Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy

Conditions
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Obstetrical Brachial Plexus Palsy

Intervention / Treatment
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* Drug: Botulinum toxin type A injection
* Other: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 10 Months
Maximum Age: 11 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: First group or toxin group: the babies will receive BOTOX injections at the age of 12 months in the shoulder muscles. Second group or sham group:the babies receive the same procedure but no injection.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toxin group<br>The babies receive a botulinum toxin type A injection at the age of 12 months | Drug: Botulinum toxin type A injection<br>* A total of 8UI/kg will be injected in the internal shoulder rotator muscles: 2UI/kg in the sub scapular muscle, 3UI/kg in the pectoralis major muscle and 3UI/kg in the teres major/latissimus dorsi muscle.<br>|
| Sham Comparator: Sham group<br>The babies receive a simulated injection procedure at the age of 12 months | Other: Sham<br>* The injection is mimed, the procedure is the same as the botulinum toxin injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | At 18 month age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare the effectiveness of BTI with Sham procedure in preventing an increase in glenoid retroversion and three-dimensional deformity | With 2D glenoid changes measured on axial MRI and 3D glenoid version and migration of the humeral head measured on MRI | At 18 month age | 
| compare the effectiveness of BTI with Sham procedure in the improvement of active and passive joint range of motion and upper limb function | By measurement of passive range of motion, Active Movement Scale and Assistive Hand Assessment. | At 18 month age | 
| confirm good clinical tolerance of BTI treatment | By measurement of the number of serious and non-serious adverse events | 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 | Bu measurement of the degree of trophicity, fibrosis and fatty infiltration of the injected muscles (supraspinous, infraspinous, teres minor, subscapularis, teres major, pectoralis major, deltoid and latissimus dorsi) | At 18 month age | 
| determine if the treatment changes the frequency and type of surgical interventions in the long term | the number and type of surgical interventions undergone by the children in each group will be recorded during routine medical follow-up (as in usual practice) until the child's 10th birthday following unblinding (9 years and 6 months after the BTI). | every years on 2 years old to 10 years old | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder deformation, obstetrical brachial plexus palsy, physiotherapy, children