy and dietary modification in people with Primary Dysmenorrhea, run by MTI University at 1 site in Egypt.
Trial summary
purpose of this study to investigate the effect of Extracorporeal shock wave therapy on pain and prostaglandin level in patient with primary dysmenorrhea Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- shock wave therapy and dietary modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Sep 2020to 27 Jan 2021
- 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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages ranged between18 - 25 years old.
- body mass index (BMI) will not exceed 30kg/m2.
- females will be diagnosed by the physician as primary dysmenorrhea.
Who cannot join
- Secondary dysmenorrhea .
- Mental health problem such as depression and anxiety.
- Irregular periods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Efficacy of Extracorporeal Shock Wave Therapy for Primary Dysmenorrhea
purpose of this study to investigate the effect of Extracorporeal shock wave therapy on pain and prostaglandin level in patient with primary dysmenorrhea
Read the detailed description
This randomized controlled trial is to determine the effect of shock wave therapy in the treatment of primary dysmenorrhea.
females are randomly assigned into 2 groups: group A SWT treatment plus dietary modification during PD (n=25） GROUP B:dietary modification only (n=25）;
Participants in group B will receive dietary modification for three successive months
The numerical rating scale (NRS) and prostaglandin blood level will be recorded and evaluated before and after treatment.
- Conditions
- Primary Dysmenorrhea
- Being tested
- shock wave therapy, dietary modification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shock wave therapyOther
Intervention group is by shock wave therapy. A radial shock wave device (EME, ITALY) was used. for 4 sessions (one session before the expected day of period and session per day for day1 , day 2 and day 3 of each menstrual cycle) for three successive periods.
dietary modificationOther
Participants will receive dietary modification for three consecutive months dietary modification will be low caffeine and high water and liquids intake and reduce the uptake of fast food, should be followed for 3 months
| Study group | Role | What they receive |
|---|---|---|
| shock wave | Experimental | shock wave for primary dysmenorrhea for study group along side to dietary modification Receives: Other: shock wave therapy; Other: dietary modification |
| dietary modification | Active comparator | dietary modification for primary dysmenorrhea for control group Receives: Other: dietary modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating scale
Numeric rating scale will be 10 cm digital line with 0 (zero) representing feeling no pain and 10 representing feeling the worst pain, was used to assess the severity of the pain before and after treatment for all females in both groups (A\&B).
measurement will done twice first one at baseline(will be considered as pre treatment measure) and 2nd on e at 3rd menstrual cycle ( will be considered as post treatment measure)
Measured: 3 months
Secondary outcomes (1)
prostaglandin
5cm plasma concentrations of prostaglandin F2α was taken from all females and was analyzed in the Laboratory index to determine the prostaglandin plasma level
measurement will done twice before after the treatment program.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start12 Sep 2020
- Primary completion24 Dec 2020
- Study completion27 Jan 2021
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.
- 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
- Model description
- group A: shockwave therapy and dietary modification group B: dietary modification
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Collaborators
- Ghada ebrahim El Refaye -Faculty of Physical Therapy, Cairo University, Egypt, Cairo University
- Responsible party
- Principal investigator, shaimaa Mohamed hamed, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662814
- Sponsor's protocol ID
- mtiu
- Status last verified
- Mar 2021
- First submitted
- 22 Nov 2020
- Last updated
- 24 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 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Efficacy of Extracorporeal Shock Wave Therapy for Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT04662814
- Acronym / sponsor ID
- mtiu
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Collaborators
- Ghada ebrahim El Refaye -Faculty of Physical Therapy, Cairo University, Egypt, Cairo University
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 10 Dec 2020 (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.
purpose of this study to investigate the effect of Extracorporeal shock wave therapy on pain and prostaglandin level in patient with primary dysmenorrhea
Detailed description
This randomized controlled trial is to determine the effect of shock wave therapy in the treatment of primary dysmenorrhea.
females are randomly assigned into 2 groups: group A SWT treatment plus dietary modification during PD (n=25） GROUP B:dietary modification only (n=25）;
Participants in group B will receive dietary modification for three successive months
The numerical rating scale (NRS) and prostaglandin blood level will be recorded and evaluated before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- group A: shockwave therapy and dietary modification group B: dietary modification
| Arm | Type | Receives |
|---|---|---|
| shock wave | Experimental | Other: shock wave therapy, Other: dietary modificationshock wave for primary dysmenorrhea for study group along side to dietary modification |
| dietary modification | Active comparator | Other: dietary modificationdietary modification for primary dysmenorrhea for control group |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ages ranged between18 - 25 years old.
- body mass index (BMI) will not exceed 30kg/m2.
- females will be diagnosed by the physician as primary dysmenorrhea.
Key exclusion criteria (3 listed)
- Secondary dysmenorrhea .
- Mental health problem such as depression and anxiety.
- Irregular periods
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 |
|---|---|---|
| shock wave therapyIntervention group is by shock wave therapy. A radial shock wave device (EME, ITALY) was used. for 4 sessions (one session before the expected day of period and session per day for day1 , day 2 and day 3 of each menstrual cycle) for three successive periods. | Other | shock wave |
| dietary modificationParticipants will receive dietary modification for three consecutive months dietary modification will be low caffeine and high water and liquids intake and reduce the uptake of fast food, should be followed for 3 months | Other | dietary modification, shock wave |
Primary outcome
numerical rating scale
Time frame: 3 months
Numeric rating scale will be 10 cm digital line with 0 (zero) representing feeling no pain and 10 representing feeling the worst pain, was used to assess the severity of the pain before and after treatment for all females in both groups (A\&B). measurement will done twice first one at baseline(will be considered as pre treatment measure) and 2nd on e at 3rd menstrual cycle ( will be considered as post treatment measure)
1 secondary outcome
prostaglandin
Time frame: 3months
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 24 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shock wave therapy and dietary modification in people with Primary Dysmenorrhea, run by MTI 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 24 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?
numerical rating scale (time frame: 3 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 24 Mar 2021.