Neuropathic Pain in Patients With Degenerative Lumbar Stenosis

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neuropathic Pain; Lumbar Spinal Stenosis; Spinal Disease
• Intervention / Treatment: Diagnostic test: DN4 (Douleur Neuropathique 4 Questions) questionnaire

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 127299
    • Priorov National Medical Research Center of Traumatology and Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

One study center in Russia will include adult patients with radicular leg pain with/without neurogenic claudication with/without back pain caused by degenerative spinal stenosis with MRI-confirmed nerve compression; with symptoms persisting for more than 3 months before surgery.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neuropathic Pain; All patients will undergo lumbar decompression at stenosis levels (clinically and MRI confirmed) regardless of study group	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; Other Names: neuropathic pain diagnostic questionnaire
No Neuropathic Pain; All patients will undergo lumbar decompression at stenosis levels (clinically and MRI confirmed) regardless of study group	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; Other Names: neuropathic pain diagnostic questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Oswestry Disability Index (ODI)	To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms	3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Neuropathic Pain 4 Questions (DN4)	To observe the change of Neuropathic Pain 4 Questions as compared to baseline through follow-up terms	2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in Numeric Pain Rating Scale (NPRS)	To observe the change of Numeric Pain Rating Scale as compared to baseline through follow-up terms	2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in Oswestry Disability Index (ODI)	To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms	12 months postoperatively
Change from baseline in The Health Transition Item from SF-36 (HTI Item)	To observe the change of The Health Transition Item as compared to baseline through follow-up terms	2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in sagittal balance parameters	To observe the change of sagittal balance parameters (index Barrey) as compared to baseline through follow-up terms	3 months, 12 months postoperatively
Change from baseline in regional balance parameters	To observe the change of regional balance parameters (Segmental Lordosis) as compared to baseline through follow-up terms	3 months, 12 months postoperatively
Change from baseline in frontal balance parameters	To observe the change of frontal balance parameters (Cobb's angle) as compared to baseline through follow-up terms	3 months, 12 months postoperatively
the safety parameters	To observe and document the safety parameters (Adverse events)	during study, an average of 1 year

Collaborators and Investigators

• Sponsor: N.N. Priorov National Medical Research Center of Traumatology and Orthopedics

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Actual): May 16, 2025
• Study Completion (Estimated): May 13, 2026

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Neuromuscular Diseases; Peripheral Nervous System Diseases; Constriction, Pathologic; Spinal Stenosis; Neuralgia; Spinal Diseases
• Other Study ID Numbers: NS12-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No