Efficacy of Mechanical Traction and Spinal Decompression Treatments in Patients With Low Back Pain
NCT05617924
Back Pain, Bone Diseases
Afyonkarahisar, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT07516613
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Observational
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Assiut University
Other
Correlation Between Clinical Parameters and MRI Imaging Findings in Lumbar Disc Disease
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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