The primary purpose is to investigate the effect of Botox on the treatment of CMT. Our hypothesis is that Botox injection will be an effect treatment when used in conjunction with current treatment procedures.

Condition	Intervention	Phase
Congenital Muscular Torticollis (CMT)	Drug: Botox	Phase I

Further Study Details: 

Primary Outcomes: The primary outcome will be range of motion assessed bi-weekly until treatment is complete.
Secondary Outcomes: The secondary outcomes will be length of treatment time and number of required surgeries assessed bi-weekly until treatment is complete.
Expected Total Enrollment:  20

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.

Ages Eligible for Study:  4 Months   -   1 Year,  Genders Eligible for Study:  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 study; compliance with attending biweekly follow-up appointments.

Exclusion Criteria:

a ny 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00175604

Angie Perdios      604-875-2359    aperdios@cw.bc.ca

Canada, British Columbia
      British Columbia Children’s Hospital, Dept. of Orthopedics, Vancouver,  British Columbia,  V6H 3V4,  Canada

Study chairs or principal investigators

Stephen Tredwell, MD,  Principal Investigator,  University of British Columbia   

Study ID Numbers:  C03-0550; W03-0164
Last Updated:  September 14, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00175604
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-20