Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis

• Status: Withdrawn
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose is to investigate the effect of Botox on the treatment of congenital muscular torticollis (CMT). The investigators' hypothesis is that a Botox injection will be an effective treatment when used in conjunction with current treatment procedures.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Infants diagnosed with CMT and referred by family physician, pediatrician or orthopaedic surgeon

• Initial assessment and initiation of treatment prior to 4 months of age

• Cervical spine radiograph, no focal bony abnormality

• Head tilt greater than 5 degrees at 5 months of age

• Lateral head righting past neutral in upright suspension

• Restricted neck range of movement in lateral flexion or rotation or both

• Signed consent form and willingness to participate in the study

• Compliance with attending bi-weekly follow-up appointments

Exclusion Criteria:

• Any other diagnosis affecting tone or muscle function

• Any condition that would preclude an anesthetic

• Any vertebral abnormalities identified by radiograph

• Attending other health practitioners for treatment, i.e., massage therapist, chiropractor

• Any associated ocular problems as determined by a pediatric ophthalmologist