Evaluation of the effects of botulinum toxin A injections in improving ease of care and increasing comfort in children with marked cerebral palsy: a randomised controlled trial.

The effects of botulinum toxin A injections on ease of care and comfort in children with marked cerebral palsy

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000360213

Enrollment

Registered

2009-05-26

Start date

2009-03-16

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Children with the more severe forms of cerebral palsy often have difficulties with pain or discomfort associated with spasticity. Spasticity can also impact upon the burden of care parents experience. Botulinum toxin A has been used for over a decade in the treatment of spasticity for children with cerebral palsy however most research to date has focussed on functional gains for children with the less severe forms of cerebral palsy. this study hypothesises that botulinum toxin A injections when combined with a therapy program improves outcomes of burden of care and comfort for children with severe cerebral palsy when compared to a therapy program alone.

Interventions

Botulinum toxin A injections to clinically selected muscles, occupational therapy, physiotherapy. Dose: Total dose not to exceed 12 units per kg or 400 units total. Dosage per muscle group: Upper limb Intrinsic muscles hand: 1/2 unit per kg or maximum 20 units per muscle. Finger flexors: 1/2 - 1 unit per kg or maximum 30 units. Wrist flexors:1/2 - 1 unit per kg or maximum 30 units. Pronators: 1/2 - 1 unit per kg or maximum 30 units. Elbow flexors: 1-2 units per kg or maximum 60 units. Pectoral muscles, lattisimus dorsi, teres major: 1/2 - 2 units per kg or maximum 60 units per muscle group. Deltoid: 1 unit per kg or maximum 50 units. Lower limb Adductors: 2-4 units per kg maximum dose 80 units. Hamstrings: 2-4 units per kg with maximum dose 80 units. Quadriceps:2-4 units per kg maximum dose 80 units. Gastrocnemius: 2-4 units per kg maximum dose 100 units. Maximum dose 50 units per site. Any injection > 50 units requires more than one injection site. All injections are intramuscular with ultrasound and/or nerve stimulator guidance. Injections (or placebo) occur at baseline. Injections are repeated at 6 months. children will all receive physical therapy and occupational therapy following injections/ sham procedure for up to 6 weeks on a weekly basis. Therapy will include serial casting for maximum 2 weeks as required. Occupational therapy and or physiotherapy requirements are determined on patient goals by blinded therapist. Injections will be repeated at a 6 month interval. Analgesia for injections will be provided with intranasal fentanyl and topical anaesthetic.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

2 Years to 16 Years

Healthy volunteers

Inclusion criteria

Age 2-16 years, diagnosis of cerebral palsy classified GMFCS 4-5. Child/family have goals primarily concerned with improving care and/or comfort associated with spasticity affecting upper and/or lower limbs.

Exclusion criteria

Medical contraindications to botulinum toxin A. Any botulinum toxin A injections occurring within 6 months of the study, any upper limb or lower limb casting within 2 months of initiation of the study, changes to oral or other spasticity management agents occuring within 2 months.

Outcome results