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Neuromodulation. 2000 Oct;3(4):175-82. doi: 10.1046/j.1525-1403.2000.00175.x.

Safety and efficacy of intrathecal baclofen infusion by implantable pump for the treatment of severe spinal spasticity: a spanish multicenter study.

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1
Instituto Guttman, Barcelona; Hospital Universitario La Fe, Valencia, Spain.

Abstract

OBJECTIVE:

To assess long-term efficacy, safety and functional benefit of intrathecal baclofen for severe spinal spasticity.

MATERIALS AND METHODS:

This prospective multicenter study was performed in two stages: the first one consisted of an intrathecal bolus injection of baclofen, and the second of a continuous intrathecal baclofen infusion by means of an implantable pump. The sample consisted of 72 adult patients with severe spinal spasticity. Sixty-four were implanted and followed for 36 months. Muscular tone, spasms, and functional scales were evaluated before and periodically after administration of the drug, with a follow-up period of 36 months.

RESULTS:

A very significant decrease in tone and spasms was observed in all cases (p < 0.001). Tolerance appeared during the first 12 months, increasing doses from a mean initial dose of 83.2 μg (range 25-200 μg) to a mean final dose of 270 μg (range 25-800 μg). Later on, efficacy remained stable, except in cases of mechanical problems of the infusion system.

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