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Clinical Trial
. 2018 Apr;21(3):290-295.
doi: 10.1111/ner.12726. Epub 2017 Nov 22.

Fully Implantable Peripheral Nerve Stimulation for Hemiplegic Shoulder Pain: A Multi-Site Case Series With Two-Year Follow-Up

Richard D Wilson  1   2   3 , Maria E Bennett  4 , Vu Q C Nguyen  5 , William C Bock  6 , Michael W O'Dell  7   8 , Thomas K Watanabe  9 , Russell H Amundson  10 , Harry A Hoyen  2   3   11 , John Chae  1   2   3
Affiliations
Clinical Trial

Fully Implantable Peripheral Nerve Stimulation for Hemiplegic Shoulder Pain: A Multi-Site Case Series With Two-Year Follow-Up

Richard D Wilson et al. Neuromodulation. 2018 Apr.

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.

Keywords: Peripheral nerve stimulation; stroke.

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Conflict of interest statement

Conflict of Interest: Statement Dr. Wilson is a consultant to SPR Therapeutics. Ms. Bennett is an employee of SPR Therapeutics. Dr. Chae is a consultant and chief medical advisor to SPR Therapeutics and owns equity in SPR Therapeutics. The remaining authors have no potential conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Participant flow.
Figure 2
Figure 2
Worst Pain in the Last 7 Days, BPI-SF3. Time T to 0 represents the trial stage, which consisted of a 3-week, blinded sham introductory period and a 3-week active stimulation period. The shaded area represents the 95% confidence intervals.
Figure 3
Figure 3
Patient Global Impression of Change.
See this image and copyright information in PMC

References

    1. Adey-Wakeling Z, Arima H, Crotty M, Leyden J, Kleinig T, Anderson CS, et al. Incidence and associations of hemiplegic shoulder pain poststroke: prospective population-based study. Arch Phys Med Rehabil. 2015;96(2):241–7 e1. - PubMed
    1. Chae J, Mascarenhas D, Yu DT, Kirsteins A, Elovic EP, Flanagan SR, et al. Poststroke shoulder pain: its relationship to motor impairment, activity limitation, and quality of life. Arch Phys Med Rehabil. 2007;88(3):298–301. - PubMed
    1. Adey-Wakeling Z, Liu E, Crotty M, Leyden J, Kleinig T, Anderson CS, et al. Hemiplegic Shoulder Pain Reduces Quality of Life After Acute Stroke: A Prospective Population-Based Study. Am J Phys Med Rehabil. 2016;95(10):758–63. - PubMed
    1. Chae J, Yu DT, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, et al. Intramuscular electrical stimulation for hemiplegic shoulder pain: a 12-month follow-up of a multiple-center, randomized clinical trial. American journal of physical medicine & rehabilitation/Association of Academic Physiatrists. 2005;84(11):832–42. - PubMed
    1. Wilson RD, Harris MA, Gunzler DD, Bennett ME, Chae J. Peripheral Nerve Stimulation for the Treatment of Chronic Subacromial Impingement Syndrome: A Case Series. Neuromodulation. 2014;17(8):771–6. - PMC - PubMed

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