Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis
Information source: University of British Columbia
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Torticollis
Intervention: Botox (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s):
Stephen Tredwell, MD, Principal Investigator, Affiliation: University of British Columbia
Overall contact:
Angie Perdios, Phone: 604-875-2359, Email: aperdios@cw.bc.ca
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.
Clinical Details
Official title: Comparative Trial of Botox Versus Conventional Treatment Used in the Management of Children With Congenital Muscular Torticollis (CMT)
Study design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary outcome will be range of motion.
Secondary outcome: The secondary outcomes will be length of treatment time and number of required surgeries.
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 will receive standard treatment plus an injection of Botox. The babies will
be monitored to determine if one group has a more favorable outcome than the other in terms
of range of motion, length of treatment time and number of required surgeries.
Eligibility
Minimum age: 4 Months.
Maximum age: 1 Year.
Gender(s): Both.
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
Locations and Contacts
Angie Perdios, Phone: 604-875-2359, Email: aperdios@cw.bc.ca
British Columbia Children's Hospital, Dept. of Orthopedics, Vancouver, British Columbia V6H 3V4, Canada
Additional Information
Starting date: December 2008
Ending date: December 2010
Last updated: August 26, 2008
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