Dysmenorrhea PrimaryEarly Phase 1KAUNCT06808529
Effect of Pilates Exercises and TENS Acupuncture in Primary Dysmenorrhea Among Female Students At KAU
A Early Phase 1 study testing Pilates exercises and TENS Acupuncture and ibuprofen 400 mg in people with Dysmenorrhea Primary, run by Cairo University at 1 site in Saudi Arabia.
Trial summary
This study was done to determine the effect of Pilates exercises and TENS acupuncture in primary dysmenorrhea among female students at King Abdulaziz University (KAU). Read more about this study
- Who is it for?
- Ages 18 to 24 years, women only
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Pilates exercises and TENS Acupuncture and ibuprofen 400 mg
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 30 Jan 2024to 30 Sep 2024
- Phase
- Early Phase 1
- 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 24 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participants suffering from primary dysmenorrhea.
- Their age ranged between 18-24 years
- Their BMI less than 30 kg/m2.
Who cannot join
- Gynecological disorders (secondary dysmenorrhea)
- Married females,
- Low back pain due to any other pathology
- Chronic diseases (diabetes, high blood pressure)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Effectiveness of Pilates and TENS Acupuncture in Treating Primary Dysmenorrhea in Female Students At King Aboulaziz University (KAU)
This study was done to determine the effect of Pilates exercises and TENS acupuncture in primary dysmenorrhea among female students at King Abdulaziz University (KAU).
- Conditions
- Dysmenorrhea Primary
- Being tested
- Pilates exercises and TENS Acupuncture, ibuprofen 400 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercises and TENS AcupunctureDevice
All performed Pilates exercises for 24 session, 3 sessions per week for (2 consecutive menstrual cycle), each session lasted for 30 minutes in addition to application of TENS acupuncture therapy for 30 minutes, 3 sessions in the first 3 days for (2 consecutive menstrual cycle).
ibuprofen 400 mgDrug
All took capsules of ibuprofen(400-milligram) and instructed to take them once every eight hours for three days, one day before the start of their menstrual cycle and on the first two days of menstruation for (2 consecutive menstrual cycle).
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Pilates exercises and TENS Acupuncture Receives: Device: Pilates exercises and TENS Acupuncture |
| Control group | Experimental | Conservative treatment Receives: Drug: ibuprofen 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue scale
Visual Analogue scale for assessing pain level, a score ranging from 0 to 100 mm.
Measured: 2 months
Secondary outcomes (1)
Verbal multidimensional scoring system of dysmenorrhea
- Grade 0: The menstrual cycle causes no pain and has no effect on day-to-day activities.
- Grade 1: Although uncomfortable menstruation never gets in the way of a woman's regular activities, and analgesics are rarely needed.
- Grade 2 : daily activities are disrupted and analgesics have a poor effect .
- Grade 3: Activity is obviously impeded, analgesics have a poor effect and symptoms such as headache, fatigue, nausea, vomiting, and diarrhea is present
Measured: 2 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 2025
- Study start30 Jan 2024
- Primary completion30 May 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engy Mohamed Elnahas, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808529
- Sponsor's protocol ID
- FMRS-EC2024-030
- Acronym
- KAU
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effectiveness of Pilates and TENS Acupuncture in Treating Primary Dysmenorrhea in Female Students At King Aboulaziz University (KAU)
- ClinicalTrials.gov ID
- NCT06808529
- Acronym / sponsor ID
- KAU / FMRS-EC2024-030
- Conditions
- Dysmenorrhea Primary
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 5 Feb 2025 (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 done to determine the effect of Pilates exercises and TENS acupuncture in primary dysmenorrhea among female students at King Abdulaziz University (KAU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Pilates exercises and TENS AcupuncturePilates exercises and TENS Acupuncture |
| Control group | Experimental | Drug: ibuprofen 400 mgConservative treatment |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants suffering from primary dysmenorrhea.
- Their age ranged between 18-24 years
- Their BMI less than 30 kg/m2.
Key exclusion criteria (4 listed)
- Gynecological disorders (secondary dysmenorrhea)
- Married females,
- Low back pain due to any other pathology
- Chronic diseases (diabetes, high blood pressure)
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 |
|---|---|---|
| Pilates exercises and TENS AcupunctureAll performed Pilates exercises for 24 session, 3 sessions per week for (2 consecutive menstrual cycle), each session lasted for 30 minutes in addition to application of TENS acupuncture therapy for 30 minutes, 3 sessions in the first 3 days for (2 consecutive menstrual cycle). | Device | Study group |
| ibuprofen 400 mgAll took capsules of ibuprofen(400-milligram) and instructed to take them once every eight hours for three days, one day before the start of their menstrual cycle and on the first two days of menstruation for (2 consecutive menstrual cycle). | Drug | Control group |
Primary outcome
Visual Analogue scale
Time frame: 2 months
Visual Analogue scale for assessing pain level, a score ranging from 0 to 100 mm.
1 secondary outcome
Verbal multidimensional scoring system of dysmenorrhea
Time frame: 2 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 5 Feb 2025.
- articleLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 Early Phase 1 study testing Pilates exercises and TENS Acupuncture and ibuprofen 400 mg in people with Dysmenorrhea Primary, run by Cairo University at 1 site in Saudi Arabia.
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 4 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 5 Feb 2025. 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 Saudi Arabia. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: 2 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 5 Feb 2025.