Biomechanical Properties of the Lumbar Paravertebral Muscles

Completed

• Conditions: Lumbar Paravertebral Muscles
• Interventions: Device: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)

• Registration Number: NCT05503758
• Lead Sponsor: South Valley University

Brief 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.

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 Timeline

• Study Start: 2021-06-28
• Primary Completion: 2022-01-29
• Study Completion: 2022-01-29
• Study First Submitted: 2022-08-13
• Study First Submitted QC: 2022-08-13
• Study First Posted: 2022-08-17
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group C	Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)	10 participants underwent general anesthesia for cesarean delivery.
Group A	Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)	9 participants have exposed to midline epidural anaesthesia for cesarean delivery.
Group D	Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)	22 participants were in the control group (no previous pregnancy or anaesthesia).
Group B	Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)	22 participants have exposed to midline spinal anaesthesia for cesarean delivery.

Primary Outcome Measures

Name	Time	Method
Lumbar paravertebral muscle stiffness	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
Lumbar paravertebral muscle frequency (tone)	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

Trial Locations

Locations (1)

Faculty of physical therapy, South Valley University; 🇪🇬 Qinā, Qena, Egypt