Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis
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ClinicalTrials.gov Identifier: NCT00175604
Recruitment Status :
(Not able to recruit any subjects for the study and was closed in February 2008)
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.
Condition or disease
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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
4 Months to 1 Year (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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