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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
62
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.
The injection is mimed, the procedure is the same as the botulinum toxin injection.
CHRU Brest
Brest, France
RECRUITINGInstitut Régionnal de Réadaptation Centre de Réadaptation pour enfant
Flavigny-sur-Moselle, France
NOT_YET_RECRUITINGESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise)
Nantes, France
NOT_YET_RECRUITINGCHU Nîmes
Nîmes, France
RECRUITINGCHU Rennes
Rennes, France
RECRUITINGCHU St Etienne
Saint-Etienne, France
NOT_YET_RECRUITINGHôpital national de saint maurice
Saint-Maurice, France
RECRUITINGChange 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).
Time frame: At 18 month age
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
Time frame: 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.
Time frame: At 18 month age
confirm good clinical tolerance of BTI treatment
By measurement of the number of serious and non-serious adverse events
Time frame: 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)
Time frame: 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).
Time frame: every years on 2 years old to 10 years old
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