Low Back PainNCT06186674
Prediction of Back Disability in Adults With Low Back Pain
An observational study of Low Back Pain, run by Benha University at 1 site in Egypt.
Trial summary
Low back pain (LBP) is one of the most enormous and challenging disorders. LBP represents a leading cause of disability worldwide. A number of variables (clinical, functional and mechanical) may predispose to back disability. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- sorensen test for back endurance, 6 minute walk test and c7-s1 SVA
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2023to 15 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 20 to 40 years
- All sexes
- Adult
Study population: 100 subjects will be recruited from the university A local advertisement sent via e-mail to the university's postgraduate students and administrative staff
Who may be able to join
- age between 20 and 40 years, either sex, and symptoms lasting longer than three months, which imply chronicity
Who cannot join
- Pregnancy, Spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for LBP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Back Disability Using Clinical, Functional, and Bio-mechanical Variables in Adults With Low Back Pain
Low back pain (LBP) is one of the most enormous and challenging disorders. LBP represents a leading cause of disability worldwide. A number of variables (clinical, functional and mechanical) may predispose to back disability. Clinical variables such as pain may affect the patient ability to move and also may result in muscle spasm that led to more pain and movement restriction. Further, functional capabilities may affect the patient and when reduced may lead to disability. Moreover, biomechanical factors such as abnormal posture creates abnormal stress and strain in many spinal structures which are considered predisposing factors for pain and disability.
There is a gab of evidence to examine the relationships between those variables and to predict disability in patients with chronic nonspecific low back pain using various variables.
- Conditions
- Low Back Pain
- Being tested
- sorensen test for back endurance, 6 minute walk test, c7-s1 SVA
- Keywords
- posture
- 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.
sorensen test for back enduranceDiagnostic test
- Biering-Sorensen test will be utilized to gauge the trunk extensor muscles' isometric endurance. The patient will be lying on a treatment couch, prone. The top half of the body will be permitted to rest on a chair prior to the test starting. The patient will be told to elevate their upper trunks off of the chair at the start of the test. the examiner determined how long the individual could hold this position.
6 minute walk testDiagnostic test
It gauges how far a person can go while walking for a total of six minutes on a level, hard surface. Cones will be used to mark turns at the start and end of the 30-meter border and every three meters throughout the corridor or walkway that was utilized for the test. The patient's objective is to cover the most distance in six minutes at a reasonable pace.
It gauges how far a person can go while walking for a total of six minutes on a level, hard surface. Cones will be used to mark turns at the start and end of the 30-meter border and every three meters throughout the corridor or walkway that was utilized for the test. The patient's objective is to cover the most distance in six minutes at a reasonable pace.
c7-s1 SVADiagnostic test
Subjects will obtain standardized lateral views radiographs in a neutral standing position for the whole spine. The C7- S1 SVA will be measured as the distance from the plumb line dropped from the center of the C7 vertebral body to the most posterior edge of the upper sacral endplate surface.
| Study group | Role | What they receive |
|---|---|---|
| normal | normal persons Receives: Diagnostic Test: sorensen test for back endurance; Diagnostic Test: 6 minute walk test; Diagnostic Test: c7-s1 SVA | |
| low back pain | patients with low back pain Receives: Diagnostic Test: sorensen test for back endurance; Diagnostic Test: 6 minute walk test; Diagnostic Test: c7-s1 SVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
back disability using oswestry disability index
oswestry disability index has been designed to give us information as to how your back pain has affected your ability to manage everyday life. For each question, there is a possible 5 points; 0 for the first answer, 1 for the second answer, etc. Add up the total for the 10 questions and rate them on the scale at right.. 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled
Measured: 1 month
back pain intensity using visual analogue scale
visual analogue scale (VAS) is one of the pain rating scales used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
Measured: 1 month
Secondary outcomes (1)
back functional ability using back performance scale
Back performance scale (BPS) has been found to reflect important aspects of physical functioning. It consists of Sock Test, the Pick-up Test, the Roll-up Test, the Fingertip-to-Floor Test, and the Lift Test. For each test a score of 0 was considered a good performance with no signs of activity limitation, a score of 1 was considered a somewhat limited performance, a score of 2 was considered a rather distinct limitation of performance, and a score of 3 was considered a substantially limited performance, if performed at all. The BPS sum score is calculated by adding the individual scores of the 5 tests ranging from 0 to 15.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start12 Dec 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Mohamed Elabd, Benha University
- Investigators
- Aliaa M Elabd, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186674
- Sponsor's protocol ID
- PT.BU.EC.1
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: will be available up on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Back Disability Using Clinical, Functional, and Bio-mechanical Variables in Adults With Low Back Pain
- ClinicalTrials.gov ID
- NCT06186674
- Acronym / sponsor ID
- PT.BU.EC.1
- Conditions
- Low Back Pain
- Keywords
- posture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 2 Jan 2024 (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.
Low back pain (LBP) is one of the most enormous and challenging disorders. LBP represents a leading cause of disability worldwide. A number of variables (clinical, functional and mechanical) may predispose to back disability. Clinical variables such as pain may affect the patient ability to move and also may result in muscle spasm that led to more pain and movement restriction. Further, functional capabilities may affect the patient and when reduced may lead to disability. Moreover, biomechanical factors such as abnormal posture creates abnormal stress and strain in many spinal structures which are considered predisposing factors for pain and disability.
There is a gab of evidence to examine the relationships between those variables and to predict disability in patients with chronic nonspecific low back pain using various variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal | – | Diagnostic Test: sorensen test for back endurance, Diagnostic Test: 6 minute walk test, Diagnostic Test: c7-s1 SVAnormal persons |
| low back pain | – | Diagnostic Test: sorensen test for back endurance, Diagnostic Test: 6 minute walk test, Diagnostic Test: c7-s1 SVApatients with low back pain |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- 100 subjects will be recruited from the university A local advertisement sent via e-mail to the university's postgraduate students and administrative staff
Key inclusion criteria (1 listed)
- age between 20 and 40 years, either sex, and symptoms lasting longer than three months, which imply chronicity
Key exclusion criteria (1 listed)
- Pregnancy, Spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for LBP
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 |
|---|---|---|
| sorensen test for back endurance• Biering-Sorensen test will be utilized to gauge the trunk extensor muscles' isometric endurance. The patient will be lying on a treatment couch, prone. The top half of the body will be permitted to rest on a chair prior to the test starting. The patient will be told to elevate their upper trunks off of the chair at the start of the test. the examiner determined how long the individual could hold this position. | Diagnostic test | low back pain, normal |
| 6 minute walk testIt gauges how far a person can go while walking for a total of six minutes on a level, hard surface. Cones will be used to mark turns at the start and end of the 30-meter border and every three meters throughout the corridor or walkway that was utilized for the test. The patient's objective is to cover the most distance in six minutes at a reasonable pace. It gauges how far a person can go while walking for a total of six minutes on a level, hard surface. Cones will be used to mark turns at the start and end of the 30-meter border and every three meters throughout the corridor or walkway that was utilized for the test. The patient's objective is to cover the most distance in six minutes at a reasonable pace. | Diagnostic test | low back pain, normal |
| c7-s1 SVASubjects will obtain standardized lateral views radiographs in a neutral standing position for the whole spine. The C7- S1 SVA will be measured as the distance from the plumb line dropped from the center of the C7 vertebral body to the most posterior edge of the upper sacral endplate surface. | Diagnostic test | low back pain, normal |
Primary outcome
back disability using oswestry disability index
Time frame: 1 month
oswestry disability index has been designed to give us information as to how your back pain has affected your ability to manage everyday life. For each question, there is a possible 5 points; 0 for the first answer, 1 for the second answer, etc. Add up the total for the 10 questions and rate them on the scale at right.. 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled
back pain intensity using visual analogue scale
Time frame: 1 month
visual analogue scale (VAS) is one of the pain rating scales used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
1 secondary outcome
back functional ability using back performance scale
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Individual participant dataSharing planned: Yes. will be available up on reasonable request
Related trials for Low Back Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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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.
Aliaa M Elabd principal investigator
Benha 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 Low Back Pain, run by Benha 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 1 inclusion and 1 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 2 Jan 2024. 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?
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?
back disability using oswestry disability index (time frame: 1 month). 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?
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 Jan 2024.