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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Torticollis

Intervention / Treatment
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* Drug: Botox


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botox, torticollis, Congenital Muscular Torticollis (CMT)