Torticollis Clinical Trial
Official title:
Comparative Trial of Botox Versus Conventional Treatment Used in the Management of Children With Congenital Muscular Torticollis (CMT)
Verified date | February 2011 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Months to 1 Year |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | British Columbia Children's Hospital, Dept. of Orthopedics | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome will be range of motion. | assessed bi-weekly until treatment is complete | No | |
Secondary | The secondary outcomes will be length of treatment time and number of required surgeries. | assessed bi-weekly until treatment is complete | No |
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