Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
Study NCT ID:
NCT06407167
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-20
First Post:
2024-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuropathic Pain in Patients With Degenerative Lumbar Stenosis
Sponsor:
N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
Organization:
Study Overview
Official Title:
Observational Cohort Study of the Neuropathic Pain in Surgical Treatment of Patients With Degenerative Lumbar Stenosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: