The secondary endpoints of the Spasticity In Stroke-Randomised Study (SISTERS) trial, demonstrate Intrathecal Baclofen Therapy (ITB) with baclofen injection reduces spasticity-related pain and improves quality of life more than conventional medical management (CMM) with oral antispastic medications.
The online publication of “Effect of intrathecal baclofen on pain and quality of life in post-stroke spasticity: a randomised trial (SISTERS)”, in Stroke, was announced by Medtronic in a press release.
“Despite its known benefits, ITB Therapy continues to be underused when it comes to treating severe spasticity in post-stroke patients,” said lead author and study investigator Michael Creamer, of Central Florida Pain Relief Centers in Orlando, USA. “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.”
Results of the study show ITB was more effective than CMM over six months using Numerical Pain Rating Scale (NPRS) scores for actual and least spasticity-related pain. Further, a majority of ITB patients (73% vs. 48% of CMM patients) reported satisfaction with spasticity reduction at six months. Demonstration of greater improvements in pain and QoL with ITB compared to CMM in this trial enhance existing data associated with ITB’s impact on spasticity.
SISTERS is the first randomised, controlled, open-label, multicentre study to evaluate the efficacy and safety of ITB Therapy versus CMM with oral antispastic medications for treatment of PSS after six months’ active treatment. The study randomised 60 patients in Europe and the United States. Primary outcomes results were published in January 2018 in the Journal of Neurology, Neurosurgery & Psychiatry. In this new paper, the results are presented for other pre-specified secondary outcomes of SISTERS, including assessment of pain and QoL measures and patient satisfaction with therapy.
More patients reported adverse events in the ITB group (24/25 patients, 96%; 149 events) compared to CMM (22/35, 63%; 77 events), although events were generally consistent with the known safety profile of ITB Therapy. Around half of the drug, device and procedure related adverse events occurred during implant and titration phase. No patient discontinued ITB Therapy due to treatment related adverse events.
“Spasticity-related pain is a common and often overlooked after-effect of stroke that can also negatively impact quality of life, especially in patients experiencing post-stroke spasticity,” said Charlie Covert, vice president and general manager, Targeted Drug Delivery, Medtronic Pain Therapies. “At Medtronic, we’re committed to raising awareness of ITB Therapy as an effective treatment for severe PSS. We are pleased these results show that additional improvements are possible with improved spasticity management.”