The Impact of Paraspinal Muscle Atrophy in Spine Surgeries
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
The goal of this observational study is to learn about the role of pre-operative paraspinal muscle atrophy in outcomes of lumbar spine fusion surgeries in patients with degenerative lumbar spine diseases. The main question it aims to answer is:
Does paraspinal muscle atrophy worsen lumbar spine fusion surgeries outcomes? Participants undergoing lumbar spine fusion surgeries as part of their treatment for degenerative lumbar spine diseases will answer survey questions about their low back pain and daily activities for 1 year.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with degenerative lumbar spine diseases undergoing lumbar spinal fusion.
Disqualifiers
Long-level fusion ≥ 3 levels.
History of previous lumbar surgery.
Patients diagnosed with spondylolysis.
Other pathological conditions such as fractures, infections or tumors.
Trial population
Patients undergoing lumbar spinal fusion at Assiut University Hospitals, Department of Orthopedic surgery and Traumatology.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Oswerty disability index Arabic version (ODI)
The Oswestry Disability Index (ODI) translates low back pain disability into a numerical score for better understanding and communication. It's a questionnaire used to assess the impact of low back pain on a person's daily life, work, and ability to perform specific tasks. The ODI translates into a score from 0-100, with higher scores indicating greater disability. This score helps clinicians and researchers quantify the functional disability caused by low back pain.
Time frame
Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.Secondary outcomes
1
Visual analogue scale (VAS)
A Visual Analogue Scale (VAS) is a measurement tool used to assess subjective experiences like pain or discomfort by having a person mark a point on a continuous line representing the range from "no pain" to "worst imaginable pain". Zero is equivalent to no pain and 10 indicates the worst possible pain.
Time frame
Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.2
Local kyphotic angle
In the context of degenerative spine disease, the local kyphotic angle refers to the increased forward curvature (kyphosis) at a specific level of the spine, often between two adjacent vertebral bodies. This local kyphosis can result from various factors, including vertebral collapse, disc degeneration, or changes in vertebral shape associated with aging. The local kyphotic angle is typically measured using X-ray images, with the angle formed by the upper and lower endplates of the vertebral bodies.
Time frame
Baseline, 1 day postoperative, 6 months postoperative and 1 year postoperative.3
Lumbar lordosis
In degenerative lumbar spine disease, the normal inward curve of the lower back (lumbar lordosis) can change. This change can manifest as a loss of lordosis (flattening of the curve) or an increase in lordosis (excessive curve). It is measured using X-rays of lateral view of lumbar spine by using the lumbosacral angle (LSA), which is the angle between the top of L1 (the first lumbar vertebra) and the top of the sacrum. The Cobb angle method, using lines drawn along the superior endplates of L1 and S1.
Time frame
Baseline, 1 day postoperative, 6 months postoperative and 1 year postoperative.4
EuroQol-5-dimension 5-level Arabic version (EQ-5D-5L)
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire measures health-related quality of life by assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. These levels range from "no problems" to "extreme problems" and the responses are combined to create a unique health state profile.
Time frame
Baseline, 2 weeks postoperative, 6 weeks postoperative, 3 months postoperative, 6 months postoperative and 1 year postoperative.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: