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NCT06031649 Clinical Trial

Lumbar Paraspinal Muscular Properties After Cesarean Delivery

Low Back Pain, Mechanical Clinical Trial

Official title:
Lumbar Paraspinal Muscular Properties After Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06031649
Other study ID # Lumbar Paraspinal Muscles
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 28, 2021
Est. completion date February 15, 2022

Study information
Verified date September 2023
Source South Valley University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The biomechanical characteristics of lumbar paraspinal muscles may give us insight into different lower back dysfunctions in postpartum mothers after cesarean section.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date February 15, 2022
Est. primary completion date January 29, 2022
Accepts healthy volunteers
Gender Female
Age group 20 Years to 34 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• MyotonPRO device
It is a valid and reliable device for measuring the muscular mechanical properties

Locations
Country Name City State
Egypt Faculty of physical therapy, South Valley University Qina Qena

Sponsors (1)
Lead Sponsor Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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.

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Lumbar Paraspinal Muscles Stiffness, measured by the MyotonPRO device in units of N/m. muscular stiffness refers to muscle resistance against forces that deform it. 6-12 weeks after cesarean section
Primary Lumbar Paraspinal Muscles Elasticity, measured by the MyotonPRO device in a relative unit Muscular Elasticity refers to the muscular ability to return to its original shape after the removal of tensional forces. 6-12 weeks after cesarean section
Secondary Lumbar Paraspinal Muscles Stress Relaxation Time, measured by the MyotonPRO device in milliseconds 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. 6-12 weeks after cesarean section
Secondary Lumbar Paraspinal Muscles Creep, measured by the MyotonPRO device in a relative unit Muscular creep refers to the muscular ability to lengthen when constant stresses applied to it. 6-12 weeks after cesarean section
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