- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04359381
Kinesiotaping Versus Pilate Exercises
April 21, 2020 updated by: Ghada Ebrahim El Refaye, Cairo University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 02
- Ghada Elrefaye
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Their ages ranged from 14 to 20 years old
- their body mass index (BMI) would be less than 25 Kg/m2
- having primary dysmenorrhoea
Exclusion Criteria:
- skin diseases or cardiac diseases
- irregular or infrequent menstrual cycles
- previous abdominal or back operations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: kinesiotaping
by kinesiotaping during menstruation for 3 successive menstruation
|
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.
|
Experimental: pilate exercises
pilate exercises, 3 sessions per week for 3 months
|
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 .
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog scale
Time Frame: three months
|
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)
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: ghada eb elrefaye, professor, Assistant Professor of Physical Therapy for Woman's Health, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 24, 2019
Primary Completion (Actual)
March 30, 2020
Study Completion (Actual)
March 30, 2020
Study Registration Dates
First Submitted
April 20, 2020
First Submitted That Met QC Criteria
April 21, 2020
First Posted (Actual)
April 24, 2020
Study Record Updates
Last Update Posted (Actual)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 21, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 90
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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