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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2008-02-29

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.

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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.

Conditions

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Torticollis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DRUG

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

Minimum Eligible Age

4 Months

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No