NCT00175604

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

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 4 Months – 1 Year
• Healthy volunteers: Not accepted

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 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.

Conditions

• Torticollis

Interventions

Type	Name	Description
DRUG	Botox	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.

Timeline

• Start date: 2004-08-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2005-09-15
• Last updated: 2015-05-06

Locations

1 site across 1 country: Canada