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

This study has been withdrawn prior to enrollment.
(Not able to recruit any subjects for the study and was closed in February 2008)
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175604
First received: September 13, 2005
Last updated: February 18, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Torticollis
Drug: Botox
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Trial of Botox Versus Conventional Treatment Used in the Management of Children With Congenital Muscular Torticollis (CMT)

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • The primary outcome will be range of motion. [ Time Frame: assessed bi-weekly until treatment is complete ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcomes will be length of treatment time and number of required surgeries. [ Time Frame: assessed bi-weekly until treatment is complete ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2004
Estimated Study Completion Date: February 2008
Estimated Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   4 Months to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175604

Locations
Canada, British Columbia
British Columbia Children's Hospital, Dept. of Orthopedics
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Stephen Tredwell, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Stephen Tredwell, University of British Columbia
ClinicalTrials.gov Identifier: NCT00175604     History of Changes
Other Study ID Numbers: C03-0550, W03-0164
Study First Received: September 13, 2005
Last Updated: February 18, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Botox
torticollis
Congenital Muscular Torticollis (CMT)

Additional relevant MeSH terms:
Torticollis
Dystonic Disorders
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Dystonia
Dyskinesias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014