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NCT Number: NCT03198702

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

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.

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Key information

Conditions

Obstetrical Brachial Plexus Palsy Birth Injuries Brachial Plexus Neuropathies Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Neonatal Brachial Plexus Palsy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Wounds and Injuries

Age range

10 month–11 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHRU Brest, Brest, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A injection

Drug

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.

SHAM

Other

The injection is mimed, the procedure is the same as the botulinum toxin injection.

Primary outcomes

  1. 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 outcomes

  1. 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

    With 2D glenoid changes measured on axial MRI and 3D glenoid version and migration of the humeral head measured on MRI

  2. 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

    By measurement of passive range of motion, Active Movement Scale and Assistive Hand Assessment.

  3. confirm good clinical tolerance of BTI treatment

    Time frame: At 18 month age

    By measurement of the number of serious and non-serious adverse events

  4. 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

    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)

  5. 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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sylvain Brochard, Pr

CONTACT

[email protected]

(+33) 02 98 22.33.73

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: POPB-TOX

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2017
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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