Neuropathic Pain in Patients With Degenerative Lumbar Stenosis

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06407167
• Other study ID #: NS12-02
• Status: Recruiting
• Start date: May 13, 2024
• Est. completion date: May 13, 2026

Study information

• Verified date: May 2024
• Source: N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 13, 2026
• Est. primary completion date: May 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Neuralgia
• Neuropathic Pain
• Spinal Disease
• Spinal Diseases
• Spinal Stenosis

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Priorov National Medical Research Center of Traumatology and Orthopedics	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
N.N. Priorov National Medical Research Center of Traumatology and Orthopedics

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	the safety parameters	To observe and document the safety parameters (Adverse events)	during study, an average of 1 year