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OpenTrials
Completed

NCT Number: NCT05503758

Biomechanical Properties of the Lumbar Paravertebral Muscles

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of physical therapy, South Valley University

Qina, Qena Governorate, 83523, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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

Other names: Myotonometry

Primary outcomes

  1. 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

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

  2. 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

    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

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study title

Quantification of Different Lumbar Paravertebral Muscles Properties in Women Who Experienced Cesarean Delivery Under Different Types of Anaesthesia

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 17, 2022
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.