Non-Specific Chronic Low-back PainNCT06716515
Influence of Gender Difference on Knee Proprioception in Non-Specific Low Back Pain Among Young Adults
An observational study of Non-Specific Chronic Low-back Pain, run by Cairo University.
Trial summary
the aim of the study is to investigate the impact of gender difference on knee proprioception among non specific low back pain young adults. Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Non-Specific Chronic Low-back Pain
- What is being tested?
- digital inclinometer
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 15 Feb 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 26 years
- All sexes
- Adult
Study population: Eighty-two Young Adults (include males and females), ranging in age from 18 to 26, will be included in the study. Individuals will be assigned into 2 groups. Group (A) 41 males with non specific low back pain (B) 41 females with non specific low back pain.
Who may be able to join
- Forty-one Patients from each gender participated in the study.
- Subject's age ranged from 18-26 years old, with Body Mass Index (BMI) less than 30Kg/m2
- The dominant knees of the subjects (defined as the leg used for kicking) are tested.
- Pain between three and eight using numerical pain rating scale NPRS, and Oswestry Disability Index score less than 20.
- All the subjects sign an informed consent form. 6. able to comprehend and follow the examiner's instructions.
Who cannot join
- limitation of active and passive knee joint motion.
- clinical signs of an impairment or abnormality in the knee (such as abnormal range of motion, muscle weakness, or malalignment).
- injury to the knee that required medical attention.
- current pain in the knee or previous surgery on the knee.
- not able to understand and follow the commands of the examiner.
About this study
the aim of the study is to investigate the impact of gender difference on knee proprioception among non specific low back pain young adults.
Read the detailed description
Low back pain (LBP) is one of the most common musculoskeletal disorders and the leading causes of disability and work absence globally. LBP notonly causes individual suffering, but also a heavy burden to the society. Despite this, up to 85% patients with LBP cannot be clearly diagnosed and are classified as non-specific LBP (NSLBP). Proprioception plays an important role in the planning of precise and coordinated movements, in maintaining balance and controlling body posture. It also exerts its influence on motor learning and re-education. Proprioception deficit has been identified in people with LBP and it has been suggested that these deficits might be associated with causes and mechanisms of LBP. Although the local investigation of proprioception is important, the proprioceptive deficits due to LBP may not be restricted only to the lumbar region. Anatomical and biomechanical associations between the knee and lower back segments imply that the knee might be adversely affected in patients with LBP.
there is a gap in the literature concerning sex differences in the knee joint proprioception. Although biomechanical and hormonal differences between males and females are suspected to be responsible for increasing this incidence.
- Conditions
- Non-Specific Chronic Low-back Pain
- Being tested
- digital inclinometer
- Keywords
- Gender Difference, Knee Proprioception, Chronic Non-Specific Low-back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital inclinometerDevice
Digital inclinometer to assess gender difference in knee repositioning error
| Study group | Role | What they receive |
|---|---|---|
| Males | Forty-one males will be evaluated using digital inclinometer in an open kinetic chain position. The JPS testing is conducted in the sitting position without feet floor contact, at a quiet place with closed eyes . Investigator will perform all the knee joint position sense assessments in the dominant extremity. The digital inclinometer is stabilized to the middle third of the subjects' leg (15 cm distal from the apex of the fibular head) with a strap. The starting position of the test is 90° flexion. The proprioception evaluation angle is defined at 30°. Participants are asked to extend their tested knee to the target angle of 30° from the initial position (90° knee flexion) then to return to their initial position after 5 seconds in this position ,The participant indicated by saying "YES" when they thought they reach the target, and the reposition accuracy will be measured as the joint position error (JPE) in degrees, as displayed on the digital inclinometer screen Receives: Device: digital inclinometer | |
| Females | Forty-one females will be assessed the same as group A , Then compare Results To investigate the impact of gender difference on knee proprioception among non specific low back pain young adults Receives: Device: digital inclinometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee proprioception
knee repositioning error is measured by digital inclinometer
Measured: up to 4 weeks
Secondary outcomes (1)
Functional disability
measured by Oswestry disability index (arabic version)
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Specific Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norhan Yousif Allam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716515
- Sponsor's protocol ID
- P.T.REC/012/005429
- Status last verified
- Dec 2024
- First submitted
- 29 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Gender Difference on Knee Proprioception in Non-Specific Low Back Pain Among Young Adults
- ClinicalTrials.gov ID
- NCT06716515
- Acronym / sponsor ID
- P.T.REC/012/005429
- Conditions
- Non-Specific Chronic Low-back Pain
- Keywords
- Gender Difference, Knee Proprioception, Chronic Non-Specific Low-back Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 4 Dec 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.
the aim of the study is to investigate the impact of gender difference on knee proprioception among non specific low back pain young adults.
Detailed description
Low back pain (LBP) is one of the most common musculoskeletal disorders and the leading causes of disability and work absence globally. LBP notonly causes individual suffering, but also a heavy burden to the society. Despite this, up to 85% patients with LBP cannot be clearly diagnosed and are classified as non-specific LBP (NSLBP). Proprioception plays an important role in the planning of precise and coordinated movements, in maintaining balance and controlling body posture. It also exerts its influence on motor learning and re-education. Proprioception deficit has been identified in people with LBP and it has been suggested that these deficits might be associated with causes and mechanisms of LBP. Although the local investigation of proprioception is important, the proprioceptive deficits due to LBP may not be restricted only to the lumbar region. Anatomical and biomechanical associations between the knee and lower back segments imply that the knee might be adversely affected in patients with LBP.
there is a gap in the literature concerning sex differences in the knee joint proprioception. Although biomechanical and hormonal differences between males and females are suspected to be responsible for increasing this incidence.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Males | – | Device: digital inclinometerForty-one males will be evaluated using digital inclinometer in an open kinetic chain position. The JPS testing is conducted in the sitting position without feet floor contact, at a quiet place with closed eyes . Investigator will perform all the knee joint position sense assessments in the dominant extremity. The digital inclinometer is stabilized to the middle third of the subjects' leg (15 cm distal from the apex of the fibular head) with a strap. The starting position of the test is 90° flexion. The proprioception evaluation angle is defined at 30°. Participants are asked to extend their tested knee to the target angle of 30° from the initial position (90° knee flexion) then to return to their initial position after 5 seconds in this position ,The participant indicated by saying "YES" when they thought they reach the target, and the reposition accuracy will be measured as the joint position error (JPE) in degrees, as displayed on the digital inclinometer screen |
| Females | – | Device: digital inclinometerForty-one females will be assessed the same as group A , Then compare Results To investigate the impact of gender difference on knee proprioception among non specific low back pain young adults |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Age groups
- Adult
- Study population
- Eighty-two Young Adults (include males and females), ranging in age from 18 to 26, will be included in the study. Individuals will be assigned into 2 groups. Group (A) 41 males with non specific low back pain (B) 41 females with non specific low back pain.
Key inclusion criteria (5 listed)
- Forty-one Patients from each gender participated in the study.
- Subject's age ranged from 18-26 years old, with Body Mass Index (BMI) less than 30Kg/m2
- The dominant knees of the subjects (defined as the leg used for kicking) are tested.
- Pain between three and eight using numerical pain rating scale NPRS, and Oswestry Disability Index score less than 20.
- All the subjects sign an informed consent form. 6. able to comprehend and follow the examiner's instructions.
Key exclusion criteria (5 listed)
- limitation of active and passive knee joint motion.
- clinical signs of an impairment or abnormality in the knee (such as abnormal range of motion, muscle weakness, or malalignment).
- injury to the knee that required medical attention.
- current pain in the knee or previous surgery on the knee.
- not able to understand and follow the commands of the examiner.
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 |
|---|---|---|
| digital inclinometerDigital inclinometer to assess gender difference in knee repositioning error | Device | Females, Males |
Primary outcome
knee proprioception
Time frame: up to 4 weeks
knee repositioning error is measured by digital inclinometer
1 secondary outcome
Functional disability
Time frame: up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
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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.
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 Non-Specific Chronic Low-back Pain, run by Cairo 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 5 Dec 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?
This study is still under way. Results are not available in the source record yet.
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?
knee proprioception (time frame: up to 4 weeks). 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 5 Dec 2024.