Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis (NCT00175604) | Clinical Trial Compass
WithdrawnPhase 1
Comparative Trial of Botox in the Management of Children With Congenital Muscular Torticollis
Stopped: Not able to recruit any subjects for the study and was closed in February 2008
Canada0Started 2004-08
Plain-language 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.
Who can participate
Age range
4 Months – 1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary outcome will be range of motion.
Timeframe: assessed bi-weekly until treatment is complete