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

Is Pain Pressure Threshold Consistent With the Biomechanical-Viscoelastic Changes for L4-5 Supraspinous Ligament in Women Undergoing Midline Spinal Anaesthesia for Cesarean Delivery

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).

Study Overview

• Status: Completed
• Conditions: Low Back Biomechanical Dysfunctions
• Intervention / Treatment: Device: Pressure algometry (Baseline 2.2-Pound Dolorimeter) and Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)

Detailed Description

Low back pain (LBP) after neuraxial anaesthesia is a typical mild intensity pain. It is thought to be caused by needle trauma and local anaesthetic myotoxicity. Post-dural puncture backache (PDPB), which is defined as a persistent pain around the puncture site without radicular pain, is a common consequence following spinal anaesthesia (Benzon et al., 2016). Back pain following anaesthesia may be attributed to ligament, fascia, or bone injuries with localized bleeding; rigidity of the spine; anaesthesia-induced relaxation of the paraspinal muscles; flattening of the typical lumbar convexity, and stretching and straining of the lumbosacral ligaments and joint capsules (Benzon et al., 2016).

Pressure algometry is an objective well-known and well-validated method which induces acute experimental pain for determining the Pain Pressure Threshold (PPT) in various parts of the body (Pelfort et al., 2015). The PPT is a quantitative sensory value for tissue sensitivity that is defined as the smallest amount of pressure that causes pain (Ylinen., 2007).

The MyotonPRO is a portable valid device for measuring the biomechanical properties such as stiffness and the viscoelasticity of the superficial myofascial tissue objectively (Nguyen et al., 2022). Stiffness, stress relaxation time and creep are biomechanical and viscoelastic properties of lower lumbar myofascia that can be measured using the MyotonPRO device either in healthy adults or low back pain patients (Ilahi et al., 2020). Also, the MyotonPRO can tell the difference between a trigger point and a non-trigger point in terms of viscoelastic qualities such as stress relaxation time or creeping through objective assessment (Roch et al., 2020).

Stiffness is defined as a biomechanical property that represents the resistance to deformation which is directly related to the clinical measurement of muscle tone felt during palpation (Nordin andFrankel., 2012). Both stress relaxation time and creep are viscoelastic properties of the myofascia. Stress relaxation time means the time for a muscle to return to its original shape from deformation after the removal of the causative external load. However, Creep is defined as the gradual lengthening of a muscle and connective tissues over time when put under persistent tensile stress (Myoton., 2013).

In this study we will investigate if the midline spinal anaesthesia for cesarean delivery will be associated with decreased L4-5 interspinous pain pressure threshold - lower PPT yields higher pain - after cesarean delivery or not, and we will compare these findings of L4-5 interspinous pain pressure threshold and the biomechanical properties (stiffness, relaxation time and creeping) of L4-5 supraspinous ligament. Due to the lack of previous objective studies and to fill the gap in this point, this study will be considered the first conducted study to answer our research question.

The null hypothesis indicates that spinal anaesthesia for cesarean delivery has neither a relative risk for decreased L4-5 interspinous pain pressure threshold nor L4-5 supraspinous ligament biomechanical changes.

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• Egypt
  • Qena
    • Qinā, Qena, Egypt, 83523
      • Faculty of physical therapy, South Valley University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

1. All women in the epidural and spinal anesthetic groups gave birth through a cesarean delivery.
2. All women either primiparous or multiparous have not had anesthesia (epidural, spinal ) for at least one year prior to the last obstetric anesthesia.
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 anesthetic technique was the paramedian approach of spinal anesthesia.
3. Women with urinary tract infections and diastasis recti.
4. Women who were below 18 years old or above 35 years old.
5. Women who had (BMI) above 30 or waist to hip ratio above 1.
6. Women who did not continue all assessment procedures.
7. Women who had any non-myofascial low back dysfunctions as women who were diagnosed with lumbar disc prolapse or spondylolisthesis.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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; Other Names: 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); 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; Other Names: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
L4-5 supraspinous ligament Stiffness in Newton/meter	The MyotonPRO device measures Stiffness which is defined as a biomechanical property that represent the resistance to deformation which is directly related to the clinical measurement of muscle tone felt during palpation	Assessment will be done 6-12 weeks after the use of anaesthesia during Cesarean section
L4-5 supraspinous ligament Stress Relaxation Time in milliseconds	The MyotonPRO device measures Stress relaxation time which means the time for a muscle to return to its original shape from deformation after removal of the causative external load	Assessment will be done 6-12 weeks after the use of anaesthesia during Cesarean section
L4-5 supraspinous ligament Creep in Deborah number	The MyotonPRO device measures Creep that is defined as the gradual lengthening of a muscle and connective tissues over time when put under a persistent tensile stress	Assessment will be done 6-12 weeks after the use of anaesthesia during Cesarean section

Collaborators and Investigators

• Sponsor: South Valley University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 28, 2021
• Primary Completion (ACTUAL): January 29, 2022
• Study Completion (ACTUAL): April 15, 2022

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (ACTUAL): May 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Algometry VS Myoton PRO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No