- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05503758
Biomechanical Properties of the Lumbar Paravertebral Muscles
Quantification of Different Lumbar Paravertebral Muscles Properties in Women Who Experienced Cesarean Delivery Under Different Types of Anaesthesia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The anaesthetic types of choice for cesarean delivery are neuraxial and general anaesthesia.
Neuraxial anesthesia is the gold standard anaesthesia for CD; it includes spinal and epidural anaesthesia. For spinal anaesthesia, local anesthetics are injected into the spinal canal, while for epidural anaesthesia, they are injected into the epidural space.
Despite the superiority of neuraxial anaesthesia for cesarean delivery, general anesthesia is still performed to some extent especially when neuraxial anaesthesia is failed or inconsistent.
General anesthesia involves a transient state of unconsciousness through the administration of inhaled anesthetic gases combined with intravenous drugs.
LBP patients showed changes in their neuromuscular activity, reduction in the lumbar muscle flexibility, and alteration of the biomechanical properties of the lumbar muscles.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Qena Governorate
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Qina, Qena Governorate, Egypt, 83523
- Faculty of physical therapy, South Valley University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All women gave birth through a cesarean delivery.
- All women either primiparous or multiparous have not had anaesthesia (epidural, spinal, or general) for at least one year prior to the last obstetric anaesthesia.
- Their ages ranged from 18 to 35 years.
- All participants had a body mass index (BMI) of not more than 30, and a waist-to-hip ratio of not more than 1.
- Participants were assessed between the 6th week to the 12th week postnatal.
- All participants were able to continue all assessment procedures.
- They were medically stable.
Exclusion Criteria:
- Women who delivered through vaginal delivery.
- Women who delivered through cesarean delivery, but the used anaesthetic technique was the paramedian approach for either the epidural or spinal anaesthesia.
- Women with urinary tract infections.
- Women who were below 18 years old or above 35 years old.
- Women who had a (BMI) above 30 or a waist-to-hip ratio above 1.
- Women who did not continue all assessment procedures.
- Women who had any specific low back pain as women who were diagnosed with lumbar disc prolapse, scoliosis, or spondylolisthesis.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Group A
9 participants have exposed to midline epidural anaesthesia for cesarean delivery.
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The MyotoPRO device is a portable objective device for measuring the contractile (tone), and biomechanical (stiffness) properties of lumbar paravertebral muscles (LPVMs).
Other Names:
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Group B
22 participants have exposed to midline spinal anaesthesia for cesarean delivery.
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The MyotoPRO device is a portable objective device for measuring the contractile (tone), and biomechanical (stiffness) properties of lumbar paravertebral muscles (LPVMs).
Other Names:
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Group C
10 participants underwent general anesthesia for cesarean delivery.
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The MyotoPRO device is a portable objective device for measuring the contractile (tone), and biomechanical (stiffness) properties of lumbar paravertebral muscles (LPVMs).
Other Names:
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Group D
22 participants were in the control group (no previous pregnancy or anaesthesia).
|
The MyotoPRO device is a portable objective device for measuring the contractile (tone), and biomechanical (stiffness) properties of lumbar paravertebral muscles (LPVMs).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Lumbar paravertebral muscle frequency (tone)
Time Frame: Assessment will be done 6-12 weeks after the use of anaesthesia for Cesarean section by the MyotonPRO device
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Tone is a contractile property of a muscle which describes the resting muscle's resistance to passive and active stretch forces
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Assessment will be done 6-12 weeks after the use of anaesthesia for Cesarean section by the MyotonPRO device
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Lumbar paravertebral muscle stiffness
Time Frame: Assessment will be done 6-12 weeks after the use of anaesthesia for Cesarean section by the MyotonPRO device
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Stiffness is a biomechanical property of a muscle and its connective tissue which refers to the tissue's resistance toward the deformation of external load
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Assessment will be done 6-12 weeks after the use of anaesthesia for Cesarean section by the MyotonPRO device
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Iddrisu M, Khan ZH. Anesthesia for cesarean delivery: general or regional anesthesia-a systematic review. Ain-Shams Journal of Anesthesiology. 2021 Dec;13(1):1-7.
- Mhyre JM, Sultan P. General Anesthesia for Cesarean Delivery: Occasionally Essential but Best Avoided. Anesthesiology. 2019 Jun;130(6):864-866. doi: 10.1097/ALN.0000000000002708. No abstract available.
- Lenhardt R. Body temperature regulation and anesthesia. Handb Clin Neurol. 2018;157:635-644. doi: 10.1016/B978-0-444-64074-1.00037-9.
- 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.
- Sung, S., and Mahdy, H. (2021):
- Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827.
- Hamilton RI, Garden CLP, Brown SJ. Immediate effect of a spinal mobilisation intervention on muscle stiffness, tone and elasticity in subjects with lower back pain - A randomized cross-over trial. J Bodyw Mov Ther. 2022 Jan;29:60-67. doi: 10.1016/j.jbmt.2021.09.032. Epub 2021 Oct 9.
- Lo WLA, Yu Q, Mao Y, Li W, Hu C, Li L. Lumbar muscles biomechanical characteristics in young people with chronic spinal pain. BMC Musculoskelet Disord. 2019 Nov 23;20(1):559. doi: 10.1186/s12891-019-2935-z.
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 (Estimated)
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 Paravertebral 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.
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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