Botox Clinical Trial

Summary

The surgery to correct leg \& foot deformities in children is a lengthy, \& sometimes, difficult procedure. Metal frames are attached to the leg and / or foot and over a period of time the frame is manipulated to obtain the corrected position. During this period the muscles \& skin become very tight which causes pain \& may pull the joint out of position. When this happens it is sometimes necessary to stop the treatment before the best position is obtained. This means that not only is the child left with an inadequate result but that further surgery is required in the future. If the tension could be removed whilst the treatment is underway this would reduce the pain, the possibility of joint damage \& potentially allow a more satisfactory to be obtained without the need for further surgery. Botulinum toxin or Botox, as it is commonly called, has the potential to temporarily reduce the tension in the muscles without causing permanent damage.

Timeline

Start

2008-03

Primary completion

2010-03

Completion

2010-05

Outcome

Outcome not reported

Stopped: “A similar study had already been conducted, therefore pursuing this trial would have been unethical”

Drugs

Indications

No indication recorded.