Clinical Trial: Botox Clinical Trial
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Botulinum Toxin: an Adjunct in Limb Reconstruction - Can it Reduce Pain and Joint Complications in the Lengthening Phase?
Brief 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.
Detailed Summary:
Excessive soft tissue tension (i.e.. tight muscles and associated tissues) is the most limiting factor in lengthening and correction of limb length deficiency. Bone lengthening is achieved by surgically breaking the bone and with the use of an extending device, commonly placed on the outside of the limb, the bones ends are distracted. One millimetre a day is commonly the amount of distraction, however the soft tissue increases in length at a slower pace than the bone which leads to soft tissue tension.
Excessive soft tissue tension leads to:
- Soft tissue contractures temporary or permanent short muscles and tendons
- Joint subluxation or instability joints which slip out of line and are loose
- Pain
- Loss of function inability to move joints properly and difficulty walking This puts the joint in a very vulnerable situation and increases the possibility of subluxation. A similar problem arises during tibial lengthening, when the ankle takes up an equinus position (foot pointing down and in). Both deformities reduce the functional ability of the child and risk the joint becoming permanently damaged.
Increasing pain levels accompany these deformities leading to a greater reluctance to comply with treatment or rehabilitation. The lack of joint mobility has further detrimental effect on the limb as it becomes weak and stiff.
These events become a vicious cycle which is difficult to resolve without further intervention. When soft tissue tension is becoming a problem, i.e. pain levels are increasing and difficult to control, or the joint is under threat of instability, the first course of action
Sponsor: Sheffield Children's NHS Foundation Trust
Current Primary Outcome: The pain levels using a visual analogue scale validated at the Sheffield Children's Hospital [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Range of movement in affected joints measured by a goniometre [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Sheffield Children's NHS Foundation Trust
Dates:
Date Received: February 15, 2008
Date Started: March 2008
Date Completion: May 2010
Last Updated: March 17, 2015
Last Verified: March 2015
