NCT06407167

Neuropathic Pain in Patients With Degenerative Lumbar Stenosis

Observational Cohort Study of the Neuropathic Pain in Surgical Treatment of Patients With Degenerative Lumbar Stenosis

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: N.N. Priorov National Medical Research Center of Traumatology and Orthopedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pre- and postoperative pain in patients with degenerative stenosis requires great attention, as it can mislead the doctor about treatment tactics. Neuropathic pain in the legs before and after the surgical procedure, as well as the residual or recurrent pain syndrome existing against this background, overshadow the patient's recovery and cast doubt on the fullness of the performed decompression. Neural compression in the spinal canal and back pain may be the cause of the patient's antalgic posture and sagittal imbalance as seen on X-Ray, to need for corrective interventions surgical procedure. Thus, it is necessary to clarify the role and the influence of the pain and its type on the perioperative period in patients with degenerative lumbar spinal stenosis.

Detailed description

The current study is prospective observational study to evaluate the role of pain syndrome including neuropathic pain in surgical outcomes in patients with degenerative lumbar spinal stenosis. This study will be conducted at Priorov Central Institute for Trauma and Orthopedics, Moscow, Russia. The study is expected to enroll at least 120 adult patients with degenerative lumbar stenosis. The neuropathy will be assessed preoperatively, and then the patient will undergo decompressive lumbar surgery without fusion. The neuropathic pain will be evaluated according to DN4 preoperatively, each patient will be assigned to one of two groups depending on the total value of DN4 - with the presence of neuropathy (DN4\>= 4) and without neuropathy (DN4 \<4). Postoperative evaluation will include 2 visits during one year to evaluate clinical and radiological outcomes.

Conditions

• Lumbar Spinal Stenosis
• Neuropathic Pain
• Spinal Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	DN4 (Douleur Neuropathique 4 Questions) questionnaire	DN4 includes a series of ten questions consisting of both sensory descriptors and signs related to bedside sensory examination

Timeline

• Start date: 2024-05-13
• Primary completion: 2025-05-16
• Completion: 2026-05-13
• First posted: 2024-05-09
• Last updated: 2025-08-20

Locations

1 site across 1 country: Russia