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Active, Not Recruiting

NCT Number: NCT06407167

Neuropathic Pain in 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Disease Spinal Diseases Spinal Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Priorov National Medical Research Center of Traumatology and Orthopedics

Moscow, 127299, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

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

Other names: neuropathic pain diagnostic questionnaire

Primary outcomes

  1. Change from baseline in Oswestry Disability Index (ODI)

    Time frame: 3 months postoperatively

    To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms

Secondary outcomes

  1. Change from baseline in Neuropathic Pain 4 Questions (DN4)

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

    To observe the change of Neuropathic Pain 4 Questions as compared to baseline through follow-up terms

  2. Change from baseline in Numeric Pain Rating Scale (NPRS)

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

    To observe the change of Numeric Pain Rating Scale as compared to baseline through follow-up terms

  3. Change from baseline in Oswestry Disability Index (ODI)

    Time frame: 12 months postoperatively

    To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms

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

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

    To observe the change of The Health Transition Item as compared to baseline through follow-up terms

  5. Change from baseline in sagittal balance parameters

    Time frame: 3 months, 12 months postoperatively

    To observe the change of sagittal balance parameters (index Barrey) as compared to baseline through follow-up terms

  6. Change from baseline in regional balance parameters

    Time frame: 3 months, 12 months postoperatively

    To observe the change of regional balance parameters (Segmental Lordosis) as compared to baseline through follow-up terms

  7. Change from baseline in frontal balance parameters

    Time frame: 3 months, 12 months postoperatively

    To observe the change of frontal balance parameters (Cobb's angle) as compared to baseline through follow-up terms

  8. the safety parameters

    Time frame: during study, an average of 1 year

    To observe and document the safety parameters (Adverse events)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 9, 2024
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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