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Therapy Reduces Spasticity-Related Pain from Stroke in New Study

Post-stroke spasticity (PSS) leads to higher incidence of pain compared to those with normal muscle tone

A PPM Brief

New results from the Spasticity In Stroke-Randomised Study (SISTERS) trial1 show that Intrathecal Baclofen Therapy (ITB Therapy) with Lioresal Intrathecal (baclofen injection) reduces spasticity-related pain and improves quality of life more than conventional medical management (CMM) with oral antispastic medications. Spasticity, a condition where certain muscles are constantly being contracted, is a relatively common long-term complication of stroke, with up to 13% of post-stroke patients suffering from severe disabling spasticity.2

Over six months, results of the study show that ITB was more effective than CMM using the Numerical Pain Rating Scale (NPRS) scores for actual and least spasticity-related pain. A majority of ITB patients (73% vs. 48% of CMM patients) reported satisfaction with spasticity reduction at the 6-month mark. Randomizing 60 patients in Europe and the United States, the results from the paper stem from pre-specified secondary outcomes of the SISTERS trial, including assessment of pain and quality of life measures and patient satisfaction with the therapy. Despite adverse effects consistent with the known safety profile of ITB Therapy, no patient discontinued the therapy due to treatment-related adverse events; around half of the adverse events occurred during the implant and titration phase.

(Source: 123RF)

"These secondary study results demonstrate that, in addition to treating excessive muscle tone associated with spasticity, ITB Therapy also addresses spasticity-related pain and quality of life and should be considered when assessing treatment options for post-stroke spasticity," said study investigator Michael Creamer, DO, of Central Florida Pain Relief Centers in Orlando, FL.

SISTERS is the first randomized, controlled, open-label, multicenter study to evaluate the efficacy and safety of ITB Therapy versus CMM with oral antispastic medications for treatment of PSS after six months of active treatment.1 This demonstration of greater improvements in pain and quality of life enhance the existing data associated with ITB's impact on spasticity, according to a company press release.3

Last updated on: October 5, 2018
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