Botox Clinical Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Sheffield Children's NHS Foundation Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheffield Children's NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00624299
First received: February 15, 2008
Last updated: February 25, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Leg Length Inequality
Foot Deformities
Drug: Botox
Other: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Botulinum Toxin: an Adjunct in Limb Reconstruction - Can it Reduce Pain and Joint Complications in the Lengthening Phase?

Resource links provided by NLM:


Further study details as provided by Sheffield Children's NHS Foundation Trust:

Primary Outcome Measures:
  • The pain levels using a visual analogue scale validated at the Sheffield Children's Hospital [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Range of movement in affected joints measured by a goniometre [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: March 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botox
Botox
Drug: Botox
Botox injection (100 ius) per muscle
Placebo Comparator: Placebo
Saline injection
Other: Saline
Saline injection

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

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624299

Contacts
Contact: James A Fernandes 0114 2717000 james.fernandes@sch.nhs.uk
Contact: Maria Burton 0114 2717000 maria.burton@sch.nhs.uk

Locations
United Kingdom
Clinical Research Facility, Sheffield Children's Hospital Not yet recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2TH
Principal Investigator: James A Fernandes         
Sponsors and Collaborators
Sheffield Children's NHS Foundation Trust
Investigators
Principal Investigator: Maria Burton Sheffield Children's Hospital
  More Information

No publications provided

Responsible Party: Dr Jim Bonham, Sheffield Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00624299     History of Changes
Other Study ID Numbers: SCH-07-006
Study First Received: February 15, 2008
Last Updated: February 25, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sheffield Children's NHS Foundation Trust:
botox
limb reconstructions
limb reconstruction surgery

Additional relevant MeSH terms:
Leg Length Inequality
Congenital Abnormalities
Foot Deformities
Foot Deformities, Congenital
Musculoskeletal Diseases
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Bone Diseases, Developmental
Bone Diseases
Pathological Conditions, Anatomical
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014