Botulinum Toxin: an Adjunct in Limb Reconstruction - Can it Reduce Pain and Joint Complications in the Lengthening Phase?
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The pain levels using a visual analogue scale validated at the Sheffield Children's Hospital
研究概览
简要总结
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.
详细描述
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 is to slow or stop the lengthening for a few days which allows the soft tissue tension to decrease. The drawback with this is the potential for the bone ends to start fusing and prevent further lengthening once the process is resumed. To re start the process means the child has to have a further general anaesthetic to enable the bone to be re osteotomised (re broken).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any child with femoral, tibial deformity or CTEV having limb reconstruction surgery which involves the distraction of bone and or soft tissue.
排除标准
- •Children with neurological aetiology
研究组 & 干预措施
Botox
Botox
干预措施: Botox (Drug)
Placebo
Saline injection
干预措施: Saline (Other)
结局指标
主要结局
The pain levels using a visual analogue scale validated at the Sheffield Children's Hospital
时间窗: 2 years
次要结局
- Range of movement in affected joints measured by a goniometre(2 years)