Botulinum neurotoxin serotype A: a clinical update on non-cosmetic uses.
ABSTRACT Clinical experience with botulinum toxin type A for non-cosmetic uses that are approved by the Food and Drug Administration (FDA) and various other non-cosmetic uses that are not approved by FDA, including some applications that are widely known and others that currently are emerging, is discussed.
FDA-approved indications for botulinum toxin type A (Botox) include the temporary treatment of cervical dystonia (a neuromuscular disorder involving the head and neck), the oculomotor disorders strabismus (improperly aligned eyes) and blepharospasm (involuntary contraction of the eye muscles), and severe primary axillary hyperhidrosis (excessive sweating). Other uses of botulinum toxin type A that are widely known but not approved by FDA include spastic disorders associated with injury or disease of the central nervous system including trauma, stroke, multiple sclerosis, or cerebral palsy and focal dystonias affecting the limbs, face, jaw, or vocal cords. Treatment and prevention of chronic headache and chronic musculoskeletal pain are emerging uses for botulinum toxin type A.
Many of the conditions for which botulinum toxin type A has been explored are common and difficult to treat. Temporary improvement in symptoms is associated with botulinum toxin type A injection, and repeat treatment often is required. The drug is well tolerated and has a wide margin of safety.
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.[show abstract] [hide abstract]
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