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

Regional University Hospital Center (CHRU)

Status and phase: Enrolling; Phase 3

Conditions: Obstetrical Brachial Plexus Palsy

Treatments: Other: Sham; Drug: Botulinum toxin type A injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03198702

POPB-TOX RB15.050

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 10 to 11 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

62 participants in 2 patient groups

Toxin group

Experimental group

Description:

The babies receive a botulinum toxin type A injection at the age of 12 months

Treatment:

Drug: Botulinum toxin type A injection

Sham group

Sham Comparator group

Description:

The babies receive a simulated injection procedure at the age of 12 months

Treatment:

Other: Sham