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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00175604
• Other study ID #: C03-0550
• Secondary ID: W03-0164
• Status: Withdrawn
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: May 5, 2015
• Start date: August 2004
• Est. completion date: February 2008

Study information

• Verified date: February 2011
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Months to 1 Year

Eligibility

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

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

Related Conditions & MeSH terms

• Torticollis

Intervention

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.

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital, Dept. of Orthopedics	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be range of motion.		assessed bi-weekly until treatment is complete	No
Secondary	The secondary outcomes will be length of treatment time and number of required surgeries.		assessed bi-weekly until treatment is complete	No