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Peripheral nerve stimulation compared with usual care for pain relief of hemiplegic shoulder pain: a randomized
Richard D Wilson1, Douglas D Gunzler, Maria E Bennett
1From the Department of Physical Medicine and Rehabilitation, Case Western Reserve University at MetroHealth Medical Center, Cleveland, Ohio (RDW, JC); Cleveland Functional Electrical Stimulation Center (RDW, JC) and Department of Biomedical Engineering (JC), Case Western Reserve University, Cleveland, Ohio; Center for Healthcare Research and Policy, Case Western Reserve University/MetroHealth Medical Center, Cleveland, Ohio (DDG); and SPR Therapeutics, LLC, Cleveland, Ohio (MEB).
Objective:
This study sought to establish the efficacy of single-lead, 3-wk peripheral nerve stimulation (PNS) therapy for pain reduction in stroke survivors with chronic hemiplegic shoulder pain.
Design:
This study is a single-site, pilot, randomized controlled trial of adults with chronic shoulder pain after stroke. Participants were randomized to receive a 3-wk treatment of single-lead PNS or usual care. The primary outcome was the worst pain in the last week (Brief Pain Inventory, Short Form, question 3) measured at baseline and weeks 1, 4, 12, and 16. The secondary outcomes included pain interference (Brief Pain Inventory, Short Form, question 9), pain measured by the ShoulderQ Visual Graphic Rating Scales, and health-related quality-of-life (Short-Form 36 version 2).
Results:
Twenty-five participants were recruited, 13 to PNS and 12 to usual care. There was a significantly greater reduction in pain for the PNS group compared with the controls, with significant differences at 6 and 12 wks after treatment. Both PNS and usual care were associated with significant improvements in pain interference and physical health-related quality-of-life.
Conclusions:
Short-term PNS is a safe and efficacious treatment of shoulder pain. Pain reduction is greater compared with usual care and is maintained for at least 12 wks after treatment.
