Clinical Trial: Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Comparative Trial of Botox Versus Conventional Treatment Used in the Management of Children With Congenital Muscular Torticollis (CMT)

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 treatment when used in conjunction with current treatment procedures.

Detailed Summary: 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.
Sponsor: University of British Columbia

Current Primary Outcome: The primary outcome will be range of motion. [ Time Frame: assessed bi-weekly until treatment is complete ]

Original Primary Outcome: The primary outcome will be range of motion assessed bi-weekly until treatment is complete.

Current Secondary Outcome: The secondary outcomes will be length of treatment time and number of required surgeries. [ Time Frame: assessed bi-weekly until treatment is complete ]

Original Secondary Outcome: The secondary outcomes will be length of treatment time and number of required surgeries assessed bi-weekly until treatment is complete.

Information By: University of British Columbia

Dates:
Date Received: September 13, 2005
Date Started: August 2004
Date Completion: February 2008
Last Updated: May 5, 2015
Last Verified: February 2011