Chronic Non-specific Low Back PainNCT06071364
Morphological Changes in Back Muscles With Low Back Pain Patients
An observational study of Chronic Non-specific Low Back Pain, run by omnia Yasser Mohamed Talat Harb at 1 site in Egypt.
Trial summary
The purpose of this study is to assess the morphological changes in the lumbar multifidus, Erector spinae and Quadratus lumborum muscles and to investigate whether they are correlated with trunk extensor muscle strength in CNSLBP subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Non-specific Low Back Pain
- What is being tested?
- Ultrasonography imaging and Hand-held dynamometer (HHD)
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to Jan 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Outpatient clinic of Mallawi Hospital
Who may be able to join
- Subjects of both genders with CNSLBP (pain> 3 months)
- The subject's age ranged between 18 and 45.
- waist-to-height ratio (WHtR) < 0.5 or = 0.5
Who cannot join
- Untreated neurological and/or mental illness
- History of trauma in the last 6 months.
- Sacroiliac joint pathologies.
- Spinal fracture or dislocation.
- Spinal instability (e.g., spondylolisthesis or retrolisthesis)
- Sensitivity to ultrasound gel diagnosed by a medical doctor.
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- Serious musculoskeletal problems or other pathologies.
- Previous surgery in lower limb(s)
- Females during Pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
Omnia Yasser, master, 01064840245, monyyasser36@gmail.com
Nesreen Fawzy, lecturer, 01127283925, dr_nesreenfawzy@cu.edu.eg
About this study
Official title: Morphological Changes in Selected Back Muscles and Their Association With Back Extensors Strength in Subjects With Chronic Non-Specific Low Back Pain
The purpose of this study is to assess the morphological changes in the lumbar multifidus, Erector spinae and Quadratus lumborum muscles and to investigate whether they are correlated with trunk extensor muscle strength in CNSLBP subjects.
and to compare between these morphological changes during rest and contraction and to compare these results with control group.
Twenty-nine subjects with CNSLBP and 29 age-matched healthy controls will be assessed by ultrasonography to detect the morphological changes of these muscles during rest and contraction ,and assessed strength of back extensors by hand-held dynamometer, and assessed functional disability by Arabic version of Oswestry disability index . They will be asked to sign the informed consent form.
Read the detailed description
Low back pain (LBP) is one of the most common musculoskeletal disorders leading to inactivity, postural disorders, and muscle problems and can result in disability, reduced quality of life, and workforce loss.
Low back pain is commonly classified as non-specific (90%) or specific (10%) according to reported cause and as acute (<6 weeks), subacute (6-12 weeks) or chronic (more than12 weeks) according to duration of symptoms.
Many factors have been reported to play a role in the etiology of Chronic non-specific Low back pain (CNSLBP) including occupational factors, personal factors, and behavioral risk factors. In addition, recent studies associate low back pain with physical factors such as lumbar spinal stiffness, muscle shortness, and decreased endurance and muscle strength.
Many studies have mainly focused on the morphological aspects of paraspinal muscles including lumbar multifidus , Erector spinae and Quadratus lumborum muscles, which play an essential role in patients with CNSLBP in terms of functional disability and the planning of rehabilitation modalities.
Twenty-nine subjects with CNSLBP and 29 age-matched healthy controls will be recruited through direct referral. They will be asked to sign the informed consent form.
To authors knowledge no previous research had investigated the correlation between morphological changes and strength of back muscles in subjects with CNSLBP
The finding of this proposed work may help researchers interested in CNSLBP's etiology and natural course which can be considered a topic that are still poorly understood. To reduce the occurrence and severity of CNSLBP, it is essential to help understand its cause and determine whether there are any risk factors that may be changed.
The finding of this proposed work may benefit patients diagnosed with CNSLBP. If the diagnosis of back pain, function, and muscle strength in those patients become more clear , not only this may make them return to work early but may also improve psychological status.
- Conditions
- Chronic Non-specific Low Back Pain
- Being tested
- Ultrasonography imaging and Hand-held dynamometer (HHD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography imaging and Hand-held dynamometer (HHD)Diagnostic test
Ultrasound imaging system will be used to evaluate the thickness, cross -sectional area and fat infiltration of lumbar extensors lumbar multifidus , erector spinae and quadratus lumborum muscles.
The hand-held dynamometer assessing isometric lumbar muscles strength
| Study group | Role | What they receive |
|---|---|---|
| chronic nonspecific low back pain patients | Twenty-nine participants experienced chronic non-specific low back pain for over three months without any referred pain in their legs. Receives: Diagnostic Test: Ultrasonography imaging and Hand-held dynamometer (HHD) | |
| Asymptomatic subjects | Twenty-nine subjects without symptoms of low back pain Receives: Diagnostic Test: Ultrasonography imaging and Hand-held dynamometer (HHD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional disability
Functional disability will be measured by Arabic version of Oswestry Disability Index (ODI). The ODI is a 10-item self-assessing questionnaire, each item contains 6 levels of answers that can be scored from 0 (minimum degree of difficulty in that activity) to 5 (maximum degree of difficulty). These items are pain, personal care, lifting and moving objects, walking, sitting, standing, sleep disorders caused by the low back pain, sex life, social life, and traveling The Arabic version of ODI has been established as a valid measure, and demonstrated excellent intra-observer reliability.
Measured: from 5 to 10 minutes
Back muscle strength
will be measured by Hand-held dynamometer (HHD): assessing isometric lumbar muscles strength. In a clinical setting, it is viewed as easy to use, portable and cost-effective for the precise measurement of lumbar muscles strength. Intra-rater and inter-rater reliability of hand-held dynamometer for assessing isometric lumbar muscle strength in asymptomatic healthy population showed an excellent intra-rater (ICC 2, k = 0.95 to 0.97) and inter-rater (ICC 2, k = 0.94 to 0.95) .
Measured: from 5 to 7 minutes
Muscle Thickness
evaluate the thickness of lumbar extensors lumbar multifidus, erector spinae and quadratus lumborum muscles and will be assessed by an experienced and qualified radiologist using US unit at rest and contraction on both right and left sides.
Measured: about 15 minutes
Muscle Cross Sectional Area
evaluate cross -sectional area of lumbar extensors lumbar multifidus, erector spinae and quadratus lumborum muscles and will be assessed by an experienced and qualified radiologist using US unit during rest and contraction on both right and left sides.
Measured: about 15 minutes
Muscle Fat infiltration
evaluate Fat infiltration of lumbar extensors lumbar multifidus, erector spinae and quadratus lumborum muscles and will be assessed by an experienced and qualified radiologist using US unit during rest and contraction on both right and left sides.
Measured: about 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Jul 2023
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-specific Low Back PainStudies 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
- Cross-sectional
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- omnia Yasser Mohamed Talat Harb
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, omnia Yasser Mohamed Talat Harb, Cairo University
- Investigators
- omnia yasser, master, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071364
- Sponsor's protocol ID
- P.T.REC/012/004639
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological Changes in Selected Back Muscles and Their Association With Back Extensors Strength in Subjects With Chronic Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06071364
- Acronym / sponsor ID
- P.T.REC/012/004639
- Conditions
- Chronic Non-specific Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- omnia Yasser Mohamed Talat HarbUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 6 Oct 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 purpose of this study is to assess the morphological changes in the lumbar multifidus, Erector spinae and Quadratus lumborum muscles and to investigate whether they are correlated with trunk extensor muscle strength in CNSLBP subjects.
and to compare between these morphological changes during rest and contraction and to compare these results with control group.
Twenty-nine subjects with CNSLBP and 29 age-matched healthy controls will be assessed by ultrasonography to detect the morphological changes of these muscles during rest and contraction ,and assessed strength of back extensors by hand-held dynamometer, and assessed functional disability by Arabic version of Oswestry disability index . They will be asked to sign the informed consent form.
Detailed description
Low back pain (LBP) is one of the most common musculoskeletal disorders leading to inactivity, postural disorders, and muscle problems and can result in disability, reduced quality of life, and workforce loss.
Low back pain is commonly classified as non-specific (90%) or specific (10%) according to reported cause and as acute (<6 weeks), subacute (6-12 weeks) or chronic (more than12 weeks) according to duration of symptoms.
Many factors have been reported to play a role in the etiology of Chronic non-specific Low back pain (CNSLBP) including occupational factors, personal factors, and behavioral risk factors. In addition, recent studies associate low back pain with physical factors such as lumbar spinal stiffness, muscle shortness, and decreased endurance and muscle strength.
Many studies have mainly focused on the morphological aspects of paraspinal muscles including lumbar multifidus , Erector spinae and Quadratus lumborum muscles, which play an essential role in patients with CNSLBP in terms of functional disability and the planning of rehabilitation modalities.
Twenty-nine subjects with CNSLBP and 29 age-matched healthy controls will be recruited through direct referral. They will be asked to sign the informed consent form.
To authors knowledge no previous research had investigated the correlation between morphological changes and strength of back muscles in subjects with CNSLBP
The finding of this proposed work may help researchers interested in CNSLBP's etiology and natural course which can be considered a topic that are still poorly understood. To reduce the occurrence and severity of CNSLBP, it is essential to help understand its cause and determine whether there are any risk factors that may be changed.
The finding of this proposed work may benefit patients diagnosed with CNSLBP. If the diagnosis of back pain, function, and muscle strength in those patients become more clear , not only this may make them return to work early but may also improve psychological status.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic nonspecific low back pain patients | – | Diagnostic Test: Ultrasonography imaging and Hand-held dynamometer (HHD)Twenty-nine participants experienced chronic non-specific low back pain for over three months without any referred pain in their legs. |
| Asymptomatic subjects | – | Diagnostic Test: Ultrasonography imaging and Hand-held dynamometer (HHD)Twenty-nine subjects without symptoms of low back pain |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Outpatient clinic of Mallawi Hospital
Key inclusion criteria (3 listed)
- Subjects of both genders with CNSLBP (pain> 3 months)
- The subject's age ranged between 18 and 45.
- waist-to-height ratio (WHtR) < 0.5 or = 0.5
Key exclusion criteria (9 listed)
- Untreated neurological and/or mental illness
- History of trauma in the last 6 months.
- Sacroiliac joint pathologies.
- Spinal fracture or dislocation.
- Spinal instability (e.g., spondylolisthesis or retrolisthesis)
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 |
|---|---|---|
| Ultrasonography imaging and Hand-held dynamometer (HHD)Ultrasound imaging system will be used to evaluate the thickness, cross -sectional area and fat infiltration of lumbar extensors lumbar multifidus , erector spinae and quadratus lumborum muscles. The hand-held dynamometer assessing isometric lumbar muscles strength | Diagnostic test | Asymptomatic subjects, chronic nonspecific low back pain patients |
Primary outcome
Functional disability
Time frame: from 5 to 10 minutes
Functional disability will be measured by Arabic version of Oswestry Disability Index (ODI). The ODI is a 10-item self-assessing questionnaire, each item contains 6 levels of answers that can be scored from 0 (minimum degree of difficulty in that activity) to 5 (maximum degree of difficulty). These items are pain, personal care, lifting and moving objects, walking, sitting, standing, sleep disorders caused by the low back pain, sex life, social life, and traveling The Arabic version of ODI has been established as a valid measure, and demonstrated excellent intra-observer reliability.
Back muscle strength
Time frame: from 5 to 7 minutes
will be measured by Hand-held dynamometer (HHD): assessing isometric lumbar muscles strength. In a clinical setting, it is viewed as easy to use, portable and cost-effective for the precise measurement of lumbar muscles strength. Intra-rater and inter-rater reliability of hand-held dynamometer for assessing isometric lumbar muscle strength in asymptomatic healthy population showed an excellent intra-rater (ICC 2, k = 0.95 to 0.97) and inter-rater (ICC 2, k = 0.94 to 0.95) .
Muscle Thickness
Time frame: about 15 minutes
evaluate the thickness of lumbar extensors lumbar multifidus, erector spinae and quadratus lumborum muscles and will be assessed by an experienced and qualified radiologist using US unit at rest and contraction on both right and left sides.
Muscle Cross Sectional Area
Time frame: about 15 minutes
evaluate cross -sectional area of lumbar extensors lumbar multifidus, erector spinae and quadratus lumborum muscles and will be assessed by an experienced and qualified radiologist using US unit during rest and contraction on both right and left sides.
Muscle Fat infiltration
Time frame: about 15 minutes
evaluate Fat infiltration of lumbar extensors lumbar multifidus, erector spinae and quadratus lumborum muscles and will be assessed by an experienced and qualified radiologist using US unit during rest and contraction on both right and left sides.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Individual participant dataSharing planned: No. undecided
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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.
omnia yasser, master principal investigator
Cairo University
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 Chronic Non-specific Low Back Pain, run by omnia Yasser Mohamed Talat Harb 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 9 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: status not confirmed, as of the sponsor's last update on 11 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omnia Yasser, Master (01064840245, monyyasser36@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional disability (time frame: from 5 to 10 minutes). The study lists 5 primary outcomes in all. 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 11 Oct 2023.