Predictors of Outcome and Natural History in Patients With Cervical Spondylotic Myelopathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Japanese Orthopaedic Association scale
研究概览
简要总结
Cervical spondylotic myelopathy (CSM) is the most frequent cause of myelopathy in those over the age of 50. They claim that surgical treatment of myelopathy, especially of the mild and moderate forms, has not shown better results than conservative treatment in the long term, and criteria for the indication and the timing of the operation have not been established. In order to get some more reliable data, a long-term follow up observational study will be started to confirm the effects of long term for conservative treatment.
详细描述
Cervical spondylotic myelopathy (CSM) is the most frequent cause of myelopathy in those over the age of 50 [1]. It is believed to have a generally progressive course over a period of years, with sudden acceleration especially following a slight head and neck injury, leading to significant disability [2, 3]. The treatment of CSM remains a problem, particularly in the mild and moderate forms without rapid progression.
Excellent outcomes for surgery have been presented in many studies. All of the studies, however, are retrospective, and many lack a clear design, standard criteria, control groups, and sufficient follow-up, so it is difficult to compare [4, 5, 6]. Furthermore, several studies and critical reviews are not so optimistic. They claim that surgical treatment of myelopathy, especially of the mild and moderate forms, has not shown better results than conservative treatment in the long term, and criteria for the indication and the timing of the operation have not been established [7, 8, 9]. Twenty-five percent of patients with laminoplasty suffer from severe neck and shoulder pain for more than 3 months [10], with significant morbidity from the iliac crest donor site etc. Surgery to decompress and stabilize the spine is often advocated for severe or progressive symptoms, with mixed results. About two-thirds of patients improve with surgery, whereas surgery is not successful in 15% to 30% of cases [11].
In order to get some more reliable data, a long-term follow up observational study will be started to confirm the effects of long term for conservative treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs and symptoms of cervical cord dysfunction
- •Magnetic resonance imaging (MRI) criteria for cervical multisegmental cord compression and/or myelopathy due to spondylosis (including soft disc herniations) with or without developmentally narrow spinal canal
- •Age under 75 years
- •Patient's consent to conservative treatment It has been suggested that magnetic resonance imaging
排除标准
- •Spinal cord compression, without clinical symptoms
- •Previous surgery on the cervical spine
- •Uncertainty about the presence of significant additional diseases (such as Motor neurone disease, progressive polyarthritis)
- •Cervical cord dysfunction due to tumors, trauma, soft disc herniation or previous surgery
- •Serious that require a surgical procedure
结局指标
主要结局
Japanese Orthopaedic Association scale
时间窗: 3 years
Japanese Orthopaedic Association scale assessed for 3 years
次要结局
- Adverse Event(6 months, 1, 2, 3,4 and 5 years)
- Visual Analogue Scale(6 months, 1, 2, 3,4 and 5 years)
- Neck Disability Index(6 months, 1, 2, 3,4 and 5 years)
- the Medical Outcomes Study short form health survey-36(6 months, 1, 2, 3,4 and 5 years)
- Japanese Orthopaedic Association scale(6 months, 1, 2, 4 and 5 years)