Clinical and MRI Findings in Lumbar Disc Disease

NCT07516613 | Not Yet Recruiting

• 1 other identifier: MRI & Clinical in Lumbar Disc
• Study Type: observational
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

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

Keywords

Magnetic Resonance Imaging (MRI); Visual Analog Scale (VAS); Oswestry Disability Index (ODI); Pfirrmann Grading System; Nerve Root Compression; Spinal Canal Stenosis; Disc Degeneration

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0 (At the time of clinical assessment and MRI evaluation)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Intervertebral disc disease; Low Back Pain; Intervertebral Disc Displacement; Radiculopathy; Spinal Stenosis; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Orthopedic Surgery Department, Assiut University

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04