Biomechanical Properties of the Lumbar Paravertebral Muscles

NCT ID: NCT05503758

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-28

Study Completion Date

2022-01-29

Brief Summary

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Cesarean delivery (CD) is an obstetric surgery for fetal delivery that involves both an abdominal incision (laparotomy) and a uterine incision (hysterotomy). It is presently the most prevalent surgery in the United States, with over 1 million women giving birth by cesarean section each year.

Detailed Description

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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.

Conditions

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Lumbar Paravertebral Muscles

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group A

9 participants have exposed to midline epidural anaesthesia for cesarean delivery.

Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)

Intervention Type DEVICE

The MyotoPRO device is a portable objective device for measuring the contractile (tone), and biomechanical (stiffness) properties of lumbar paravertebral muscles (LPVMs).

Group B

22 participants have exposed to midline spinal anaesthesia for cesarean delivery.

Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)

Intervention Type DEVICE

The MyotoPRO device is a portable objective device for measuring the contractile (tone), and biomechanical (stiffness) properties of lumbar paravertebral muscles (LPVMs).

Group C

10 participants underwent general anesthesia for cesarean delivery.

Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)

Intervention Type DEVICE

The MyotoPRO device is a portable objective device for measuring the contractile (tone), and biomechanical (stiffness) properties of lumbar paravertebral muscles (LPVMs).

Group D

22 participants were in the control group (no previous pregnancy or anaesthesia).

Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)

Intervention Type DEVICE

The MyotoPRO device is a portable objective device for measuring the contractile (tone), and biomechanical (stiffness) properties of lumbar paravertebral muscles (LPVMs).

Interventions

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Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)

The MyotoPRO device is a portable objective device for measuring the contractile (tone), and biomechanical (stiffness) properties of lumbar paravertebral muscles (LPVMs).

Intervention Type DEVICE

Other Intervention Names

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Myotonometry

Eligibility Criteria

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Inclusion Criteria

1. All women gave birth through a cesarean delivery.
2. 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.
3. Their ages ranged from 18 to 35 years.
4. All participants had a body mass index (BMI) of not more than 30, and a waist-to-hip ratio of not more than 1.
5. Participants were assessed between the 6th week to the 12th week postnatal.
6. All participants were able to continue all assessment procedures.
7. They were medically stable.

Exclusion Criteria

1. Women who delivered through vaginal delivery.
2. Women who delivered through cesarean delivery, but the used anaesthetic technique was the paramedian approach for either the epidural or spinal anaesthesia.
3. Women with urinary tract infections.
4. Women who were below 18 years old or above 35 years old.
5. Women who had a (BMI) above 30 or a waist-to-hip ratio above 1.
6. Women who did not continue all assessment procedures.
7. Women who had any specific low back pain as women who were diagnosed with lumbar disc prolapse, scoliosis, or spondylolisthesis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Gamal Abouelyazeed Ali

Assistant Lecturer of Physical Therapy for Women's Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of physical therapy, South Valley University

Qina, Qena Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 30985305 (View on PubMed)

Lenhardt R. Body temperature regulation and anesthesia. Handb Clin Neurol. 2018;157:635-644. doi: 10.1016/B978-0-444-64074-1.00037-9.

Reference Type BACKGROUND
PMID: 30459029 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34721664 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28005829 (View on PubMed)

Sung, S., and Mahdy, H. (2021):

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 31151377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35248290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31759390 (View on PubMed)

Other Identifiers

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Lumbar Paravertebral muscles

Identifier Type: -

Identifier Source: org_study_id

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