WINSTON-SALEM, N.C. -- Final results from a multi-center study shows that repeated treatments of botulinum toxin type A (BoNTA or Botox®) over one year is well tolerated and results in a significant decrease in spasticity, pain frequency and average pain intensity in upper limbs following stroke, according to research from a neurologist at Wake Forest University Baptist Medical Center.
Significant improvements in these outcome measures indicate a better quality of life for post-stroke patients suffering from spasticity-related pain, according to the researchers who presented their findings today at the annual meeting of the American Academy of Neurology in Boston. Spasticity is a disabling condition that leaves the muscles and tendons permanently shortened and inhibits movement.
"In the clinical setting, limb stiffness and pain are the most commonly reported symptoms of spasticity following a stroke, and relief of spasticity-related pain is a priority treatment goal for many patients," said Allison Brashear, M.D., professor and chairman of neurology at Wake Forest University Baptist Medical Center and head of the spasticity clinic at Wake Forest Baptist.
"Our study shows that treatment with botulinum toxin type A can lessen these disabling symptoms without treatment-limiting side effects, which in turn improves the ability of stroke patients to perform such essential activities of daily living as dressing themselves, maintaining good personal hygiene, and reaching for and grasping everyday objects."
This is the largest long-term study to evaluate repeated treatment with BoNTA for post-stroke spasticity. Brashear and colleagues had reported in 2002 that one-time injections of BoNTA are safe and effective in people with wrist and finger spasticity after a stroke.
About 58 percent of stroke survivors experience post-stroke spasticity, and only 51 percent of those are receiving treatment for that condition, according to the National Stroke Association.
A total of 279 patients were enrolled in the 12-month study of BoNTA to evaluate the efficacy and safety of repeated BoNTA treatments. All study participants received up to five treatments of BoNTA. For the study, the BoNTA injections were given at the elbow, wrist and fingers and/or thumbs flexor of the affected limb to block overactive nerve impulses that trigger excessive muscle contractions. Patients were assessed every six weeks for one year. Patients demonstrated a significant reduction in pain and excessive muscle tone at each follow-up. In addition, average pain intensity was significantly reduced.
"Early intervention with effective therapies is absolutely vital to prevent the profound disability that afflicts many stroke patients," said Brashear. "Having data to support a safe and effective profile for long-term treatment with BoNTA is significant for patients and caregivers. Many oral anti-spasticity medications are associated with systemic side effects such as sedation, mental confusion, dizziness and muscle weakness, all of which can seriously hinder rehabilitation after a stroke."
The study was funded by Allergan Inc., the pharmaceutical company that developed BoNTA or Botox®. Brashear's co-researchers were Elie Elovic, M.D., of Kessler Medical Rehabilitation Research and Education Corporation, West Orange, NJ; Darryl Kaelin, M.D., of the Shepherd Center, Atlanta, Ga., Robin McIntosh, B.S., Amanda VanDenburgh, Ph.D., Catherine Turkel, PharmD, M.B.A. and Frederick Beddingfield III, M.D., Ph.D., all with Allergan Inc.
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About Wake Forest University Baptist Medical Center: Wake Forest Baptist is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university's School of Medicine. The system comprises 1,298 acute care, psychiatric, rehabilitation and long-term care beds and is consistently ranked as one of "America's Best Hospitals" by U.S. News & World Report.