Low Back Biomechanical DysfunctionsNCT05367323
Pain Pressure Threshold Values Versus the Biomechanical-Viscoelastic Findings of L4-5 Supraspinous Ligament in Women Who Underwent Cesarean Delivery With Spinal Anaesthesia
An observational study of Low Back Biomechanical Dysfunctions, run by South Valley University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Low Back Biomechanical Dysfunctions
- What is being tested?
- Pressure algometry (Baseline 2.2-Pound Dolorimeter) and Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jun 2021to 15 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Adult
Study population: Retrospective Cohort Study in which 44 women participated in this study. They were selected from South Valley University Teaching Hospitals.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of physical therapy, South Valley University
Qina, Qena Governorate, 83523
About this study
Official title: 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).
Read the 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.
- Conditions
- Low Back Biomechanical Dysfunctions
- Being tested
- Pressure algometry (Baseline 2.2-Pound Dolorimeter) and Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure algometry (Baseline 2.2-Pound Dolorimeter) and Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)Device
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Group A | 22 women who underwent cesarean delivery using spinal anesthesia Receives: 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) Receives: Device: Pressure algometry (Baseline 2.2-Pound Dolorimeter) and Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: 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
Measured: Assessment will be done 6-12 weeks after the use of anaesthesia during Cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start28 Jun 2021
- Primary completion29 Jan 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Biomechanical DysfunctionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal Abouelyazeed Ali, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367323
- Sponsor's protocol ID
- Algometry VS Myoton PRO
- Status last verified
- Oct 2022
- First submitted
- 27 Apr 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Pain Pressure Threshold Consistent With the Biomechanical-Viscoelastic Changes for L4-5 Supraspinous Ligament in Women Undergoing Midline Spinal Anaesthesia for Cesarean Delivery
- ClinicalTrials.gov ID
- NCT05367323
- Acronym / sponsor ID
- Algometry VS Myoton PRO
- Conditions
- Low Back Biomechanical Dysfunctions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 29 Jan 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: Pressure algometry (Baseline 2.2-Pound Dolorimeter) and Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)22 women who underwent cesarean delivery using spinal anesthesia |
| Group B | – | Device: Pressure algometry (Baseline 2.2-Pound Dolorimeter) and Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)22 women who were in the control group (they never experience pregnancy, or anaesthesia) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Retrospective Cohort Study in which 44 women participated in this study. They were selected from South Valley University Teaching Hospitals.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure algometry (Baseline 2.2-Pound Dolorimeter) and Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)Also: 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 | Device | Group A, Group B |
Primary outcome
L4-5 Supraspinous Ligament Pain pressure threshold in Pounds
Time frame: Assessment will be done 6-12 weeks after the use of anaesthesia during Cesarean section
The PPT is a quantitative sensory value for tissue sensitivity that is defined as the smallest amount of pressure that causes pain
3 secondary outcomes
L4-5 supraspinous ligament Stiffness in Newton/meter
Time frame: Assessment will be done 6-12 weeks after the use of anaesthesia during Cesarean section
L4-5 supraspinous ligament Stress Relaxation Time in milliseconds
Time frame: Assessment will be done 6-12 weeks after the use of anaesthesia during Cesarean section
L4-5 supraspinous ligament Creep in Deborah number
Time frame: Assessment will be done 6-12 weeks after the use of anaesthesia during Cesarean section
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
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Low Back Biomechanical Dysfunctions, Post Partum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Biomechanical Dysfunctions, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
L4-5 Supraspinous Ligament Pain pressure threshold in Pounds (time frame: Assessment will be done 6-12 weeks after the use of anaesthesia during Cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.