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

Обзор

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.

Вмешательства

• Препарат 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.
• Другое Sham
  The injection is mimed, the procedure is the same as the botulinum toxin injection.

Первичные конечные точки

• 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). [Срок оценки: At 18 month age]

Вторичные конечные точки (5)

• compare the effectiveness of BTI with Sham procedure in preventing an increase in glenoid retroversion and three-dimensional deformity [Срок оценки: 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 [Срок оценки: At 18 month age]
• confirm good clinical tolerance of BTI treatment [Срок оценки: 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 [Срок оценки: At 18 month age]
• determine if the treatment changes the frequency and type of surgical interventions in the long term [Срок оценки: every years on 2 years old to 10 years old]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 7 центров

• 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

Публикации

• 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

Идентификаторы

NCT: NCT03198702 · POPB-TOX RB15.050

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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