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

Torticollis Clinical Trial

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

Status Withdrawn

Clinical Trial 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 Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Torticollis

• NCT number: NCT00175604
• Study type: Interventional
• Source: University of British Columbia
• Status: Withdrawn
• Phase: Phase 1
• Start date: August 2004
• Completion date: February 2008