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.
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.
Study Type
OBSERVATIONAL
Enrollment
120
DN4 includes a series of ten questions consisting of both sensory descriptors and signs related to bedside sensory examination
Priorov National Medical Research Center of Traumatology and Orthopedics
Moscow, Russia
Change from baseline in Oswestry Disability Index (ODI)
To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms
Time frame: 3 months postoperatively
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
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
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
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
Change from baseline in Oswestry Disability Index (ODI)
To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms
Time frame: 12 months postoperatively
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
Time frame: 2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively
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
Time frame: 3 months, 12 months postoperatively
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
Time frame: 3 months, 12 months postoperatively
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
Time frame: 3 months, 12 months postoperatively
the safety parameters
To observe and document the safety parameters (Adverse events)
Time frame: during study, an average of 1 year
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