- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06051435
Effect of Lumbar Proprioception Training on Primary Dysmenorrhea
Effect of Lumbar Proprioception Training on Primary Dysmenorrhea: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Giza, Egypt
- Doaa Osman
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All females will have moderate to severe primary dysmenorrhea (as determined by WaLIDD Scale).
- Their ages will range from 18 to 22 years old.
- All females will be virginal and non-smokers.
- Their BMI will be range from 20-25 kg/m2
- They have regular menstrual cycle with menstrual cycle length of 28-30 days.
- They have persistent primary dysmenorrhea of more than 6 months
Exclusion Criteria:
- They shouldn't have musculoskeletal or neurological disorders, chronic LBP or sacroiliac dysfunction, diabetes, pelvic pathology or any gynecological disease.
- They shouldn't experience a stressful event in the last 6 month.
- Attending regular exercise training in the last 6 months.
- Taking medications or vitamin and mineral supplements due to other medical conditions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
They will receive hot packs and pelvic rocking exercises for one menstrual cycle.
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hot application in the form of hot packs on the lower abdomen and lower back for a total duration of 30 minutes, once per day, during the first two days of menstruation
Pelvic rocking exercise
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Experimental: Lumbar proprioception group
They will receive the same lumbar proprioception training plus hot packs and pelvic rocking exercises for one menstrual cycle.
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hot application in the form of hot packs on the lower abdomen and lower back for a total duration of 30 minutes, once per day, during the first two days of menstruation
Pelvic rocking exercise
a) Sensorimotor training: Sensorimotor training and reconditioning of proprioceptive senses have recently been found to be helpful in increasing motor performance and coordination, muscle strength, sensorimotor abilities, increasing intermuscular control, and improving one's response to sensory information and muscle tone. Reconditioning of proprioceptive senses and sensorimotor training increases one's muscle adjustment ability, maximizes the sensory input in different parts of the body and aids in improving one's motor adjustment ability (Hwang et al ., 2013). Position Exercise methods as Hollowing exercise: Participants will be asked to contract the abdominal muscles, raising the center of movement toward the navel in a quadruped position.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of lumbar proprioception
Time Frame: 4 weeks
|
It will be evaluated through Biodex system in both groups before and after treatment program through measuring the lumbar repositioning accuracy.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calculation of score of WaLIDD Scale
Time Frame: 4 weeks
|
It will be used to identify dysmenorrhea severity in both groups before and after treatment program through measuring combination of manifestations: subjective (intensity/Wong-Baker, work ability) and objective (days of pain, location) for both groups.The total score of 0 indicates without dysmenorrhea; 1-4 indicates mild dysmenorrhea, 5-7 indicates moderate dysmenorrhea, 8-12 indicates severe dysmenorrhea (Teherán et al., 2018).
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4 weeks
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lumbar curvature angle
Time Frame: 4 weeks
|
it will be measured by Flexible ruler which is affected by the tilt of the pelvis, in both groups before and after treatment program.
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: doaa osman, assis.prof, study principle investigator
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004410
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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