Evaluating a single-question measure for lumbar discectomy outcomes
The Single Assessment Numeric Evaluation (SANE): Is a Reliable Metric to Measure Clinically Significant Improvements After Lumbar Discectomy
Windsor-Essex Compassionate Care Community · NCT05070078
This study is testing a simple one-question survey to see if it can effectively measure how well people feel after having surgery for a herniated disc in their lower back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Windsor-Essex Compassionate Care Community (other) |
| Locations | 1 site (Windsor, Ontario) |
| Trial ID | NCT05070078 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the Single Assessment Numeric Evaluation (SANE), a one-question patient-reported outcome measure designed to assess functional health in patients undergoing lumbar discectomy. The SANE score allows patients to rate their function on a scale from 0 to 100, aiming to reduce survey fatigue and improve data integrity compared to traditional, longer questionnaires. By validating the SANE in this specific surgical context, the study seeks to streamline the assessment process while maintaining the quality of patient-reported outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are scheduled to undergo lumbar discectomy.
Not a fit: Patients with a history of lumbar surgery, those under 18, or individuals with specific complications such as cauda equina syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could simplify outcome assessments for patients undergoing lumbar discectomy, leading to better patient engagement and more reliable data.
How similar studies have performed: Other studies have shown success with similar single-question outcome measures in orthopedic contexts, suggesting potential for this approach in lumbar discectomy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 18 years of age undergoing a lumbar discectomy. Exclusion Criteria: * Previous history of lumbar surgery. * Pediatric age group. * Patients with a postoperative follow-up time of less than 1 year. * Unstable patients in need of fixation. * Patients with cauda equina syndrome. * Non-compliant patients.
Where this trial is running
Windsor, Ontario
- Windsor Regional Hospital - Ouellette — Windsor, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Mohamed Soliman — Cairo University
- Study coordinator: Mohamed Soliman, MD
- Email: moh.ar.sol@kasralainy.edu.eg
- Phone: 17329241637
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.
Conditions: Lumbar Discectomy, Single Assessment Numeric Evaluation, Patient Reported Outcome Measures