Comparative Trial of Botox Versus Conventional Treatment Used in the Management of Children With Congenital Muscular Torticollis (CMT)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The primary outcome will be range of motion.
研究概览
简要总结
The primary purpose is to investigate the effect of Botox on the treatment of congenital muscular torticollis (CMT). The investigators' hypothesis is that a Botox injection will be an effective treatment when used in conjunction with current treatment procedures.
详细描述
The babies that require a neck collar for CMT will be randomly placed into two groups. One group will receive standard treatment which includes physiotherapy and occupational therapy. The other group will receive standard treatment plus an injection of Botox. The babies will be monitored to determine if one group has a more favorable outcome than the other in terms of range of motion, length of treatment time and number of required surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants diagnosed with CMT and referred by family physician, pediatrician or orthopaedic surgeon
- •Initial assessment and initiation of treatment prior to 4 months of age
- •Cervical spine radiograph, no focal bony abnormality
- •Head tilt greater than 5 degrees at 5 months of age
- •Lateral head righting past neutral in upright suspension
- •Restricted neck range of movement in lateral flexion or rotation or both
- •Signed consent form and willingness to participate in the study
- •Compliance with attending bi-weekly follow-up appointments
排除标准
- •Any other diagnosis affecting tone or muscle function
- •Any condition that would preclude an anesthetic
- •Any vertebral abnormalities identified by radiograph
- •Attending other health practitioners for treatment, i.e., massage therapist, chiropractor
- •Any associated ocular problems as determined by a pediatric ophthalmologist
结局指标
主要结局
The primary outcome will be range of motion.
时间窗: assessed bi-weekly until treatment is complete
次要结局
- The secondary outcomes will be length of treatment time and number of required surgeries.(assessed bi-weekly until treatment is complete)