Evaluating neuropathic pain in patients with degenerative lumbar stenosis
Observational Cohort Study of the Neuropathic Pain in Surgical Treatment of Patients With Degenerative Lumbar Stenosis
This study is trying to see how neuropathic pain affects recovery after surgery in adults with degenerative lumbar stenosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | N.N. Priorov National Medical Research Center of Traumatology and Orthopedics Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06407167 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of neuropathic pain on surgical outcomes in patients undergoing decompressive surgery for degenerative lumbar stenosis. It will enroll at least 120 adult patients, evaluating their pain using the DN4 questionnaire both preoperatively and postoperatively. Patients will be categorized based on their neuropathy status, and outcomes will be monitored through clinical and radiological evaluations over the course of one year. The study is being conducted at the Priorov Central Institute for Trauma and Orthopedics in Moscow, Russia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-85 with radicular leg pain and planned decompressive surgery for degenerative lumbar stenosis.
Not a fit: Patients with prior lumbar fusion or significant neurological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve understanding of how neuropathic pain affects recovery and treatment strategies for patients with lumbar stenosis.
How similar studies have performed: While similar studies have explored pain management in spinal conditions, this specific approach focusing on neuropathic pain in the context of lumbar stenosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-85 years; 2. Radicular leg pain with or without neurogenic claudication with or without back pain; 3. Planned decompressive surgery for degenerative lumbar stenosis with or without degenerative spondylolisthesis; 4. Symptoms persisting for at least 3 months prior to surgery; 5. Given written Informed Consent; 6. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements Exclusion Criteria: 1. Prior lumbar fusion at any level; 2. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol; 3. Back or non-radicular pain of unknown etiology; 4. History or presence of any other major neurological disease or condition that may interfere with the study assessments (e.g. significant peripheral neuropathy, multiply sclerosis); 5. Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study; 6. Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
Where this trial is running
Moscow
- Priorov National Medical Research Center of Traumatology and Orthopedics — Moscow, Russian Federation (Recruiting)
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.