Lumbar Paravertebral MusclesNCT05503758
Biomechanical Properties of the Lumbar Paravertebral Muscles
An observational study of Lumbar Paravertebral Muscles, run by South Valley University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Lumbar Paravertebral Muscles
- What is being tested?
- Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jun 2021to 29 Jan 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: Sixty-three women participated in this study and were recruited from South Valley University Teaching Hospitals, in Qena governorate, Egypt.
Who may be able to join
- 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.
Who cannot join
- 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.
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: Quantification of Different Lumbar Paravertebral Muscles Properties in Women Who Experienced Cesarean Delivery Under Different Types of Anaesthesia
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.
Read the 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.
- Conditions
- Lumbar Paravertebral Muscles
- Being tested
- 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.
Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)Device
Also called Myotonometry
The MyotoPRO device is a portable objective device for measuring the contractile (tone), and biomechanical (stiffness) properties of lumbar paravertebral muscles (LPVMs).
| Study group | Role | What they receive |
|---|---|---|
| Group A | 9 participants have exposed to midline epidural anaesthesia for cesarean delivery. Receives: Device: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia) | |
| Group B | 22 participants have exposed to midline spinal anaesthesia for cesarean delivery. Receives: Device: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia) | |
| Group C | 10 participants underwent general anesthesia for cesarean delivery. Receives: Device: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia) | |
| Group D | 22 participants were in the control group (no previous pregnancy or anaesthesia). Receives: Device: 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.
Lumbar paravertebral muscle frequency (tone)
Tone is a contractile property of a muscle which describes the resting muscle's resistance to passive and active stretch forces
Measured: Assessment will be done 6-12 weeks after the use of anaesthesia for Cesarean section by the MyotonPRO device
Lumbar paravertebral muscle stiffness
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
Measured: Assessment will be done 6-12 weeks after the use of anaesthesia for Cesarean section by the MyotonPRO device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start28 Jun 2021
- Primary completion29 Jan 2022
- Study completion29 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Lumbar Paravertebral MusclesStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 63 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
- NCT05503758
- Sponsor's protocol ID
- Lumbar Paravertebral muscles
- Status last verified
- Apr 2023
- First submitted
- 13 Aug 2022
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iddrisu M, Khan ZH. Anesthesia for cesarean delivery: general or regional anesthesia-a systematic review. Ain-Shams Journal of Anesthesiology. 2021 Dec;13(1):1-7.
Mhyre JM, Sultan P. General Anesthesia for Cesarean Delivery: Occasionally Essential but Best Avoided. Anesthesiology. 2019 Jun;130(6):864-866. doi: 10.1097/ALN.0000000000002708. No abstract available.
PubMed 30985305Lenhardt R. Body temperature regulation and anesthesia. Handb Clin Neurol. 2018;157:635-644. doi: 10.1016/B978-0-444-64074-1.00037-9.
PubMed 30459029Struzik A, Karamanidis K, Lorimer A, Keogh JWL, Gajewski J. Application of Leg, Vertical, and Joint Stiffness in Running Performance: A Literature Overview. Appl Bionics Biomech. 2021 Oct 21;2021:9914278. doi: 10.1155/2021/9914278. eCollection 2021.
PubMed 34721664Van Deun B, Hobbelen JSM, Cagnie B, Van Eetvelde B, Van Den Noortgate N, Cambier D. Reproducible Measurements of Muscle Characteristics Using the MyotonPRO Device: Comparison Between Individuals With and Without Paratonia. J Geriatr Phys Ther. 2018 Oct/Dec;41(4):194-203. doi: 10.1519/JPT.0000000000000119.
PubMed 28005829Sung, S., and Mahdy, H. (2021):
Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827.
PubMed 31151377Hamilton RI, Garden CLP, Brown SJ. Immediate effect of a spinal mobilisation intervention on muscle stiffness, tone and elasticity in subjects with lower back pain - A randomized cross-over trial. J Bodyw Mov Ther. 2022 Jan;29:60-67. doi: 10.1016/j.jbmt.2021.09.032. Epub 2021 Oct 9.
PubMed 35248290Lo WLA, Yu Q, Mao Y, Li W, Hu C, Li L. Lumbar muscles biomechanical characteristics in young people with chronic spinal pain. BMC Musculoskelet Disord. 2019 Nov 23;20(1):559. doi: 10.1186/s12891-019-2935-z.
PubMed 31759390
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Different Lumbar Paravertebral Muscles Properties in Women Who Experienced Cesarean Delivery Under Different Types of Anaesthesia
- ClinicalTrials.gov ID
- NCT05503758
- Acronym / sponsor ID
- Lumbar Paravertebral muscles
- Conditions
- Lumbar Paravertebral Muscles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 29 Jan 2022 (actual)
- Study completion
- 29 Jan 2022 (actual)
- First posted
- 17 Aug 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 (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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)9 participants have exposed to midline epidural anaesthesia for cesarean delivery. |
| Group B | – | Device: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)22 participants have exposed to midline spinal anaesthesia for cesarean delivery. |
| Group C | – | Device: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)10 participants underwent general anesthesia for cesarean delivery. |
| Group D | – | Device: Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)22 participants were in the control group (no previous pregnancy or anaesthesia). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Sixty-three women participated in this study and were recruited from South Valley University Teaching Hospitals, in Qena governorate, Egypt.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Myoton PRO device (MyotonPRO; Myoton AS, Tallinn, Estonia)Also: MyotonometryThe MyotoPRO device is a portable objective device for measuring the contractile (tone), and biomechanical (stiffness) properties of lumbar paravertebral muscles (LPVMs). | Device | Group A, Group B, Group C, Group D |
Primary outcome
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
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
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 2 Oct 2025.
- BackgroundIddrisu M, Khan ZH. Anesthesia for cesarean delivery: general or regional anesthesia-a systematic review. Ain-Shams Journal of Anesthesiology. 2021 Dec;13(1):1-7.
- Background: PubMed 30985305Mhyre JM, Sultan P. General Anesthesia for Cesarean Delivery: Occasionally Essential but Best Avoided. Anesthesiology. 2019 Jun;130(6):864-866. doi: 10.1097/ALN.0000000000002708. No abstract available.
- Background: PubMed 30459029Lenhardt R. Body temperature regulation and anesthesia. Handb Clin Neurol. 2018;157:635-644. doi: 10.1016/B978-0-444-64074-1.00037-9.
- Background: PubMed 34721664Struzik A, Karamanidis K, Lorimer A, Keogh JWL, Gajewski J. Application of Leg, Vertical, and Joint Stiffness in Running Performance: A Literature Overview. Appl Bionics Biomech. 2021 Oct 21;2021:9914278. doi: 10.1155/2021/9914278. eCollection 2021.
- Background: PubMed 28005829Van Deun B, Hobbelen JSM, Cagnie B, Van Eetvelde B, Van Den Noortgate N, Cambier D. Reproducible Measurements of Muscle Characteristics Using the MyotonPRO Device: Comparison Between Individuals With and Without Paratonia. J Geriatr Phys Ther. 2018 Oct/Dec;41(4):194-203. doi: 10.1519/JPT.0000000000000119.
- BackgroundSung, S., and Mahdy, H. (2021):
- Background: PubMed 31151377Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827.
- Background: PubMed 35248290Hamilton RI, Garden CLP, Brown SJ. Immediate effect of a spinal mobilisation intervention on muscle stiffness, tone and elasticity in subjects with lower back pain - A randomized cross-over trial. J Bodyw Mov Ther. 2022 Jan;29:60-67. doi: 10.1016/j.jbmt.2021.09.032. Epub 2021 Oct 9.
- Background: PubMed 31759390Lo WLA, Yu Q, Mao Y, Li W, Hu C, Li L. Lumbar muscles biomechanical characteristics in young people with chronic spinal pain. BMC Musculoskelet Disord. 2019 Nov 23;20(1):559. doi: 10.1186/s12891-019-2935-z.
- Individual participant dataSharing planned: No
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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 Lumbar Paravertebral Muscles, 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 2 Oct 2025. 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?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05503758, which also lists 9 linked publications.
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 2 Oct 2025; AzTrials last refreshed its copy on 8 Nov 2026.