Richard D Wilson1,2,3, Maria E Bennett4, Vu Q C Nguyen5, William C Bock6, Michael W O'Dell7,8, Thomas K Watanabe9, Russell H Amundson10, Harry A Hoyen2,3,11, John Chae1,2,3. 1. MetroHealth Rehabilitation Institute of Ohio, MetroHealth Medical Center, Cleveland, OH, USA. 2. Case Western Reserve University, School of Medicine, Cleveland, OH, USA. 3. Cleveland Functional Electrical Stimulation Center, Cleveland, OH, USA. 4. SPR Therapeutics, Inc., Cleveland, OH, USA. 5. Carolinas HealthCare/Charlotte Institute of Rehabilitation, Charlotte, NC, USA. 6. Carolinas HealthCare/Sanger Heart and Vascular Institute, Charlotte, NC, USA. 7. Weill Cornell Medical College, New York, NY, USA. 8. Department of Rehabilitation Medicine, New York-Presbyterian Hospital, Weill Cornell Medical Center, New York, NY, USA. 9. Albert Einstein Healthcare Network/Moss Rehabilitation, Elkins Park, PA, USA. 10. United Healthcare Clinical Services, Philadelphia, PA, USA. 11. Department of Orthopaedic Surgery, MetroHealth Medical Center, Cleveland, OH, USA.
Abstract
OBJECTIVE: To explore the feasibility and safety of a single-lead, fully implantable peripheral nerve stimulation system for the treatment of chronic shoulder pain in stroke survivors. PARTICIPANTS: Participants with moderate to severe shoulder pain not responsive to conservative therapies for six months. METHODS: During the trial phase, which included a blinded sham introductory period, a percutaneous single-lead peripheral nerve stimulation system was implanted to stimulate the axillary nerve of the affected shoulder. After a three-week successful trial, participants received an implantable pulse generator with an electrode placed to stimulate the axillary nerve of the affected shoulder. Outcomes included pain, pain interference, pain-free external rotation range of motion, quality of life, and safety. Participants were followed for 24 months. RESULTS: Twenty-eight participants underwent trial stimulation and five participants received an implantable pulse generator. The participants who received the implantable generator experienced an improvement in pain severity (p = 0.0002). All five participants experienced a 50% or greater pain reduction at 6 and 12 months, and four experienced at least a 50% reduction at 24 months. There was an improvement in pain interference (p < 0.0001). There was an improvement in pain-free external ROM (p = 0.003). There were no serious adverse events related to the device or to the procedure. CONCLUSIONS: This case series demonstrates the safety and efficacy of a fully implantable axillary PNS system for chronic HSP. Participants experienced reduction in pain, reduction in pain interference, and improved pain-free external rotation ROM. There were no serious adverse events associated with the system or the procedure.
OBJECTIVE: To explore the feasibility and safety of a single-lead, fully implantable peripheral nerve stimulation system for the treatment of chronic shoulder pain in stroke survivors. PARTICIPANTS: Participants with moderate to severe shoulder pain not responsive to conservative therapies for six months. METHODS: During the trial phase, which included a blinded sham introductory period, a percutaneous single-lead peripheral nerve stimulation system was implanted to stimulate the axillary nerve of the affected shoulder. After a three-week successful trial, participants received an implantable pulse generator with an electrode placed to stimulate the axillary nerve of the affected shoulder. Outcomes included pain, pain interference, pain-free external rotation range of motion, quality of life, and safety. Participants were followed for 24 months. RESULTS: Twenty-eight participants underwent trial stimulation and five participants received an implantable pulse generator. The participants who received the implantable generator experienced an improvement in pain severity (p = 0.0002). All five participants experienced a 50% or greater pain reduction at 6 and 12 months, and four experienced at least a 50% reduction at 24 months. There was an improvement in pain interference (p < 0.0001). There was an improvement in pain-free external ROM (p = 0.003). There were no serious adverse events related to the device or to the procedure. CONCLUSIONS: This case series demonstrates the safety and efficacy of a fully implantable axillary PNS system for chronic HSP. Participants experienced reduction in pain, reduction in pain interference, and improved pain-free external rotation ROM. There were no serious adverse events associated with the system or the procedure.
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