Medtronic has said that treatment with Intrathecal Baclofen Therapy (ITB therapy) vs. oral medication demonstrated quality of life improvement and reduction in spasticity-related pain.
The company announced the online publication of ‘Effect of intrathecal baclofen on pain and quality of life in post-stroke spasticity: a randomized trial (SISTERS)’ in Stroke: A Journal of Cerebral Circulation (Stroke).
The results, secondary endpoints of the ‘Spasticity In Stroke-Randomised Study’ (SISTERS) trial, demonstrate 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.
Stroke can result in several physical, emotional and daily living problems along with pain. Spasticity is a condition where certain muscles are constantly being contracted, which is a relatively common long-term complication of stroke. It is estimated that up to 13% of post-stroke patients suffer from severe disabling spasticity.
Patients with post-stroke spasticity (PSS) also experience number of pain instances and lower health-related quality of life (QoL) compared to patients with normal muscle tone.
Results from Medtronic’s study show that IBT is more effective than CMM over six months using Numerical Pain Rating Scale (NPRS) scores for actual and least spasticity-related pain. Furthermore, majority of ITB patients (73% vs. 48% of CMM patients) reported reduction of spasticity in the sixth month. The study has significantly added to the existing data on ITB’s impact on spasticity.
SISTERS is claimed to be the first randomised, controlled, open-label, multicentre study to evaluate the efficacy and safety of ITB Therapy compared to CMM with oral antispastic medications for treatment of PSS after six months’ active treatment.
The study was conducted on 60 randomised patients in Europe and the US. Primary outcome results were published this January, in the Journal of Neurology, Neurosurgery & Psychiatry.
In the new paper, the results were presented for other pre-specified secondary outcomes of SISTERS, including pain assessment and quality of life measures and patient satisfaction with therapy.
More patients stated 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.