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Percutaneous Peripheral Nerve Stimulation for the Treatment Of Original article Reg Anesth Pain Med: first published as 10.1136/rapm-2018-100109 on 5 April 2019. Downloaded from Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial Christopher Gilmore,1 Brian Ilfeld, 2 Joshua Rosenow,3 Sean Li,4 Mehul Desai,5 Corey Hunter,6 Richard Rauck,1 Leonardo Kapural,1 Antoun Nader,7 John Mak,4 Steven Cohen, 8 Nathan Crosby, 9 Joseph Boggs9 For numbered affiliations see ABSTRact pain (RLP) and phantom limb pain (PLP), each end of article. Background and objectives Chronic neuropathic having significant neuropathic components.2 3 The pain is a common challenging condition following prevalence of persistent pain has been reported as Correspondence to amputation. Recent research demonstrated the high as 74% for RLP and 85% for PLP, and many Dr Christopher Gilmore, Center 3 for Clinical Research, NC 27103, feasibility of percutaneously implanting fine-wire coiled amputees report a combination of RLP and PLP. USA; cgilmore@ ccrpain. com peripheral nerve stimulation (PNS) leads in proximity Chronic neuropathic pain in amputees can also to the sciatic and femoral nerves for postamputation decrease function and quality of life, leading to Data from this study were pain. A multicenter, double-blinded, randomized, significantly increased risk of depression.4 5 presented at the 2018 Napa Pain Conference in Napa, placebo-controlled study collected data on the safety Neuropathic pain in amputees has historically California, in August 16–19, and effectiveness of percutaneous PNS for chronic been a complex and challenging condition to treat. 2018, and at the Military Health neuropathic pain following amputation. Many therapies have been employed, including System Research Symposium in Methods Twenty-eight lower extremity amputees with opioid and non-opioid oral analgesics, nerve Kissimmee, Florida, in August postamputation pain were enrolled. Subjects underwent blocks, spinal cord stimulation (SCS), and physical 20–23, 2018. ultrasound-guided implantation of percutaneous PNS and psychological therapies, but few controlled Received 11 September 2018 leads and were randomized to receive PNS or placebo trials demonstrate consistent and effective pain Revised 30 January 2019 for 4 weeks. The placebo group then crossed over and management.2 3 6 7 Peripheral nerve stimulation Accepted 16 February 2019 all subjects received PNS for four additional weeks. The (PNS) has been used effectively for neuropathic Published Online First 8–10 5 April 2019 primary efficacy endpoint evaluated the proportion of pain, including in cases of postamputation pain. subjects reporting ≥50% pain reduction during weeks Historically, PNS leads were designed to be located 1–4. near or in contact with nerves, often using devices Results A significantly greater proportion of subjects adapted from SCS. This practice was consequently receiving PNS (n=7/12, 58%, p=0.037) demonstrated limited by the complexity, cost, and invasiveness http://rapm.bmj.com/ ≥50% reductions in average postamputation pain during of surgical lead implantation, and risk of nerve weeks 1–4 compared with subjects receiving placebo damage, lead migration, or failure.11–13 (n=2/14, 14%). Two subjects were excluded from Unmet treatment needs for dedicated peripheral efficacy analysis due to eligibility changes. Significantly neuromodulation applications have resulted in the greater proportions of PNS subjects also reported ≥50% introduction of new devices and techniques that reductions in pain (n=8/12, 67%, p=0.014) and pain allow for percutaneous, ultrasound-guided lead 10 14 interference (n=8/10, 80%, p=0.003) after 8 weeks implantation and the development of a PNS on October 1, 2021 by guest. Protected copyright. of therapy compared with subjects receiving placebo system designed specifically for use in the periphery (pain: n=2/14, 14%; pain interference: n=2/13, 15%). to overcome many of the challenges associated Prospective follow-up is ongoing; four of five PNS with previous techniques.15 16 A PNS system whose subjects who have completed 12-month follow-up to leads may be implanted under ultrasound guid- date reported ≥50% pain relief. ance to provide pain relief for chronic and acute Conclusions This work demonstrates that percutaneous pain indications is now Food and Drug Adminis- ► http:// dx. doi. org/ 10. 1136/ PNS therapy may provide enduring clinically significant tration-cleared. The system uses a percutaneous rapm- 2019- 100488 pain relief and improve disability in patients with chronic fine-wire coiled lead designed to reduce lead migra- neuropathic postamputation pain. tion and has been reported to have a significantly Trial registration number NCT01996254. lower risk of infection than other neurostimulation electrodes.17–21 The availability of such a system © American Society of Regional Anesthesia & Pain Medicine provides additional therapeutic options for the 2019. Re-use permitted under treatment of pain. CC BY-NC. No commercial INTRODUCTION A previous study demonstrated the feasibility of re-use. Published by BMJ. Chronic neuropathic pain is a common and chal- percutaneously implanting fine-wire coiled PNS To cite: Gilmore C, lenging condition following amputation. There are leads in proximity to the sciatic and femoral nerves 18 Ilfeld B, Rosenow J, et al. approximately two million amputees in the USA, in amputees with neuropathic pain. In a series of Reg Anesth Pain Med with nearly 200 000 amputations performed annu- 16 subjects, 14 (88%) obtained clinically signifi- 2019;44:637–645. ally.1 Postamputation pain includes residual limb cant relief of RLP and/or PLP. Nine subjects who Gilmore C, et al. Reg Anesth Pain Med 2019;44:637–645. doi:10.1136/rapm-2018-100109 637 Original article Reg Anesth Pain Med: first published as 10.1136/rapm-2018-100109 on 5 April 2019. Downloaded from proceeded to a 2-week stimulation home trial reported an average Interventions 72% reduction in RLP and 81% reduction in PLP, and improve- The femoral and sciatic nerves were targeted with percutaneous ments in functional measures like pain interference (81%–83% PNS leads under ultrasound guidance (figure 1).18 A percu- reductions in RLP and PLP interference).18 Due to the need for taneous lead was directed toward the femoral nerve with the data from a randomized study to validate and quantify potential subject supine using a lateral approach approximately 1–2 cm benefits, the present multicenter, randomized, double-blinded, distal to the inguinal crease. The femoral artery, fascia iliaca, and placebo-controlled, partial-crossover study was conducted to fascia lata were identified as ultrasonic landmarks. The lead was collect data on the safety and effectiveness of percutaneous PNS implanted remote (0.5–3 cm) from the nerve to enable selec- 15 16 18 for chronic neuropathic pain in amputees. The primary hypoth- tive activation of large-diameter sensory fibers. A lead was esis was that percutaneous PNS provides clinically significant also directed toward the sciatic nerve with the subject prone pain relief in a statistically significantly greater proportion of or in lateral decubitus position. Ultrasonic landmarks included subjects than the placebo control group. the greater trochanter, ischial tuberosity, femur, and/or popli- teal artery to guide location of the lead remote from the nerve proximal to the level of amputation. Modifications to these METHODS approaches were made at the discretion of the investigator based Study design and population on patient-specific anatomy. This multicenter, randomized, double-blinded, placebo-con- The optimal lead location was determined using a stimulation trolled, partial-crossover study was designed to collect data testing protocol. The insertion site was cleansed using aseptic tech- regarding the safety and effectiveness of percutaneous PNS for nique, and cutaneous local anesthesia was administered, taking care chronic neuropathic pain in amputees. The study was prospec- to not deliver anesthetic to the target nerve where it may affect the tively registered on ClinicalT rials.gov in November 2013. stimulation response. A monopolar needle electrode was inserted Consenting patients were assessed for eligibility and random- to within 0.5–3 cm of the targeted femoral or sciatic nerve trunk ized at six enrolling sites in the USA. Key inclusion criteria were using the approaches described above. Test stimulation (asymmetric traumatic lower extremity amputation with healed and healthy charge-balanced biphasic pulse train, 100 Hz) was delivered to residual limb, RLP and/or PLP with an average daily score ≥4 confirm that comfortable stimulation-evoked sensations could be on a 0–10 pain rating scale, and age ≥18 years. Other than evoked in the regions of RLP and/or PLP. Stimulation intensity was requiring a healed and healthy residual limb, there were no adjusted by changing the amplitude (1–30 mA) and/or pulse width constraints on time since amputation. Key exclusion criteria (10–200 µs). If no sensations or undesired sensations (eg, local or were changes in pain medications in the previous 4 weeks, distal motor activation, local or distal discomfort) were evoked, Beck Depression Inventory-II (BDI-II) score >20, compromised the test needle was redirected in small increments until comfort- immune system, diabetes mellitus type I or II, implanted elec- able sensations were evoked that covered the regions of pain. Once trical stimulation device,
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