Clinical and MRI Findings in Lumbar Disc Disease

April 1, 2026 updated by: Mina Mokhlis Momtaz, Assiut University

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

96

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 (At the time of clinical assessment and MRI evaluation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRI & Clinical in Lumbar Disc

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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