Back to resultsComparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis
Primary Purpose
Torticollis
Status
Withdrawn
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Botox
Sponsored by
About this trial
This is an interventional treatment trial for Torticollis focused on measuring Botox, torticollis, Congenital Muscular Torticollis (CMT)
Eligibility Criteria
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
Sites / Locations
- British Columbia Children's Hospital, Dept. of Orthopedics
Outcomes
Primary Outcome Measures
The primary outcome will be range of motion.
Secondary Outcome Measures
The secondary outcomes will be length of treatment time and number of required surgeries.
Full Information
NCT ID
NCT00175604
First Posted
September 13, 2005
Last Updated
May 5, 2015
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00175604
Brief Title
Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis
Official Title
Comparative Trial of Botox Versus Conventional Treatment Used in the Management of Children With Congenital Muscular Torticollis (CMT)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Not able to recruit any subjects for the study and was closed in February 2008
Study Start Date
August 2004 (undefined)
Primary Completion Date
February 2008 (Anticipated)
Study Completion Date
February 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Torticollis
Keywords
Botox, torticollis, Congenital Muscular Torticollis (CMT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Botox
Intervention 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.
Primary Outcome Measure Information:
Title
The primary outcome will be range of motion.
Time Frame
assessed bi-weekly until treatment is complete
Secondary Outcome Measure Information:
Title
The secondary outcomes will be length of treatment time and number of required surgeries.
Time Frame
assessed bi-weekly until treatment is complete
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Tredwell, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Children's Hospital, Dept. of Orthopedics
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis
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