Neuropathic Pain in Patients With Degenerative Lumbar Stenosis

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

Status: Active, not recruiting

Conditions: Lumbar Spinal Stenosis; Spinal Disease; Neuropathic Pain

Treatments: Diagnostic Test: DN4 (Douleur Neuropathique 4 Questions) questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT06407167

NS12-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

120 participants in 2 patient groups

Neuropathic Pain

Description:

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

Treatment:

Diagnostic Test: DN4 (Douleur Neuropathique 4 Questions) questionnaire

No Neuropathic Pain

Description:

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

Treatment:

Diagnostic Test: DN4 (Douleur Neuropathique 4 Questions) questionnaire