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

NCT00175604 | Withdrawn Phase 1

• 2 other identifiers: C03-0550W03-0164
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Torticollis

Keywords

Botox; torticollis; Congenital Muscular Torticollis (CMT)

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be range of motion.

  assessed bi-weekly until treatment is complete

Secondary Outcomes (1)

• The secondary outcomes will be length of treatment time and number of required surgeries.

  assessed bi-weekly until treatment is complete

Interventions

Botox DRUG

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.

Eligibility Criteria

• Age: 4 Months - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

British Columbia Children's Hospital, Dept. of Orthopedics

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Torticollis; Congenital torticollis

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Stephen Tredwell, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: August 1, 2004
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 6, 2015

Record last verified: 2011-02

Locations

CA (1)