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.
From 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).
All correspondence and requests for reprints should be addressed to: Richard D. Wilson, MD, Department of Physical Medicine and Rehabilitation, MetroHealth Medical Center, 4229 Pearl Rd, N5-36, Cleveland, OH 44109.
Supported by grant R01HD059777 and K24HD054600 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Clinical and Translational Science Collaborative of Cleveland and UL1TR000439 from the National Center for Advancing Translational Sciences (NCATS) component of the National Institutes of Health and NIH Roadmap for Medical Research. Funding for this study from SPR Therapeutics, LLC, has been paid to Dr Wilson’s institution.
Presented, in part, at the INS 11th World Congress, Berlin, Germany, June 8–13, 2013.
Richard D. Wilson is a consultant to SPR Therapeutics, LLC. Maria Bennett is an employee of SPR Therapeutics, LLC. John Chae is a consultant and chief medical advisor to SPR Therapeutics, LLC. Dr Chae also owns equity in SPR Therapeutics, LLC. Douglas D. Gunzler has nothing to disclose. SPR Therapeutics, LLC, has a commercial interest in the device presented in this article. The Smartpatch PNS System is an investigational device in the United States. IRB approval: IRB09-00502. Clinical Trials Registration: NCT01123382.