Botox Clinical Trial
Information source: Sheffield Children's NHS Foundation Trust
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leg Length Inequality; Foot Deformities
Intervention: Botox (Drug); Saline (Other)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Sheffield Children's NHS Foundation Trust Official(s) and/or principal investigator(s):
Maria Burton, Principal Investigator, Affiliation: Sheffield Children's Hospital
Overall contact:
James A Fernandes, Phone: 0114 2717000, Email: james.fernandes@sch.nhs.uk
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.
Clinical Details
Official title: Botulinum Toxin: an Adjunct in Limb Reconstruction - Can it Reduce Pain and Joint Complications in the Lengthening Phase?
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Primary outcome: The pain levels using a visual analogue scale validated at the Sheffield Children's Hospital
Secondary outcome: Range of movement in affected joints measured by a goniometre
Detailed description:
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).
Online Form 6 Some groups of children who undergo lengthening are more susceptible to soft
tissue tension than others and therefore prophylactic surgical measures are employed. In
anticipation of the soft tissue tension muscles known to create problems are commonly
selected for surgical releases. This has been shown to be an effective method for reducing
the effects of the tension but it is not without its problems. Releases done at the time of
surgery may heal before the lengthening is complete and may need to be repeated. Releases
cause trauma to the muscle or tendon which then heals by scar tissue, a structure known to be
less pliable than specialised muscle or tendon tissue. Regaining long term function can be
compromised.
Temporarily reducing soft tissue tension during the lengthening phase of treatment which has
no long term consequences would be an ideal situation. Botulinum toxin has the ability to do
this. Paley (2004) used Botulinum toxin as an adjunct to or in place of soft tissue release
during femoral lengthening and noted that it seemed to reduce muscle spasm and pain in
patients. Unfortunately this was not supported by any form of evaluative research.
Eligibility
Minimum age: 6 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Any child with femoral, tibial deformity or CTEV having limb reconstruction surgery
which involves the distraction of bone and or soft tissue.
Exclusion Criteria:
- Children with neurological aetiology
Locations and Contacts
James A Fernandes, Phone: 0114 2717000, Email: james.fernandes@sch.nhs.uk
Clinical Research Facility, Sheffield Children's Hospital, Sheffield, South Yorkshire S10 2TH, United Kingdom
Additional Information
Starting date: March 2008
Ending date: May 2010
Last updated: February 25, 2008
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