Low Back Pain, MechanicalNCT06255587
Relationship Between the Sagittal Lumbopelvic Alignment and Balance Control in Adolescents With Mechanical Low Back Pain
An observational study of Low Back Pain, Mechanical, run by Benha University.
Trial summary
To examine the relationships between lumbopelvic sagittal alignment parameters (lumbar lordosis, sacral slope, pelvic tilt, and pelvic incidence) and balance control in adolescents with mechanical low back pain. Read more about this study
- Who is it for?
- Ages 15 to 18 years
- Conditions the study is for
- Low Back Pain, Mechanical
- What is being tested?
- Screening
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Apr 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 15 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents with low back pain
Who may be able to join
- age between 15 and 18 years, either sex, and symptoms lasting longer than three months, which imply chronicity
Who cannot join
- Spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for LBP
About this study
To examine the relationships between lumbopelvic sagittal alignment parameters (lumbar lordosis, sacral slope, pelvic tilt, and pelvic incidence) and balance control in adolescents with mechanical low back pain.
Read the detailed description
To examine the relationships between lumbopelvic sagittal alignment parameters (lumbar lordosis, sacral slope, pelvic tilt, and pelvic incidence) and balance control in adolescents with mechanical low back pain.Patients will be recruited from the secondary schools in Benha city be general invitations, and the study will be conducted at outpatient clinic of faculty of physical therapy, Benha University
- Conditions
- Low Back Pain, Mechanical
- Being tested
- Screening
- 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.
ScreeningOther
cross sectional
What is being measured
The primary outcome is the main question the study is designed to answer.
level of back pain
Visual Analogue scale
Measured: 10 minutes
standardized lateral views radiographs in a neutral standing position for the lumbopelvic region
Lumbar lordosis, sacral slope, pelvic tilt, and pelvic incidence
Measured: 15 minutes
Balance control
Biodex Balance system
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion15 Mar 2024 (estimated)
- Study completion1 Apr 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 Pain, MechanicalStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Helmy Koura, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255587
- Sponsor's protocol ID
- PT.BU.EC.5
- Status last verified
- Feb 2024
- First submitted
- 5 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Sagittal Lumbopelvic Alignment and Balance Control in Adolescents With Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT06255587
- Acronym / sponsor ID
- PT.BU.EC.5
- Conditions
- Low Back Pain, Mechanical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 13 Feb 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.
To examine the relationships between lumbopelvic sagittal alignment parameters (lumbar lordosis, sacral slope, pelvic tilt, and pelvic incidence) and balance control in adolescents with mechanical low back pain.
Detailed description
To examine the relationships between lumbopelvic sagittal alignment parameters (lumbar lordosis, sacral slope, pelvic tilt, and pelvic incidence) and balance control in adolescents with mechanical low back pain.Patients will be recruited from the secondary schools in Benha city be general invitations, and the study will be conducted at outpatient clinic of faculty of physical therapy, Benha University
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with low back pain
Key inclusion criteria (1 listed)
- age between 15 and 18 years, either sex, and symptoms lasting longer than three months, which imply chronicity
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| Screeningcross sectional | Other | – |
Primary outcome
level of back pain
Time frame: 10 minutes
Visual Analogue scale
standardized lateral views radiographs in a neutral standing position for the lumbopelvic region
Time frame: 15 minutes
Lumbar lordosis, sacral slope, pelvic tilt, and pelvic incidence
Balance control
Time frame: 20 minutes
Biodex Balance system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, Mechanical, run by Benha University.
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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
level of back pain (time frame: 10 minutes). The study lists 3 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 13 Feb 2024.