Intrathecal Baclofen More Effective Than Oral Medication for Treating Pain in Patients With Poststroke Spasticity


Results from the SISTERS trial (NCT01032239) show that intrathecal administration (ITB Therapy; Medtronic, Dublin, Ireland) of baclofen (Lioresal Intrathecal; Saol Therapeutics, Roswell, GA) is a more effective treatment for pain in patients with poststroke spasticity compared to conventional medical management (CMM) with oral medications (Stroke:August 14, 2018). 

In the SISTERS trial, an open-label study, 60 patients who had poststroke spasticity (PSS)—which occurs in approximately 13% of patients who experienced stroke—were randomized into 1 of 2 groups receiving either CMM (n = 29) or ITB therapy (n = 31). Enrolled patients had spasticity in 2 or more extremities, an Ashworth Scale score of 3 or more in 2 or more lower extremity muscle groups, and failure to respond to other treatments for 6 months or more. Both groups of patients received physical therapy throughout the study. 

In addition to have a greater effect on reducing spasticity (J Neurol Neurosurg. 2018;89:642-650) compared to CMM, ITB treatment had greater effects on reducing pain and improving quality of life scores. Reduction in pain was measured with the Numeric Pain Rating Scale (NPRS) and quality of life was measured with the EruoQoL scale. Results are shown in the Table. 

Table. Effect of Treatment on Pain and Quality of Life Scale Scores


Intrathecal baclofen treatment

Conventional medical management

Significance of difference between median changes

Actual pain score mean change (median change)

-1.17 +/-3.17 (-1)

0.00 +/ 3.29 (0)

P = .038

Least pain score mean change (median change)

-1.61 +/-2.29 (-1)

0.24 +/ 3.07 (0)

P = .0136

EuroQoL 5-dimensional 3 level utility score change

0.09 +/-0.26 (0.07)

0.01+/ 0.16 (0)

P = 0.0197

Satisfaction with treatment

73% of patients

48% of patients


Between-group differences were not statistically significant for EuroQol–5 dimensional 3 level visual analog scale, stroke-specific QoL summary, or NPRS worst pain scores, although ITB patients showed greater numeric improvements from baseline during follow-up. Adverse events were more frequent in patients treated with ITB, although these were consistent with the known safety profile for ITB. No patient discontinued ITB Therapy due to treatment-related adverse events.


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