Neuropathic Pain in Patients With Degenerative Lumbar Stenosis

Last updated: August 14, 2025
Sponsor: N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Acute Pain

Oral Facial Pain

Chronic Pain

Treatment

DN4 (Douleur Neuropathique 4 Questions) questionnaire

Clinical Study ID

NCT06407167
NS12-02
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-85 years;

  2. Radicular leg pain with or without neurogenic claudication with or without backpain;

  3. Planned decompressive surgery for degenerative lumbar stenosis with or withoutdegenerative 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 tofollow-up schedule and requirements

Exclusion

Exclusion Criteria:

  1. Prior lumbar fusion at any level;

  2. Any contraindication or inability to undergo baseline and/or follow up MRI or X-rayas 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 mayinterfere with the study assessments (e.g. significant peripheral neuropathy,multiply sclerosis);

  5. Any other condition or situation that the investigator believes may interfere withthe 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 inanother study (in parallel to this study).

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: DN4 (Douleur Neuropathique 4 Questions) questionnaire
Phase:
Study Start date:
May 13, 2024
Estimated Completion Date:
May 13, 2026

Study 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.

Connect with a study center

  • Priorov National Medical Research Center of Traumatology and Orthopedics

    Moscow, 127299
    Russian Federation

    Site Not Available

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