NCT02060734撤回4 期
Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated disorder-a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- pain
研究概览
简要总结
To determine the efficacy of lidocaine injection of trigger points versus subcutaneous injection in patients with subacute whiplash associated disorder following injury.
详细描述
This is a double-blind, randomized controlled trial to determine the efficacy of lidocaine injection of trigger points versus subcutaneous injection in patients with subacute whiplash associated disorder following injury. Outcomes include pain, objective assessment, self-report function recovery, impact on work performance and globe perceived effects which will be assessed 5 minutes, 2 and 6 weeks following injection.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fulfill the Grade II Quebec Task Force classification of WAD,
- •with identifiable myofascial trigger points ( which occur with or without a taut band),
- •reproduction of recognizable pain with sustained pressure ( up to 10 seconds) on trigger points
- •aged 18 to 70
- •a good understanding of informed consent and willing to attend this trial.
排除标准
- •have serious injury such as fracture and internal bleeding
- •suspicion of upper cervical instability or neurological deficits
- •clinical evidence of radiculopathy
- •a history of active cancer, central nerve disorder, blood clotting disorders, needle phobia
- •anticoagulant medication user
- •previous experience with any type of needling for myofascial pain
结局指标
主要结局
pain
时间窗: 2 weeks following injection
10 cm Visual Analog Scale
次要结局
- work performance(Immediately, 2 and 6 weeks after injection)
- pain(6 weeks following injection)
- globe perceived effects(Immediately, 2 and 6 weeks after injection)
- cervical range of motion(Immediately, 2 and 6 weeks after injection)
- self-report neck disability(Immediately, 2 and 6 weeks after injection)
研究者
Maggie Qiyun Shi
Graduate student, Western University
Hamilton Health Sciences Corporation
研究点 (4)
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