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First long-term study to evaluate repeated treatment with BoNTA for post-stroke spasticity

Published on October 30, 2005 at 7:26 PM · No Comments

New research shows that repeated treatments of botulinum toxin type A (BoNTA) over one year after a stroke can improve muscle tone and reduce pain in the arms and hands, making it easier for patients to dress themselves and perform personal hygiene.

"The treatment resulted in sustained and meaningful functional improvement that makes a difference in the daily lives of stroke patients and the people who care for them," said Allison Brashear, M.D., professor and chairman of neurology at Wake Forest University Baptist Medical Center.

The findings were presented today at the 2005 Annual Meeting of the American Association of Physical Medicine and Rehabilitation (AAPM&R) in Philadelphia. The study was conducted by Brashear and colleagues while she was at Indiana University School of Medicine.

This was the first long-term study to evaluate repeated treatment with BoNTA for post-stroke spasticity, a muscle tightness that inhibits movement. Brashear and colleagues had previously reported (New England Journal of Medicine, August 2002) that one-time injections of BoNTA are safe and effective in people with wrist and finger spasticity after a stroke.

The study reported on today involved 35 centers and included 279 stroke patients with wrist, hand or elbow spasticity. Disabling spasticity affects between 17 percent and 30 percent of stroke survivors and can lead to functional limitations, discomfort and pain. Upper limb spasticity can interfere with patients' mobility, comfort and their ability to dress, wash or feed themselves and perform other activities of daily living.

During the year-long study, all study participants received up to five treatments with BoNTA, which is sold under the trade name BOTOX®. For the study, the BoNTA injections were given at the wrist, thumbs, fingers and elbows to block overactive nerve impulses that trigger excessive muscle contractions.

Researchers found that at week six of the study, muscle tone in the wrist, fingers, thumb, and elbow was markedly improved from baseline, and was sustained throughout the study. The study also measured functional disability in four areas: hygiene, dressing, limb posture and pain. Before the first treatment, patients selected an area that was most important to them. On a four-point scale that ranged from "no disability" to "severe disability," at least 50 percent of patients achieved a 1-point or greater improvement in the area they targeted.

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