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CompletedNCT05503758Updated Oct 2, 2025

Biomechanical Properties of the Lumbar Paravertebral Muscles

An observational study in Lumbar Paravertebral Muscles, sponsored by South Valley University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2025-10-02.

Sponsored by South Valley University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
63
Ages
18 Years to 35 Years
Sex
Female
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Study summary

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.

Read the 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.

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Conditions studied

  • Lumbar Paravertebral Muscles
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In context

Lead sponsor

South Valley University is the lead sponsor of 147 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

Sixty-three women participated in this study and were recruited from South Valley University Teaching Hospitals, in Qena governorate, Egypt.

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

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.
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
63 participants (actual)
Patient registry
No

Groups and cohorts

  • Group A

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

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

  • Group B

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

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

  • Group C

    10 participants underwent general anesthesia for cesarean delivery.

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

  • Group D

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

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

Interventions

  • DeviceMyoton 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).

    Also known as: Myotonometry

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What researchers measure

Primary outcomes

  1. Lumbar paravertebral muscle frequency (tone)

    Tone is a contractile property of a muscle which describes the resting muscle's resistance to passive and active stretch forces

    Time frame: Assessment will be done 6-12 weeks after the use of anaesthesia for Cesarean section by the MyotonPRO device

  2. Lumbar paravertebral muscle stiffness

    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

    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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Study locations

1 site
  • Faculty of physical therapy, South Valley University
    Qina, Qena Governorate 83523, Egypt
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References and documents

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. PubMed 30985305 ↗
  • Lenhardt R. Body temperature regulation and anesthesia. Handb Clin Neurol. 2018;157:635-644. doi: 10.1016/B978-0-444-64074-1.00037-9. PubMed 30459029 ↗
  • 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. PubMed 34721664 ↗
  • 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. PubMed 28005829 ↗
  • 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. PubMed 31151377 ↗
  • 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. PubMed 35248290 ↗
  • 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. PubMed 31759390 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05503758
Lead sponsor
South Valley University
Responsible party
Mohamed Gamal Abouelyazeed Ali (Assistant Lecturer of Physical Therapy for Women's Health, South Valley University) — Principal investigator
First posted
Aug 17, 2022
Start date
Jun 28, 2021
Primary completion
Jan 29, 2022
Completion
Jan 29, 2022
Last update
Oct 2, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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