Observational Cohort Study of the Neuropathic Pain in Surgical Treatment of Patients With Degenerative Lumbar Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change from baseline in Oswestry Disability Index (ODI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years;
- •Radicular leg pain with or without neurogenic claudication with or without back pain;
- •Planned decompressive surgery for degenerative lumbar stenosis with or without degenerative spondylolisthesis;
- •Symptoms persisting for at least 3 months prior to surgery;
- •Given written Informed Consent;
- •Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements
排除标准
- •Prior lumbar fusion at any level;
- •Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
- •Back or non-radicular pain of unknown etiology;
- •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);
- •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;
- •Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
结局指标
主要结局
Change from baseline in Oswestry Disability Index (ODI)
时间窗: 3 months postoperatively
To observe the change of Oswestry Disability Index as compared to baseline through follow-up terms
次要结局
- Change from baseline in sagittal balance parameters(3 months, 12 months postoperatively)
- Change from baseline in frontal balance parameters(3 months, 12 months postoperatively)
- Change from baseline in Oswestry Disability Index (ODI)(12 months postoperatively)
- Change from baseline in Neuropathic Pain 4 Questions (DN4)(2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively)
- Change from baseline in regional balance parameters(3 months, 12 months postoperatively)
- Change from baseline in Numeric Pain Rating Scale (NPRS)(2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively)
- Change from baseline in The Health Transition Item from SF-36 (HTI Item)(2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively)
- the safety parameters(during study, an average of 1 year)
研究者
Aleksandr Krutko
Head of Neurosurgery Department
N.N. Priorov National Medical Research Center of Traumatology and Orthopedics