Clinical and MRI Findings in Lumbar Disc Disease

Assiut University

Status: Not yet enrolling

Conditions: Lumbar Disc Herniation; Lumbosacral Radiculopathy; Low Back Pain; Lumbar Disc Disease

Study type: Observational

Funder types: Other

Identifiers

NCT07516613

MRI & Clinical in Lumbar Disc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

96 participants in 1 patient group

Patients with Lumbar Disc Disease

Description:

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.