Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Botulinum toxin type A injection, Sham.
- Who it may be relevant to
- Registry conditions: Obstetrical Brachial Plexus Palsy. Basic parameters: 10 months — 11 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Botulinum toxin type A injection
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. - Other Sham
The injection is mimed, the procedure is the same as the botulinum toxin injection.
Primary outcome measures
- 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). [Time frame: At 18 month age]
Secondary outcome measures (5)
- compare the effectiveness of BTI with Sham procedure in preventing an increase in glenoid retroversion and three-dimensional deformity [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 [Time frame: At 18 month age]
- confirm good clinical tolerance of BTI treatment [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 [Time frame: At 18 month age]
- determine if the treatment changes the frequency and type of surgical interventions in the long term [Time frame: every years on 2 years old to 10 years old]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 7 centers
- CHRU Brest — Brest
- Institut Régionnal de Réadaptation Centre de Réadaptation pour enfant — Flavigny-sur-Moselle
- ESEAN (Etablissement de Santé pour Enfants et Adolescents de la région Nantaise) — Nantes
- CHU Nîmes — Nîmes
- CHU Rennes — Rennes
- CHU St Etienne — Saint-Etienne
- Hôpital national de saint maurice — Saint-Maurice
Publications
- Pons C, Eddi D, Le Gal G, Garetier M, Ben Salem D, Houx L, Fitoussi F, Quintero N, Brochard S; POPB-TOX Group. Effectiveness and safety of early intramuscular botulinum toxin injections to prevent shoulder deformity in babies with brachial plexus birth injury (POPB-TOX), a randomised controlled trial: study protocol. BMJ Open. 2019 Sep 30;9(9):e032901. doi: 10.1136/bmjopen-2019-032901. PMID 31575585
Identifiers
NCT: NCT03198702 · POPB-TOX RB15.050