- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06031649
Lumbar Paraspinal Muscular Properties After Cesarean Delivery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stiffness and elasticity are two mechanical characteristics of the muscles, whereas relaxation time and creeping are two viscoelastic characteristics.
Different studies investigated the mechanical properties of lumbar paraspinal muscles in numerous musculoskeletal conditions, however, no previous studies investigated these characteristics after cesarean section, which is associated with high prevalence of lower back pain when compared with normal delivery.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Qena
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Qinā, Qena, Egypt, 83523
- Faculty of physical therapy, South Valley University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women who experienced cesarean section at least for one time
- Women Who are free of specific lower back disorders
- Women who are below 34 years old and above 20 years old
Exclusion Criteria:
- Women who experienced normal vaginal birth
- Women who complain of a specific lower back disorder
- Women who are above 34 years old or below 20 years old
- Women who have a body mass index above 30 Kg/m2
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Group A
30 mother underwent cesarean section
|
It is a valid and reliable device for measuring the muscular mechanical properties
Other Names:
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Group B
30 healthy females who were in the control group
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It is a valid and reliable device for measuring the muscular mechanical properties
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lumbar Paraspinal Muscles Stiffness, measured by the MyotonPRO device in units of N/m.
Time Frame: 6-12 weeks after cesarean section
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muscular stiffness refers to muscle resistance against forces that deform it.
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6-12 weeks after cesarean section
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Lumbar Paraspinal Muscles Elasticity, measured by the MyotonPRO device in a relative unit
Time Frame: 6-12 weeks after cesarean section
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Muscular Elasticity refers to the muscular ability to return to its original shape after the removal of tensional forces.
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6-12 weeks after cesarean section
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lumbar Paraspinal Muscles Stress Relaxation Time, measured by the MyotonPRO device in milliseconds
Time Frame: 6-12 weeks after cesarean section
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relaxation time is a viscoelastic characteristic of the muscles, it refers to the time taken to return to the original shape after the removal of the deformative forces.
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6-12 weeks after cesarean section
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Lumbar Paraspinal Muscles Creep, measured by the MyotonPRO device in a relative unit
Time Frame: 6-12 weeks after cesarean section
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Muscular creep refers to the muscular ability to lengthen when constant stresses applied to it.
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6-12 weeks after cesarean section
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Struzik A, Karamanidis K, Lorimer A, Keogh JWL, Gajewski J. Application of Leg, Vertical, and Joint Stiffness in Running Performance: A Literature Overview. Appl Bionics Biomech. 2021 Oct 21;2021:9914278. doi: 10.1155/2021/9914278. eCollection 2021.
- Van Deun B, Hobbelen JSM, Cagnie B, Van Eetvelde B, Van Den Noortgate N, Cambier D. Reproducible Measurements of Muscle Characteristics Using the MyotonPRO Device: Comparison Between Individuals With and Without Paratonia. J Geriatr Phys Ther. 2018 Oct/Dec;41(4):194-203. doi: 10.1519/JPT.0000000000000119.
- Parikh S, Suchi J. Prevalence of low back pain and its impact on quality of life in post-partum women. International Journal of Scientific Research. 2016; 7:14342-8.
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
- Lumbar Paraspinal Muscles
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
product manufactured in and exported from the U.S.
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