Randomized Placebo-Controlled Trial of 60-Day Percutaneous Peripheral Nerve Stimulation Treatment Indicates Relief of Persistent Postoperative Pain, and Improved Function After Knee Replacement.

Autor: Goree JH; Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR, USA. Electronic address: JHGoree@uams.edu., Grant SA; Department of Anesthesiology, University of North Carolina School of Medicine, Chapel Hill, NC, USA., Dickerson DM; Department of Anesthesiology, Critical Care, and Pain Medicine, Endeavor Health, Evanston, IL, USA; The University of Chicago, Pritzker School of Medicine, Chicago, IL, USA., Ilfeld BM; Department of Anesthesiology, University of California San Diego, La Jolla, CA, USA., Eshraghi Y; Department of Anesthesiology, Ochsner Medical Center, New Orleans, LA, USA., Vaid S; Better Health Clinical Research, Newnan, GA, USA., Valimahomed AK; Grammercy Pain Center, Holmdel, NJ, USA., Shah JR; Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR, USA., Smith GL; Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR, USA., Finneran JJ; Department of Anesthesiology, University of California San Diego, La Jolla, CA, USA., Shah NN; Department of Anesthesiology, Critical Care, and Pain Medicine, Endeavor Health, Evanston, IL, USA; The University of Chicago, Pritzker School of Medicine, Chicago, IL, USA., Guirguis MN; Department of Anesthesiology, Ochsner Medical Center, New Orleans, LA, USA., Eckmann MS; Department of Anesthesiology, University of Texas San Antonio, San Antonio, TX, USA., Antony AB; The Orthopedic Institute, Gainesville, FL, USA., Ohlendorf BJ; Department of Anesthesiology, Duke University Hospital, Durham, NC, USA., Gupta M; Neuroscience Research Center, Overland Park, KS, USA., Gilbert JE; SPR Therapeutics, Cleveland, OH, USA., Wongsarnpigoon A; SPR Therapeutics, Cleveland, OH, USA., Boggs JW; SPR Therapeutics, Cleveland, OH, USA.
Jazyk: angličtina
Zdroj: Neuromodulation : journal of the International Neuromodulation Society [Neuromodulation] 2024 Jul; Vol. 27 (5), pp. 847-861. Date of Electronic Publication: 2024 May 11.
DOI: 10.1016/j.neurom.2024.03.001
Abstrakt: Objectives: Total knee arthroplasty (TKA) is an effective surgery for end-stage knee osteoarthritis, but chronic postoperative pain and reduced function affect up to 20% of patients who undergo such surgery. There are limited treatment options, but percutaneous peripheral nerve stimulation (PNS) is a promising nonopioid treatment option for chronic, persistent postoperative pain. The objective of the present study was to evaluate the effect of a 60-day percutaneous PNS treatment in a multicenter, randomized, double-blind, placebo-controlled trial for treating persistent postoperative pain after TKA.
Materials and Methods: Patients with postoperative pain after knee replacement were screened for this postmarket, institutional review board-approved, prospectively registered (NCT04341948) trial. Subjects were randomized to receive either active PNS or placebo (sham) stimulation. Subjects and a designated evaluator were blinded to group assignments. Subjects in both groups underwent ultrasound-guided placement of percutaneous fine-wire coiled leads targeting the femoral and sciatic nerves on the leg with postoperative pain. Leads were indwelling for eight weeks, and the primary efficacy outcome compared the proportion of subjects in each group reporting ≥50% reduction in average pain relative to baseline during weeks five to eight. Functional outcomes (6-minute walk test; 6MWT and Western Ontario and McMaster Universities Osteoarthritis Index) and quality of life (Patient Global Impression of Change) also were evaluated at end of treatment (EOT).
Results: A greater proportion of subjects in the PNS groups (60%; 12/20) than in the placebo (sham) group (24%; 5/21) responded with ≥50% pain relief relative to baseline (p = 0.028) during the primary endpoint (weeks 5-8). Subjects in the PNS group also walked a significantly greater distance at EOT than did those in the placebo (sham) group (6MWT; +47% vs -9% change from baseline; p = 0.048, n = 18 vs n = 20 completed the test, respectively). Prospective follow-up to 12 months is ongoing.
Conclusions: This study provides evidence that percutaneous PNS decreases persistent pain, which leads to improved functional outcomes after TKA at EOT.
Competing Interests: Conflict of Interest Johnathan H. Goree serves as a consultant to Saluda Medical, Stratus Medical, and Abbott. David M. Dickerson serves as a consultant to Abbott, Vertos, Biotronik, and SPR Therapeutics, and has received honoraria for lectures from Nalu. Yashar Eshraghi serves as a consultant for Saluda Medical and SPR Therapeutics. Ali K. Valimahomed serves as a consultant for SPR Therapeutics, Nalu, Vertos, and Biotronik, and has received honoraria for lectures from the World Academy of Pain Medicine. Jarna R. Shah serves as a consultant for and has received honoraria from SPR Therapeutics. Maged N. Guirguis serves as a consultant for SPR Therapeutics, Nevro, Saluda, Boston Scientific, Abbott, Averitas Pharma, PainTeq, and Avanos. Maxim S. Eckmann serves as a consultant for Avanos and has participated on a data safety monitoring or advisory board for Abbott. Amorn Wongsarnpigoon is an inventor on >40 patents planned, issued, or pending related to peripheral nerve stimulation (PNS) and has stock/stock options with SPR Therapeutics. Joseph W. Boggs is an inventor on >100 patents planned, issued, or pending related to PNS and has stock/stock options with SPR Therapeutics. John E. Gilbert, Amorn Wongsarnpigoon, and Joseph W. Boggs are all employees of SPR Therapeutics as well in case that needs to be included. The remaining authors reported no conflicts of interest.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: