Article
Botulinum neurotoxin serotype A: a clinical update on non-cosmetic uses.
Movement Disorders Clinic, Vanderbilt University, Nashville, TN, USA.
American Journal of Health-System Pharmacy (impact factor:
1.96).
12/2004;
61(22 Suppl 6):S11-23.
pp.S11-23
Source: PubMed
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Citations (0)
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Article: Safety and efficacy of botox injection in alleviating post-operative pain and improving quality of life in lower extremity limb lengthening and deformity correction.
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ABSTRACT: Distraction osteogenesis is the standard treatment for the management of lower limb length discrepancy of more than 3 cm and bone loss secondary to congenital anomalies, trauma or infection. This technique consists of an osteotomy of the bone to be lengthened, application of an external fixator, followed by gradual and controlled distraction of the bone ends. Although limb lengthening using the Ilizarov distraction osteogenesis principle yields excellent results in most cases, the technique has numerous problems and is not well tolerated by many children. The objective of the current study is to determine if Botulinum Toxin A (BTX-A), which is known to possess both analgesic and paralytic actions, can be used to alleviate post-operative pain and improve the functional outcome of children undergoing distraction osteogenesis. The study design consists of a multi centre, randomized, double-blinded, placebo-controlled trial. Patients between ages 5-21 years requiring limb lengthening or deformity correction using distraction will be recruited from 6 different sites (Shriners Hospital for Children in Montreal, Honolulu, Philadelphia and Portland as well as DuPont Hospital for Children in Wilmington, Delaware and Hospital for Sick Children in Toronto, Ont). Approximately 150 subjects will be recruited over 2 years and will be randomized to either receive 10 units per Kg of BTX-A or normal saline (control group) intraoperatively following the surgery. Functional outcome effects will be assessed using pain scores, medication dosages, range of motion, flexibility, strength, mobility function and quality of life of the patient. IRB approval was obtained from all sites and adverse reactions will be monitored vigorously and reported to IRB, FDA and Health Canada. BTX-A injection has been widely used world wide with no major side effects reported. However, to the best of our knowledge, this is the first time BTX-A is being used under the context of limb lengthening and deformity correction. NCT00412035.Trials 02/2007; 8:27. · 2.02 Impact Factor
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Keywords
botulinum toxin type
botulinum toxin type A
central nervous system
cerebral palsy
cervical dystonia
chronic headache
chronic musculoskeletal pain
Drug Administration
eye muscles
FDA-approved indications
involuntary contraction
multiple sclerosis
neuromuscular disorder
non-cosmetic
oculomotor disorders strabismus
severe primary axillary hyperhidrosis
spastic disorders
Temporary improvement
temporary treatment
vocal cords