Evaluating the reliability of flexion-extension radiographs for spinal instability diagnosis
Evaluating the Test-retest Reliability of a Standardized Flexion - Extension Radiograph Imaging Protocol for the Lumbar Spine.
This study is testing a new way to take X-rays of the lower back to help doctors more accurately decide if surgery is needed for patients with spinal stenosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rijnstate Hospital Academic / other |
| Locations | 2 sites (Arnhem, Gelderland and 1 other locations) |
| Trial ID | NCT05633550 on ClinicalTrials.gov |
What this trial studies
This observational study aims to standardize the flexion-extension radiograph imaging protocol used to assess lumbar spinal instability in patients with lumbar spinal stenosis. By controlling the quality and consistency of these radiographs, the study seeks to improve the reliability of diagnostic measurements related to intervertebral motion. Orthopedic surgeons often rely on personal experience to determine the need for additional fusion surgery during decompression procedures, and this study aims to provide a more objective assessment tool. The ultimate goal is to facilitate better surgical decision-making and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are experiencing back or leg pain and require lumbar spine radiographs for diagnosis.
Not a fit: Patients with prior lumbar spinal surgery, significant spinal deformities, or those unable to comply with study protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of spinal instability, guiding better treatment decisions for patients with lumbar spinal stenosis.
How similar studies have performed: While the approach of standardizing imaging protocols is not widely tested, the need for reliable diagnostic assessments in spinal instability is recognized, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * referral to the orthopaedic surgeon because of pain in the back or leg and requiring lumbar spine radiographs so the orthopaedic surgeon is able to diagnose the probable cause of the pain. * over the age of 18 years * ability to flex and extend the spine sufficiently to facilitate acceptable flexion and extension radiographs. Exclusion Criteria: * any form of spine-related traumatic injury * prior lumbar spinal surgery * lateral spondylolisthesis or coronal plane curvature in the lumbar spine of \>10° * the presence of involuntary back muscle spasms * the presence of significant changes in pain during the day * inability to understand and sign the study Informed Consent form * inability to follow oral instructions
Where this trial is running
Arnhem, Gelderland and 1 other locations
- Rijnstate Hospital — Arnhem, Gelderland, Netherlands (Recruiting)
- Olvg — Amsterdam, Netherlands (Not_yet_recruiting)
Study contacts
- Principal investigator: Job LC van Susante, Dr. PhD. — Department of orthopedics, Rijnstate Hospital
- Study coordinator: Joey FH Reijmer, Drs.
- Email: jreijmer@rijnstate.nl
- Phone: 088 - 005 7744
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.