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

May 5, 2015 updated by: University of British Columbia

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • British Columbia Children's Hospital, Dept. of Orthopedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome will be range of motion.
Time Frame: assessed bi-weekly until treatment is complete
assessed bi-weekly until treatment is complete

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary outcomes will be length of treatment time and number of required surgeries.
Time Frame: assessed bi-weekly until treatment is complete
assessed bi-weekly until treatment is complete

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Stephen Tredwell, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Anticipated)

February 1, 2008

Study Completion (Anticipated)

February 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C03-0550
  • W03-0164

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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