Lumbar Disc DiseaseNCT07516613
Clinical and MRI Findings in Lumbar Disc Disease
An observational study of Lumbar Disc Disease and Low Back Pain, run by Assiut University.
Trial summary
Low back pain related to lumbar disc disease is a very common condition. Doctors frequently use Magnetic Resonance Imaging (MRI) to look at the spine and diagnose these problems. However, it is not always clear how well the severity of the damage seen on an MRI matches the actual symptoms a patient is experiencing. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbar Disc Disease, Low Back Pain, Lumbar Disc Herniation
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to May 2027
- 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 70 years
- All sexes
- Adult, Older adult
Study population: The study population consists of adult patients, aged 18 to 70 years, who present to the outpatient clinics and inpatient wards of the Orthopedic Surgery Department at Assiut University Hospital. Eligible individuals must exhibit clinical symptoms indicative of lumbar disc disease, such as low back pain with or without radiculopathy, and possess MRI-confirmed lumbar disc pathology (e.g., disc bulge, protrusion, extrusion, or sequestration) documented within the past 3 months.
Who may be able to join
- Adult patients aged 18-70 years presenting with clinical symptoms suggestive of lumbar disc disease (low back pain with or without radiculopathy).
- Patients with MRI-confirmed lumbar disc pathology (disc bulge, protrusion, extrusion, or sequestration) at one or more levels.
- Patients who have had lumbar MRI performed within 3 months prior to enrollment.
- Patients able to communicate clearly and complete assessment questionnaires.
- Patients providing written informed consent to participate in the study.
Who cannot join
- Patients with previous lumbar spine surgery.
- Patients with spinal fractures, tumors, infections, or inflammatory spondyloarthropathies (e.g., ankylosing spondylitis).
- Patients with severe psychiatric disorders that interfere with assessment.
- Patients with contraindications to MRI (e.g., pacemakers, metallic implants).
- Patients with cauda equina syndrome requiring emergency surgical intervention.
- Patients with peripheral neuropathy from systemic causes (e.g., diabetes mellitus with confirmed neuropathy, renal failure).
- Pregnant women.
- Patients who refuse to participate or provide informed consent.
About this study
Official title: Correlation Between Clinical Parameters and MRI Imaging Findings in Lumbar Disc Disease
Low back pain related to lumbar disc disease is a very common condition. Doctors frequently use Magnetic Resonance Imaging (MRI) to look at the spine and diagnose these problems. However, it is not always clear how well the severity of the damage seen on an MRI matches the actual symptoms a patient is experiencing. Sometimes, patients with severe MRI findings have mild symptoms, and vice versa.
The purpose of this observational study is to understand the relationship between a patient's clinical symptoms and their MRI results. Researchers want to see if the severity of the spinal damage shown on an MRI can accurately predict how much pain or disability a patient has.
Read more
Participants in this study are adults (ages 18-70) who are already experiencing symptoms of lumbar disc disease and have recently had an MRI. During the study, participants will:
- Complete a questionnaire about the intensity of their back and leg pain.
- Fill out a survey about how their back pain affects their daily activities.
- Undergo a standard physical and neurological examination by a doctor to check their reflexes, muscle strength, and sensation.
Researchers will then compare these physical examination and questionnaire results with the detailed findings from the patient's MRI scans. The goal of this research is to improve diagnostic accuracy and help doctors make better, more personalized treatment decisions for future patients with lower back pain.
Read the detailed description
Low back pain caused by lumbar disc disease is a major cause of disability globally. While Magnetic Resonance Imaging (MRI) is the gold standard for diagnosing disc pathology, there is a debate regarding the correlation between the structural abnormalities seen on an MRI and the actual clinical symptoms experienced by the patient. Frequent discordance between imaging severity and clinical presentation can create diagnostic uncertainty, potentially leading to over-investigation or inappropriate surgical referrals.
This research is a cross-sectional observational study designed to address this diagnostic uncertainty by systematically mapping clinical parameters to corresponding MRI characteristics. The study will be conducted at the Orthopedic surgery department in Assiut University hospital.
Upon enrollment, participants will undergo a comprehensive clinical assessment. A sociodemographic and medical history will be collected. Pain intensity will be evaluated using the Visual Analog Scale (VAS) independently for both back and leg pain. Functional disability will be measured using the validated Arabic version of the Oswestry Disability Index (ODI). An attending physician will perform a standardized neurological examination to assess motor power using the Medical Research Council (MRC) grading scale, sensory deficits, deep tendon reflexes, and specific nerve root irritation tests including the Straight Leg Raise Test (SLRT), Crossed SLR, and Femoral stretch test. Lumbosacral range of motion will also be measured using a goniometer.
Following the clinical evaluation, all patients will undergo a standardized lumbar spine MRI using a 1.5 Tesla scanner. To eliminate bias, the MRI studies will be reported by a qualified consultant radiologist who is blinded to the patient's clinical findings. The radiologist will evaluate multiple parameters, including disc herniation morphology (classified per NASS guidelines), disc degeneration (using the Pfirrmann grading system), thecal sac compression, nerve root compression, central and foraminal stenosis, and Modic endplate changes.
- Keywords
- Magnetic Resonance Imaging (MRI), Visual Analog Scale (VAS), Oswestry Disability Index (ODI), Pfirrmann Grading System, Nerve Root Compression, Spinal Canal Stenosis, Disc Degeneration
- Medical subject headings
- Intervertebral disc disease, Low Back Pain, Intervertebral Disc Displacement, Radiculopathy, Spinal Stenosis, Intervertebral Disc Degeneration
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 |
|---|---|---|
| Patients with Lumbar Disc Disease | Adult patients aged 18-70 years presenting with clinical symptoms suggestive of lumbar disc disease (low back pain with or without radiculopathy) and MRI-confirmed lumbar disc pathology. These participants will undergo standard clinical evaluations, including pain (VAS) and disability (ODI) assessments, alongside a standardized lumbar spine MRI to correlate clinical parameters with imaging findings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between MRI Disc Herniation Grade and Visual Analog Scale (VAS) Score for Back Pain
This outcome evaluates the statistical correlation between the severity of lumbar disc herniation on an MRI and the patient's self-reported back pain intensity. Pain intensity is measured using a 10 cm Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents the "worst imaginable pain" (higher scores indicate worse pain). The MRI disc herniation is independently graded by a radiologist based on morphology (bulge, protrusion, extrusion, or sequestration). The final measure is the correlation coefficient between the clinical VAS score and the radiological herniation grade.
Measured: Day 0 (At the time of clinical assessment and MRI evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Mokhlis Momtaz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516613
- Sponsor's protocol ID
- MRI & Clinical in Lumbar Disc
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Clinical Parameters and MRI Imaging Findings in Lumbar Disc Disease
- ClinicalTrials.gov ID
- NCT07516613
- Acronym / sponsor ID
- MRI & Clinical in Lumbar Disc
- Keywords
- Magnetic Resonance Imaging (MRI), Visual Analog Scale (VAS), Oswestry Disability Index (ODI), Pfirrmann Grading System, Nerve Root Compression, Spinal Canal Stenosis, Disc Degeneration
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Apr 2026 (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 related to lumbar disc disease is a very common condition. Doctors frequently use Magnetic Resonance Imaging (MRI) to look at the spine and diagnose these problems. However, it is not always clear how well the severity of the damage seen on an MRI matches the actual symptoms a patient is experiencing. Sometimes, patients with severe MRI findings have mild symptoms, and vice versa.
The purpose of this observational study is to understand the relationship between a patient's clinical symptoms and their MRI results. Researchers want to see if the severity of the spinal damage shown on an MRI can accurately predict how much pain or disability a patient has.
Participants in this study are adults (ages 18-70) who are already experiencing symptoms of lumbar disc disease and have recently had an MRI. During the study, participants will:
- Complete a questionnaire about the intensity of their back and leg pain.
- Fill out a survey about how their back pain affects their daily activities.
- Undergo a standard physical and neurological examination by a doctor to check their reflexes, muscle strength, and sensation.
Researchers will then compare these physical examination and questionnaire results with the detailed findings from the patient's MRI scans. The goal of this research is to improve diagnostic accuracy and help doctors make better, more personalized treatment decisions for future patients with lower back pain.
Detailed description
Low back pain caused by lumbar disc disease is a major cause of disability globally. While Magnetic Resonance Imaging (MRI) is the gold standard for diagnosing disc pathology, there is a debate regarding the correlation between the structural abnormalities seen on an MRI and the actual clinical symptoms experienced by the patient. Frequent discordance between imaging severity and clinical presentation can create diagnostic uncertainty, potentially leading to over-investigation or inappropriate surgical referrals.
This research is a cross-sectional observational study designed to address this diagnostic uncertainty by systematically mapping clinical parameters to corresponding MRI characteristics. The study will be conducted at the Orthopedic surgery department in Assiut University hospital.
Upon enrollment, participants will undergo a comprehensive clinical assessment. A sociodemographic and medical history will be collected. Pain intensity will be evaluated using the Visual Analog Scale (VAS) independently for both back and leg pain. Functional disability will be measured using the validated Arabic version of the Oswestry Disability Index (ODI). An attending physician will perform a standardized neurological examination to assess motor power using the Medical Research Council (MRC) grading scale, sensory deficits, deep tendon reflexes, and specific nerve root irritation tests including the Straight Leg Raise Test (SLRT), Crossed SLR, and Femoral stretch test. Lumbosacral range of motion will also be measured using a goniometer.
Following the clinical evaluation, all patients will undergo a standardized lumbar spine MRI using a 1.5 Tesla scanner. To eliminate bias, the MRI studies will be reported by a qualified consultant radiologist who is blinded to the patient's clinical findings. The radiologist will evaluate multiple parameters, including disc herniation morphology (classified per NASS guidelines), disc degeneration (using the Pfirrmann grading system), thecal sac compression, nerve root compression, central and foraminal stenosis, and Modic endplate changes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Lumbar Disc Disease | – | –Adult patients aged 18-70 years presenting with clinical symptoms suggestive of lumbar disc disease (low back pain with or without radiculopathy) and MRI-confirmed lumbar disc pathology. These participants will undergo standard clinical evaluations, including pain (VAS) and disability (ODI) assessments, alongside a standardized lumbar spine MRI to correlate clinical parameters with imaging findings. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients, aged 18 to 70 years, who present to the outpatient clinics and inpatient wards of the Orthopedic Surgery Department at Assiut University Hospital. Eligible individuals must exhibit clinical symptoms indicative of lumbar disc disease, such as low back pain with or without radiculopathy, and possess MRI-confirmed lumbar disc pathology (e.g., disc bulge, protrusion, extrusion, or sequestration) documented within the past 3 months.
Key inclusion criteria (5 listed)
- Adult patients aged 18-70 years presenting with clinical symptoms suggestive of lumbar disc disease (low back pain with or without radiculopathy).
- Patients with MRI-confirmed lumbar disc pathology (disc bulge, protrusion, extrusion, or sequestration) at one or more levels.
- Patients who have had lumbar MRI performed within 3 months prior to enrollment.
- Patients able to communicate clearly and complete assessment questionnaires.
- Patients providing written informed consent to participate in the study.
Key exclusion criteria (8 listed)
- Patients with previous lumbar spine surgery.
- Patients with spinal fractures, tumors, infections, or inflammatory spondyloarthropathies (e.g., ankylosing spondylitis).
- Patients with severe psychiatric disorders that interfere with assessment.
- Patients with contraindications to MRI (e.g., pacemakers, metallic implants).
- Patients with cauda equina syndrome requiring emergency surgical intervention.
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
Correlation Between MRI Disc Herniation Grade and Visual Analog Scale (VAS) Score for Back Pain
Time frame: Day 0 (At the time of clinical assessment and MRI evaluation)
This outcome evaluates the statistical correlation between the severity of lumbar disc herniation on an MRI and the patient's self-reported back pain intensity. Pain intensity is measured using a 10 cm Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents the "worst imaginable pain" (higher scores indicate worse pain). The MRI disc herniation is independently graded by a radiologist based on morphology (bulge, protrusion, extrusion, or sequestration). The final measure is the correlation coefficient between the clinical VAS score and the radiological herniation grade.
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 8 Apr 2026.
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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 Lumbar Disc Disease and Low Back Pain, run by Assiut 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 8 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 8 Apr 2026. 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?
Correlation Between MRI Disc Herniation Grade and Visual Analog Scale (VAS) Score for Back Pain (time frame: Day 0 (At the time of clinical assessment and MRI evaluation)). 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 8 Apr 2026.