Prevalence of Neuropathic Pain After Non-instrumented Lumbar Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Comparison of the proportion of patients with neuropathic pain between the day before surgery and 12 months after surgery.
研究概览
简要总结
Chronic neuropathic pain following lumbar spine surgery is often under-diagnosed and difficult to relieve. It can persist long after the operation, sometimes for months or even years, and has a major impact on the quality of life of patients who suffer from it. However, the scientific literature on the subject remains relatively poor, as evidenced by the absence of scientific studies on the prevalence of neuropathic pain after lumbar spinal surgery, whether instrumented or not.
The main aim of this study is to determine whether lumbar spine surgery has an impact on the prevalence of neuropathic pain. Participants will be followed up and complete a quality-of-life questionnaire for one year after surgery.
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
- •Patients admitted for scheduled primary lumbar spine surgery without pedicle osteosynthesis or interbody cage.
- •Pathology concerned by programmed surgery: herniated disc or lumbar spinal stenosis, uncomplicated by motor or sphincter deficits.
- •Delay between 1st painful symptoms and surgery > 48h.
- •Non-inclusion criteria:
- •Surgery scheduled within 48 hours of onset of symptoms.
- •Presence of cauda equina syndrome
- •Presence of motor-radicular deficit
- •Patients with neurological pathology prior to surgery
- •Major cognitive or sensory disorders preventing completion of the self-questionnaire
- •Patients under guardianship
- •Patients not covered by French social security.
- •Patients who develop an identified neurological pathology after surgery, regardless of the initial surgery (e.g. multiple sclerosis, spinal cord injury, etc.).
排除标准
- 未提供
结局指标
主要结局
Comparison of the proportion of patients with neuropathic pain between the day before surgery and 12 months after surgery.
时间窗: The day before surgery and 12 months after surgery
Comparison of the proportion of patients with a score ≥ 4 measured with the DN4 questionnaire one day before surgery and 12 months after surgery. The DN4 questionnaire (4-question neuropathic pain scale) is a diagnostic tool used to identify and assess neuropathic pain. The questionnaire aims to measure the presence of symptoms and signs commonly associated with neuropathic pain. The questionnaire comprises 10 items: * 7 items relate to the patient's description of his or her pain (burning, painful cold, electric shocks, tingling, numbness, itching). * 3 items are based on the clinician's sensory examination, focusing on touch and pinprick hypoesthesia, as well as brush-induced allodynia. The DN4 is scored out of 10 points. A score of 4 or more suggests the presence of neuropathic pain.
次要结局
- Evolution of post-operative neuropathic pain(At 1, 3 and 6 months after surgery)
- Evolution of overall pain(The day before surgery and at 1, 3, 6 and 12 months after surgery)
- Evolution of functionality and disability of patients(The day before surgery and at 1, 3, 6 and 12 months after surgery)
- Evolution of quality of life measured with EQ-5D-5L(The day before surgery and at 1, 3, 6 and 12 months after surgery)