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Case Reports Multicenter Study Clinical Trial
Fully Implantable Peripheral Nerve Stimulation for Hemiplegic Shoulder Pain: A Multi-Site Case Series With Two-Year Follow-Up.
- Richard D Wilson, Maria E Bennett, Nguyen Vu Q C VQC Carolinas HealthCare/Charlotte Institute of Rehabilitation, Charlotte, NC, USA., William C Bock, Michael W O'Dell, Thomas K Watanabe, Russell H Amundson, Harry A Hoyen, and John Chae.
- MetroHealth Rehabilitation Institute of Ohio, MetroHealth Medical Center, Cleveland, OH, USA.
- Neuromodulation. 2018 Apr 1; 21 (3): 290-295.
ObjectiveTo 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.ParticipantsParticipants with moderate to severe shoulder pain not responsive to conservative therapies for six months.MethodsDuring 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.ResultsTwenty-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.ConclusionsThis 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.© 2017 International Neuromodulation Society.
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