This is a bibliographic record of a published health technology assessment. The agency responsible for the publication has subsequently been disbanded. No evaluation of the quality of this assessment has been made for the HTA database.

This report aims to assess the effectiveness of botulinum toxin-A (BTX-A) for the treatment of pain associated with neuromuscular disorders.

BTX-A (Botox) has been found to be safe and effective for a number of clinical conditions.

Presently, BTX-A has been approved by the FDA for the treatment of cervical dystonia in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia, and for treatment of strabismus and blepharospasm associated with dystonia.

Listed below are clinical applications for which BTX-A is not approved by the FDA, but where data exists to support the clinical use of BTX-A: Spasmodic torticollis Writer's cramp with significant wrist-joint deviation Spasmodic dysphonia Dynamic contracture in cerebral palsy patients Post Stroke Spasticity Myofascial pain syndrome Chronic low back pain

Following are the clinical conditions where insufficient data exists to support the clinical use of BTX-A and none of these are FDA approved indications: 'Off' painful dystonia in Parkinson's disease patients Rigidity in Parkinson's disease patients TMJ disorders and Bruxism Fixed contracture in cerebral palsy patients Spasticity associated with multiple sclerosis Tension headache Migraine Whiplash associated with neck-pain Spasticity associated with Perinatal hypoxia Progressive supranuclear palsy Cortical basal degeneration Extensor hallucis longus dystonia Writer's cramp with neutral wrist position Essential tremor Stenographer's cramp Sixth nerve palsy

BTX-A treatment is potentially a painful procedure. It is contraindicated in the presence of infection at the injection site(s) and in individuals with known hypersensitivity to any ingredient in the formulation.

Individuals with peripheral motor neuropathic diseases or neuromuscular junctional disorders should receive BTX-A treatment with caution. BTX-A should also be used with caution in patients receiving aminoglycosides or other agents interfering with neuromuscular transmission.

Formation of neutralizing antibodies to BTX-A may reduce its effectiveness by inactivating the biological activity of the toxin. The rate of formation of these neutralizing antibodies in patients receiving BTX-A treatment has not been well studied and the critical factors for neutralizing antibody formation have not been well characterized. The effect of the long term use of BTX-A has not been studied, however, the reformulated BTX-A has a lower protein content that may decrease the risk of antibody formation and the development of resistance.