Clinical trial NCT06407167: Neuropathic Pain in Patients With Degenerative Lumbar Stenosis
Official title: Observational Cohort Study of the Neuropathic Pain in Surgical Treatment of Patients With Degenerative Lumbar Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lumbar Spinal Stenosis
Neuropathic Pain
Spinal Disease
Lead sponsor: N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline in Oswestry Disability Index (ODI)
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Change from baseline in Neuropathic Pain 4 Questions (DN4)
timeFrame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
measure: Change from baseline in Numeric Pain Rating Scale (NPRS)
timeFrame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
measure: Change from baseline in Oswestry Disability Index (ODI)
timeFrame: 12 months postoperatively
measure: Change from baseline in The Health Transition Item from SF-36 (HTI Item)
timeFrame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
measure: Change from baseline in sagittal balance parameters
timeFrame: 3 months, 12 months postoperatively
measure: Change from baseline in regional balance parameters
timeFrame: 3 months, 12 months postoperatively
measure: Change from baseline in frontal balance parameters
timeFrame: 3 months, 12 months postoperatively
measure: the safety parameters
timeFrame: during study, an average of 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Priorov National Medical Research Center of Traumatology and Orthopedics
Study officials:
References: