Neuropathic Pain in Patients With Degenerative Lumbar Stenosis

NCT ID: NCT06407167

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-13
• Study Completion Date: 2026-05-13

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Neuropathic Pain

All patients will undergo lumbar decompression at stenosis levels (clinically and MRI confirmed) regardless of study group

DN4 (Douleur Neuropathique 4 Questions) questionnaire

Intervention Type: DIAGNOSTIC_TEST

DN4 includes a series of ten questions consisting of both sensory descriptors and signs related to bedside sensory examination

No Neuropathic Pain

All patients will undergo lumbar decompression at stenosis levels (clinically and MRI confirmed) regardless of study group

DN4 (Douleur Neuropathique 4 Questions) questionnaire

Intervention Type: DIAGNOSTIC_TEST

DN4 includes a series of ten questions consisting of both sensory descriptors and signs related to bedside sensory examination

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

neuropathic pain diagnostic questionnaire

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

N.N. Priorov National Medical Research Center of Traumatology and Orthopedics

OTHER

Sponsor Role: lead

Responsible Party

Aleksandr Krutko

Head of Neurosurgery Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Priorov National Medical Research Center of Traumatology and Orthopedics

Moscow, , Russia

Countries

Russia

Other Identifiers

NS12-02

Identifier Type: -

Identifier Source: org_study_id