Neuropathic Pain in Patients With Degenerative Lumbar Stenosis

NCT06407167 | Active Not Recruiting

• 1 other identifier: NS12-02
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis; Neuropathic Pain; Spinal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change from baseline in Neuropathic Pain 4 Questions (DN4)

  2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively

• Change from baseline in Numeric Pain Rating Scale (NPRS)

  2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively

• Change from baseline in Oswestry Disability Index (ODI)

  12 months postoperatively

• Change from baseline in The Health Transition Item from SF-36 (HTI Item)

  2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively

• Change from baseline in sagittal balance parameters

  3 months, 12 months postoperatively

Study Arms (2)

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

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

Interventions

DN4 (Douleur Neuropathique 4 Questions) questionnaire DIAGNOSTIC_TEST

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

Also known as: neuropathic pain diagnostic questionnaire

Neuropathic Pain; No Neuropathic Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 18-85 years;
• Radicular leg pain with or without neurogenic claudication with or without back pain;
• Planned decompressive surgery for degenerative lumbar stenosis with or without degenerative spondylolisthesis;
• Symptoms persisting for at least 3 months prior to surgery;
• Given written Informed Consent;
• Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements

You may not qualify if:

• Prior lumbar fusion at any level;
• Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
• Back or non-radicular pain of unknown etiology;
• 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);
• 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;
• Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).

Sponsors & Collaborators

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

Study Sites (1)

Priorov National Medical Research Center of Traumatology and Orthopedics

Moscow, 127299, Russia

Location

MeSH Terms

Conditions

Spinal Stenosis; Neuralgia; Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurosurgery Department

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 9, 2024
• Study Start: May 13, 2024
• Primary Completion: May 16, 2025
• Study Completion (Estimated): May 13, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)