Pain Pressure Threshold Values Versus the Biomechanical-Viscoelastic Findings of L4-5 Supraspinous Ligament in Women Who Underwent Cesarean Delivery With Spinal Anaesthesia

NCT05367323 | Completed

• 1 other identifier: Algometry VS Myoton PRO
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Cesarean delivery is a major obstetric surgery that aims to save the lives of mothers and their neonates from complications that may be related to high-risk pregnancy and difficult delivery (Teguete et al., 2012). According to the updated Egyptian demographic and health survey, the rate of cesarean delivery in Egypt has increased until it reached about 52 % of all deliveries (Abdel-Tawab et al., 2018). Neuraxial anesthesia, especially spinal anaesthesia has been and continues to be the gold standard anesthesia for cesarean section (Mhyre and Sultan., 2019).

Conditions

Low Back Biomechanical Dysfunctions

Outcome Measures

Primary Outcomes (1)

• L4-5 Supraspinous Ligament Pain pressure threshold in Pounds

  The PPT is a quantitative sensory value for tissue sensitivity that is defined as the smallest amount of pressure that causes pain

  Assessment will be done 6-12 weeks after the use of anaesthesia during Cesarean section

Secondary Outcomes (3)

• L4-5 supraspinous ligament Stiffness in Newton/meter

  Assessment will be done 6-12 weeks after the use of anaesthesia during Cesarean section

• L4-5 supraspinous ligament Stress Relaxation Time in milliseconds

  Assessment will be done 6-12 weeks after the use of anaesthesia during Cesarean section

• L4-5 supraspinous ligament Creep in Deborah number

  Assessment will be done 6-12 weeks after the use of anaesthesia during Cesarean section

Study Arms (2)

Group A

22 women who underwent cesarean delivery using spinal anesthesia

Device: Pressure algometry (Baseline 2.2-Pound Dolorimeter) and Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)

Group B

22 women who were in the control group (they never experience pregnancy, or anaesthesia)

Device: Pressure algometry (Baseline 2.2-Pound Dolorimeter) and Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)

Interventions

Pressure algometry (Baseline 2.2-Pound Dolorimeter) and Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia) DEVICE

Both instruments are used for the assessment of the L4-5 interspinous space pain pressure threshold and the biomechanical-viscoelastic properties of L4-5 supraspinous ligament respectively

Also known as: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: All participants were females as this study related to the Department of Physical Therapy for Women's Health
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Retrospective Cohort Study in which 44 women participated in this study. They were selected from South Valley University Teaching Hospitals.

You may qualify if:

• All women in the epidural and spinal anesthetic groups gave birth through a cesarean delivery.
• All women either primiparous or multiparous have not had anesthesia (epidural, spinal ) for at least one year prior to the last obstetric anesthesia.
• 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.

You may not qualify if:

• Women who delivered through vaginal delivery.
• Women who delivered through cesarean delivery, but the used anesthetic technique was the paramedian approach of spinal anesthesia.
• Women with urinary tract infections and diastasis recti.
• Women who were below 18 years old or above 35 years old.
• Women who had (BMI) above 30 or waist to hip ratio above 1.
• Women who did not continue all assessment procedures.
• Women who had any non-myofascial low back dysfunctions as women who were diagnosed with lumbar disc prolapse or spondylolisthesis.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Faculty of physical therapy, South Valley University

Qina, Qena Governorate, 83523, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Physical Therapy for Women's Health

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 10, 2022
• Study Start: June 28, 2021
• Primary Completion: January 29, 2022
• Study Completion: April 15, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

EG (1)