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

Phase 1

Withdrawn

• Conditions: Torticollis

• Registration Number: NCT00175604
• Lead Sponsor: University of British Columbia

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 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 Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2011-02
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 the study
• Compliance with attending bi-weekly follow-up appointments

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome will be range of motion.	assessed bi-weekly until treatment is complete

Secondary Outcome Measures

Name	Time	Method
The secondary outcomes will be length of treatment time and number of required surgeries.	assessed bi-weekly until treatment is complete

Trial Locations

Locations (1)

British Columbia Children's Hospital, Dept. of Orthopedics; 🇨🇦 Vancouver, British Columbia, Canada