Status:
WITHDRAWN
Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis
Lead Sponsor:
University of British Columbia
Conditions:
Torticollis
Eligibility:
All Genders
4-1 years
Phase:
PHASE1
Brief 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 treatm...
Detailed Description
The babies that require a neck collar for CMT will be randomly placed into two groups. One group will receive standard treatment which includes physiotherapy and occupational therapy. The other group ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00175604
Start Date
August 1 2004
End Date
February 1 2008
Last Update
May 6 2015
Active Locations (1)
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1
British Columbia Children's Hospital, Dept. of Orthopedics
Vancouver, British Columbia, Canada, V6H 3V4