Lumbar SpondylosisLSNCT06720103
Correlation Between Radiculopathy And Quality Of Life In Patients With Chronic Lumbar Spondylosis
An observational study of Lumbar Spondylosis, run by Cairo University.
Trial summary
This study will be conducted to answer the following question: Is there a Correlation Between Lumbar Radiculopathy and Quality of Life in Patients with chronic lumbar spondylosis? Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Lumbar Spondylosis
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2024to 25 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: one hundred thirty-two subjects (who have chronic lumbar spondylosis); from both genders will participate in this study.
Who may be able to join
- All patient diagnosed and referred from a physician
- Patients suffered from lumbar spondylosis (L4: L5) with radiculopathy more than 3 months
- Participants will be from both gender
- Age will be ranged from 30 to 50.
- BMI of all participants ≤ 30 kg/m2
Who cannot join
- Pregnant and breast-feeding women
- Patients diagnosed with depression and anxiety
- Patient who had undergone lumbar spine surgery
- People with systemic illnesses or physical deformities
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study will be conducted to answer the following question:
Is there a Correlation Between Lumbar Radiculopathy and Quality of Life in Patients with chronic lumbar spondylosis?
Read the detailed description
Spondylosis is an age-related change of vertebrae and discs of the spine. These changes are often called degenerative disc disease and osteoarthritis. When this condition is in the lower back, it's called lumbar spondylosis.
Lumbar osteoarthritis, disc degeneration, degenerative disc disease, and spondylosis are some of the terms used to describe disc changes. In fact, the condition is called spondylosis. Whenever there is a degeneration co-occurrence in the disc, the lumbar spine, the formation of osteophytes and the associated changes in the nerves and the resulting symptoms of pain.Spinal osteoarthritis (OA) is a degenerative process defined radiologically by joint space narrowing, osteophytosis, subchondral sclerosis, and cyst formation.
Osteophytes included within this definition fall into one of the two primary clinical categories.
The first, spondylosis deforms describes bony outgrowths arising primarily along the anterior and lateral perimeters of the vertebral endplate apophyses. These hypertrophic changes are believed to develop at sites of stress to the annular ligament and most commonly occur at thoracic T9-10 and lumbar L3 levels.These conditions lead to nerve root compression, resulting in radiating pain down the leg, commonly referred to as sciatica. The impact of lumbar radiculopathy extends beyond pain, affecting muscle function and neuromuscular control. The involvement of nerve roots such as L4, L5, and S1 can particularly affect the muscles in the lower extremities, including the plantar flexor muscles, which are crucial for movements like walking, running, and maintaining balance
- Conditions
- Lumbar Spondylosis
- Keywords
- quality of life, radiculopathy, lumbar spondylosis
- Medical subject headings
- Spondylosis, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| lumbar spondylosis patients | one hundred thirty-two subjects (who have chronic lumbar spondylosis); from both genders will participate in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
life disability
WHOQOL questionnaire will be used to assess life disability. it is defined as the individual's perception of their QoL. It consists of 24 questions which cover 4 categories plus 2 questions related to scale and health satisfaction. Each individual item of the WHOQOL-BRIEF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale.
Measured: up to one day
Secondary outcomes (2)
sciatic radiculopathy
The straight leg raise test will be used to assess lumbar radiclulopathy..The straight leg raise test is performed with the patient in a supine position. The examiner gently raises the patient's leg by flexing the hip with the knee in extension, and the test is considered positive when the patient experiences pain along the lower limb in the same distribution of the lower radicular nerve roots (usually L5 or S1).
Furthermore, a positive straight leg raise test is determined when pain is elicited by lower limb flexion at an angle lower than 45 degrees. Patients usually request that the examiner abort the maneuver during the test if the pain is reproduced during the leg straightening. The buttock pain is usually relieved by flexing the patient's knee. Additional maneuvers have been described to enhance the test's sensitivity, such as the Bragaad sign, which consists of concomitant foot dorsiflexion to increase the pain while the examiner completes the leg raise
Measured: up to one day
mechanosensitivity of the neuromeningeal structures within the vertebral canal
- The Slump Test: is a neurodynamic test that is believed to evaluate the mechanosensitivity of the neuromeningeal structures within the vertebral canal.To perform the slump test, the patient is placed in an erect sitting position with the knees flexed to 90 and the legs hanging off of the side of the examination table The patient is asked to sit in a slouched position (thoracic and lumbar flexion with a posterior pelvic tilt) and is then requested to actively flex the cervical spine as far as comfortably possible. The clinician/physical therapist then applies gentle overpressure to the upper thoracic and lower cervical spine and maintains this position throughout the examination. The patient's ankle is then passively dorsiflexed to a neutral position while the knee is slowly passively extended until full extension is achieved
Measured: up to one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start20 Dec 2024 (estimated)
- Primary completion25 Feb 2025 (estimated)
- Study completion25 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar SpondylosisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Abdelmageed Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720103
- Sponsor's protocol ID
- P.T.REC/012/005463
- Acronym
- LS
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2024
- Last updated
- 6 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 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Radiculopathy And Quality Of Life In Patients With Chronic Lumbar Spondylosis
- ClinicalTrials.gov ID
- NCT06720103
- Acronym / sponsor ID
- LS / P.T.REC/012/005463
- Conditions
- Lumbar Spondylosis
- Keywords
- quality of life, radiculopathy, lumbar spondylosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 25 Feb 2025 (estimated)
- Study completion
- 25 Feb 2025 (estimated)
- First posted
- 6 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.
This study will be conducted to answer the following question:
Is there a Correlation Between Lumbar Radiculopathy and Quality of Life in Patients with chronic lumbar spondylosis?
Detailed description
Spondylosis is an age-related change of vertebrae and discs of the spine. These changes are often called degenerative disc disease and osteoarthritis. When this condition is in the lower back, it's called lumbar spondylosis.
Lumbar osteoarthritis, disc degeneration, degenerative disc disease, and spondylosis are some of the terms used to describe disc changes. In fact, the condition is called spondylosis. Whenever there is a degeneration co-occurrence in the disc, the lumbar spine, the formation of osteophytes and the associated changes in the nerves and the resulting symptoms of pain.Spinal osteoarthritis (OA) is a degenerative process defined radiologically by joint space narrowing, osteophytosis, subchondral sclerosis, and cyst formation.
Osteophytes included within this definition fall into one of the two primary clinical categories.
The first, spondylosis deforms describes bony outgrowths arising primarily along the anterior and lateral perimeters of the vertebral endplate apophyses. These hypertrophic changes are believed to develop at sites of stress to the annular ligament and most commonly occur at thoracic T9-10 and lumbar L3 levels.These conditions lead to nerve root compression, resulting in radiating pain down the leg, commonly referred to as sciatica. The impact of lumbar radiculopathy extends beyond pain, affecting muscle function and neuromuscular control. The involvement of nerve roots such as L4, L5, and S1 can particularly affect the muscles in the lower extremities, including the plantar flexor muscles, which are crucial for movements like walking, running, and maintaining balance
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lumbar spondylosis patients | – | –one hundred thirty-two subjects (who have chronic lumbar spondylosis); from both genders will participate in this group. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- one hundred thirty-two subjects (who have chronic lumbar spondylosis); from both genders will participate in this study.
Key inclusion criteria (5 listed)
- All patient diagnosed and referred from a physician
- Patients suffered from lumbar spondylosis (L4: L5) with radiculopathy more than 3 months
- Participants will be from both gender
- Age will be ranged from 30 to 50.
- BMI of all participants ≤ 30 kg/m2
Key exclusion criteria (4 listed)
- Pregnant and breast-feeding women
- Patients diagnosed with depression and anxiety
- Patient who had undergone lumbar spine surgery
- People with systemic illnesses or physical deformities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
life disability
Time frame: up to one day
WHOQOL questionnaire will be used to assess life disability. it is defined as the individual's perception of their QoL. It consists of 24 questions which cover 4 categories plus 2 questions related to scale and health satisfaction. Each individual item of the WHOQOL-BRIEF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale.
2 secondary outcomes
sciatic radiculopathy
Time frame: up to one day
mechanosensitivity of the neuromeningeal structures within the vertebral canal
Time frame: up to one day
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 6 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spondylosis, 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 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: opening soon, as of the sponsor's last update on 6 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?
Contact mona Ali, master (01119882871, monaaly1995@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
life disability (time frame: up to one day). 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 6 Dec 2024.