An observational study in Lumbar Disc Disease, Low Back Pain and Lumbar Disc Herniation, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Assiut University · Observational
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:
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.
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.
63 studies on the registry are indexed under Intervertebral disc disease; 18 are open to participants now.
This study's planned enrollment of 96 is below the median of 120 across 22 observational studies indexed under Intervertebral disc disease.
Browse Intervertebral disc disease studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Day 0 (At the time of clinical assessment and MRI evaluation)
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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