DysmenorrheaNCT04359381
Kinesiotaping Versus Pilate Exercises
A study testing kinesiotaping application and Pilate exercises program in people with Dysmenorrhea and Exercise, run by Cairo University at 1 site in Egypt.
Trial summary
Sixty girls participated in this study and their main complaints were pain and cramping during menstruation. They were divided randomly into two equal groups. Read more about this study
- Who is it for?
- Ages 14 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea, Exercise
- What is being tested?
- kinesiotaping application and Pilate exercises program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Dec 2019to 30 Mar 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 14 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Their ages ranged from 14 to 20 years old
- their body mass index (BMI) would be less than 25 Kg/m2
- having primary dysmenorrhoea
Who cannot join
- skin diseases or cardiac diseases
- irregular or infrequent menstrual cycles
- previous abdominal or back operations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinesiotaping Versus Pilate Exercises on Primary Dysmenorrhea
Sixty girls participated in this study and their main complaints were pain and cramping during menstruation. They were divided randomly into two equal groups.
Read the detailed description
Group (A) (30 girls) treated by kinesiotaping during menstruation for 3 successive menstruation. Group (B) (30 girls) treated by pilate exercises, 3 sessions per week for 3 months except the days of menstruation. Visual analogue scale to assess pain intensity, Quality of life enjoyment and satisfaction questionnaire, Menstrual Distress Questionnaire, WALIDD score, Spielberger questionnaire and blood sample analysis to estimate plasma prostaglandin level were applied for each girl in both groups before and after the treatment course.
- Conditions
- Dysmenorrhea, Exercise
- Being tested
- kinesiotaping application, Pilate exercises program
- Keywords
- kinesiotaping, pilate exercises, primary dysmenorrhea
- Medical subject headings
- Dysmenorrhea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesiotaping applicationOther
kinesiotaping was applied once the menstrual pain begins (one day before menstruation) for periods of 4 to 5 days until the pain disappears and then removed it. Kinesiotaping was used for 3 successive menstruations.
Pilate exercises programOther
Each girl in group (B) was engaged in a supervised pilate exercises program for 30 minutes per session for 3 days/week for 12 weeks except days of menstruation. Participants would be oriented to wear comfortable clothes .
| Study group | Role | What they receive |
|---|---|---|
| kinesiotaping | Experimental | by kinesiotaping during menstruation for 3 successive menstruation Receives: Other: kinesiotaping application |
| pilate exercises | Experimental | pilate exercises, 3 sessions per week for 3 months Receives: Other: Pilate exercises program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight and height scale
Was used to measure the weight and height of each girl before starting the study and to calculate BMI according to the following formula: BMI = weight (kg) / height square (m)2
Measured: three months
Secondary outcomes (1)
Visual analog scale
For determining pain intensity before and after the treatment course for each girl in both groups (A\&B). VAS is a-10 cms line, at one end was written (no pain = zero) and at the other end was written (worst pain the patient ever felt = 10)
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 posted24 Apr 2020
- Study start24 Dec 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- The study was designed as a randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Amira Hassan Abdelaziz, Soheir Mahmoud El-Kosery
- Responsible party
- Principal investigator, Ghada Ebrahim El Refaye, Cairo University
- Investigators
- ghada eb elrefaye, professor, Principal investigator, Assistant Professor of Physical Therapy for Woman's Health, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359381
- Sponsor's protocol ID
- 90
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinesiotaping Versus Pilate Exercises on Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT04359381
- Acronym / sponsor ID
- 90
- Conditions
- Dysmenorrhea, Exercise
- Keywords
- kinesiotaping, pilate exercises, primary dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Amira Hassan Abdelaziz, Soheir Mahmoud El-Kosery
- Study start
- 24 Dec 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 24 Apr 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.
Sixty girls participated in this study and their main complaints were pain and cramping during menstruation. They were divided randomly into two equal groups.
Detailed description
Group (A) (30 girls) treated by kinesiotaping during menstruation for 3 successive menstruation. Group (B) (30 girls) treated by pilate exercises, 3 sessions per week for 3 months except the days of menstruation. Visual analogue scale to assess pain intensity, Quality of life enjoyment and satisfaction questionnaire, Menstrual Distress Questionnaire, WALIDD score, Spielberger questionnaire and blood sample analysis to estimate plasma prostaglandin level were applied for each girl in both groups before and after the treatment course.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study was designed as a randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| kinesiotaping | Experimental | Other: kinesiotaping applicationby kinesiotaping during menstruation for 3 successive menstruation |
| pilate exercises | Experimental | Other: Pilate exercises programpilate exercises, 3 sessions per week for 3 months |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Their ages ranged from 14 to 20 years old
- their body mass index (BMI) would be less than 25 Kg/m2
- having primary dysmenorrhoea
Key exclusion criteria (3 listed)
- skin diseases or cardiac diseases
- irregular or infrequent menstrual cycles
- previous abdominal or back operations
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 |
|---|---|---|
| kinesiotaping applicationkinesiotaping was applied once the menstrual pain begins (one day before menstruation) for periods of 4 to 5 days until the pain disappears and then removed it. Kinesiotaping was used for 3 successive menstruations. | Other | kinesiotaping |
| Pilate exercises programEach girl in group (B) was engaged in a supervised pilate exercises program for 30 minutes per session for 3 days/week for 12 weeks except days of menstruation. Participants would be oriented to wear comfortable clothes . | Other | pilate exercises |
Primary outcome
Weight and height scale
Time frame: three months
Was used to measure the weight and height of each girl before starting the study and to calculate BMI according to the following formula: BMI = weight (kg) / height square (m)2
1 secondary outcome
Visual analog scale
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 24 Apr 2020.
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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
Assistant Professor of Physical Therapy for Woman's Health, 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 kinesiotaping application and Pilate exercises program in people with Dysmenorrhea and Exercise, 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 24 Apr 2020. 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?
Weight and height 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 24 Apr 2020.