Posterior Cervical Fixation Versus Long-term Cervical Collar for Management of Hirayama Disease: Prospective Randomized Open Blinded Endpoint (PROBE), Phase III Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Odom's criteria score at six months
研究概览
简要总结
The goal of this clinical trial] is to compare cervical collar versus neck stabilization surgery in diagnosed patients of Hirayama disease who have been reporting worsening of problems in the past six months. The main question[s] it aims to answer are:
• Is cervical stabilization surgery (Posterior cervical fixation) superior to conservative management in the form of cervical collar placement in patients with progressive Hirayama disease, observed at six months after intervention
Participants will have equal chance to:
- Undergo cervical fixation surgery
- Cervical collar management The investigators will study and compare the efficacy of both treatments upto six months after intervention
详细描述
- Study design:
Prospective randomized open blinded endpoint (PROBE), phase III study 2. Inclusion criteria:
All the following:
-
Age ≥ 18 years
-
Patients with Hirayama disease as per the following criteria (All of the following) (16):
-
Clinical evidence of wasting and weakness confined to one limb (EMG evidence of denervation in the opposite limb will not be a reason for exclusion)
-
Progressive course, or initial progression followed by stationary course; and
-
No evidence of a compressive lesion of the spinal cord.
-
Disease duration of ≤4 years
-
Progression of clinical symptoms in the past six-months c. Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the following:
- •Age ≥ 18 years
- •Patients with Hirayama disease as per the following criteria (All of the following) (16):
- •Clinical evidence of wasting and weakness confined to one limb (EMG evidence of denervation in the opposite limb will not be a reason for exclusion)
- •Progressive course, or initial progression followed by stationary course; and
- •No evidence of a compressive lesion of the spinal cord.
- •Disease duration of ≤4 years
- •Progression of clinical symptoms in the past six-months
排除标准
- •Any of the following:
- •Refusal to consent for randomization
- •Not willing to come for three- and six-months follow-up
结局指标
主要结局
Odom's criteria score at six months
时间窗: Six months after intervention
次要结局
- interval change in DTI metrics of fractional anisotropy (FA) and apparent diffusion coefficient (ADC) of cervical cord(at six-months post-intervention)
- Odom's criteria score at three months(Three months after intervention)
- Electrophysiological and grip strength(6 month)
研究者
Deepti Vibha
Professor, Neurology
All India Institute of Medical Sciences, New Delhi