Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 7
- 主要终点
- Change in the percentage posterior migration of the humeral head measured on axial MRI slices between 11 (before the BTI carried out at 12 months) and 18 months of age (6 months post BTI).
研究概览
简要总结
In children population with obstetrical brachial plexus palsy (OBPP), shoulder musculoskeletal deformity is the main cause of morbidity, with a loss of range of shoulder motion, pain and a reduction in social participation. Some uncontrolled studies shows that early injections of botulinum toxin (BTI) in the internal shoulder rotator muscles (which cause the deformity) are one of the most promising treatment for the prevention of bony deformity.
The main objective of this study will be the evaluation of the effectiveness of BTI in the internal shoulder rotator muscles at the age of 12 months in preventing an increase in posterior subluxation of the glenohumeral joint in babies with OBPP (evaluated at the ages of 11 months and 18 months), compared to the Sham group.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Months 至 11 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female babies with unilateral OBPP
- •Age between 10 and 11 months
- •Presenting one of 2 risk factors for posterior subluxation of the humeral head (10° less passive external ROM of the affected shoulder compared with the contralateral shoulder and/or a score strictly less than 6 on the AMS for shoulder external rotation and abduction, elbow flexion or supination)
- •Signature of the consent form by (the) parent(s) over the age of majority
排除标准
- •Bilateral OBPP
- •Microsurgery or secondary muscle surgery planned between 12 and 18 months of age
- •Contraindications to the use of botulinum toxin
- •Contraindications to MRI
- •MRI not possible in the Paediatric Day Hospital setting because of contraindications to the sedation protocol or due to organisational constraints
- •Parents inapt to provide consent for the participation of their child
- •Parents under the age of 18 years
研究组 & 干预措施
Toxin group
The babies receive a botulinum toxin type A injection at the age of 12 months
干预措施: Botulinum toxin type A injection (Drug)
Sham group
The babies receive a simulated injection procedure at the age of 12 months
干预措施: Sham (Other)
结局指标
主要结局
Change in the percentage posterior migration of the humeral head measured on axial MRI slices between 11 (before the BTI carried out at 12 months) and 18 months of age (6 months post BTI).
时间窗: At 18 month age
次要结局
- compare the effectiveness of BTI with Sham procedure in the improvement of active and passive joint range of motion and upper limb function(At 18 month age)
- confirm good clinical tolerance of BTI treatment(At 18 month age)
- evaluate the effects of BTI on trophicity, fibrosis and fatty infiltration of the injected muscles as well as muscle balance of the OBPP shoulder(At 18 month age)
- determine if the treatment changes the frequency and type of surgical interventions in the long term(every years on 2 years old to 10 years old)
- compare the effectiveness of BTI with Sham procedure in preventing an increase in glenoid retroversion and three-dimensional deformity(At 18 month age)