Low Back Pain, MechanicalNCT06031649
Lumbar Paraspinal Muscular Properties After Cesarean Delivery
An observational study of Low Back Pain, Mechanical, run by South Valley University at 1 site in Egypt.
Trial summary
The biomechanical characteristics of lumbar paraspinal muscles may give us insight into different lower back dysfunctions in postpartum mothers after cesarean section. Read more about this study
- Who is it for?
- Ages 20 to 34 years, women only
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- MyotonPRO device
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jun 2021to 15 Feb 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 20 to 34 years
- Women only
- No healthy volunteers
- Adult
Study population: 60 females participated in this research, aged between 20 and 34 years old. They were free of specific lower back disorders. They were recruited from the outpatient clinics of South Valley Hospitals
Who may be able to join
- Women who experienced cesarean section at least for one time
- Women Who are free of specific lower back disorders
- Women who are below 34 years old and above 20 years old
Who cannot join
- Women who experienced normal vaginal birth
- Women who complain of a specific lower back disorder
- Women who are above 34 years old or below 20 years old
- Women who have a body mass index above 30 Kg/m2
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
The biomechanical characteristics of lumbar paraspinal muscles may give us insight into different lower back dysfunctions in postpartum mothers after cesarean section.
Read the detailed description
Stiffness and elasticity are two mechanical characteristics of the muscles, whereas relaxation time and creeping are two viscoelastic characteristics.
Different studies investigated the mechanical properties of lumbar paraspinal muscles in numerous musculoskeletal conditions, however, no previous studies investigated these characteristics after cesarean section, which is associated with high prevalence of lower back pain when compared with normal delivery.
- Conditions
- Low Back Pain, Mechanical
- Being tested
- MyotonPRO device
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyotonPRO deviceDevice
Also called Myotonometry
It is a valid and reliable device for measuring the muscular mechanical properties
| Study group | Role | What they receive |
|---|---|---|
| Group A | 30 mother underwent cesarean section Receives: Device: MyotonPRO device | |
| Group B | 30 healthy females who were in the control group Receives: Device: MyotonPRO device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar Paraspinal Muscles Stiffness, measured by the MyotonPRO device in units of N/m.
muscular stiffness refers to muscle resistance against forces that deform it.
Measured: 6-12 weeks after cesarean section
Lumbar Paraspinal Muscles Elasticity, measured by the MyotonPRO device in a relative unit
Muscular Elasticity refers to the muscular ability to return to its original shape after the removal of tensional forces.
Measured: 6-12 weeks after cesarean section
Secondary outcomes (2)
Lumbar Paraspinal Muscles Stress Relaxation Time, measured by the MyotonPRO device in milliseconds
relaxation time is a viscoelastic characteristic of the muscles, it refers to the time taken to return to the original shape after the removal of the deformative forces.
Measured: 6-12 weeks after cesarean section
Lumbar Paraspinal Muscles Creep, measured by the MyotonPRO device in a relative unit
Muscular creep refers to the muscular ability to lengthen when constant stresses applied to it.
Measured: 6-12 weeks after cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start28 Jun 2021
- Primary completion29 Jan 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back Pain, MechanicalStudies 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
- 60 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
- NCT06031649
- Sponsor's protocol ID
- Lumbar Paraspinal Muscles
- Status last verified
- Jan 2025
- First submitted
- 25 Aug 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van 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 28005829Struzik 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 34721664Parikh S, Suchi J. Prevalence of low back pain and its impact on quality of life in post-partum women. International Journal of Scientific Research. 2016; 7:14342-8.
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Paraspinal Muscular Properties After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT06031649
- Acronym / sponsor ID
- Lumbar Paraspinal Muscles
- Conditions
- Low Back Pain, Mechanical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 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 Feb 2022 (actual)
- First posted
- 11 Sep 2023 (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.
The biomechanical characteristics of lumbar paraspinal muscles may give us insight into different lower back dysfunctions in postpartum mothers after cesarean section.
Detailed description
Stiffness and elasticity are two mechanical characteristics of the muscles, whereas relaxation time and creeping are two viscoelastic characteristics.
Different studies investigated the mechanical properties of lumbar paraspinal muscles in numerous musculoskeletal conditions, however, no previous studies investigated these characteristics after cesarean section, which is associated with high prevalence of lower back pain when compared with normal delivery.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: MyotonPRO device30 mother underwent cesarean section |
| Group B | – | Device: MyotonPRO device30 healthy females who were in the control group |
Who may qualify
- Ages
- 20 to 34 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 60 females participated in this research, aged between 20 and 34 years old. They were free of specific lower back disorders. They were recruited from the outpatient clinics of South Valley Hospitals
Key inclusion criteria (3 listed)
- Women who experienced cesarean section at least for one time
- Women Who are free of specific lower back disorders
- Women who are below 34 years old and above 20 years old
Key exclusion criteria (4 listed)
- Women who experienced normal vaginal birth
- Women who complain of a specific lower back disorder
- Women who are above 34 years old or below 20 years old
- Women who have a body mass index above 30 Kg/m2
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 |
|---|---|---|
| MyotonPRO deviceAlso: MyotonometryIt is a valid and reliable device for measuring the muscular mechanical properties | Device | Group A, Group B |
Primary outcome
Lumbar Paraspinal Muscles Stiffness, measured by the MyotonPRO device in units of N/m.
Time frame: 6-12 weeks after cesarean section
muscular stiffness refers to muscle resistance against forces that deform it.
Lumbar Paraspinal Muscles Elasticity, measured by the MyotonPRO device in a relative unit
Time frame: 6-12 weeks after cesarean section
Muscular Elasticity refers to the muscular ability to return to its original shape after the removal of tensional forces.
2 secondary outcomes
Lumbar Paraspinal Muscles Stress Relaxation Time, measured by the MyotonPRO device in milliseconds
Time frame: 6-12 weeks after cesarean section
Lumbar Paraspinal Muscles Creep, measured by the MyotonPRO device in a relative unit
Time frame: 6-12 weeks after 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 7 Feb 2025.
- 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.
- 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.
- BackgroundParikh S, Suchi J. Prevalence of low back pain and its impact on quality of life in post-partum women. International Journal of Scientific Research. 2016; 7:14342-8.
- 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 Low Back Pain, Mechanical, 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 3 inclusion and 4 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 7 Feb 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 Paraspinal Muscles Stiffness, measured by the MyotonPRO device in units of N/m. (time frame: 6-12 weeks after cesarean section). 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 NCT06031649, which also lists 3 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 7 Feb 2025.