Primary 3-Month Outcomes of a Double-Blind Randomized Prospective Study (The QUEST Study) Assessing Effectiveness and Safety of Novel High-Frequency Electric Nerve Block System for Treatment of Post-Amputation Pain.

high-frequency nerve block neuromodulation peripheral nerve stimulation phantom limb pain post-amputation pain

Journal

Journal of pain research
ISSN: 1178-7090
Titre abrégé: J Pain Res
Pays: New Zealand
ID NLM: 101540514

Informations de publication

Date de publication:
2024
Historique:
received: 10 02 2024
accepted: 10 05 2024
medline: 11 6 2024
pubmed: 11 6 2024
entrez: 11 6 2024
Statut: epublish

Résumé

This multicenter, randomized, double-blinded, active sham-controlled pivotal study was designed to assess the efficacy and safety of high-frequency nerve block treatment for chronic post-amputation and phantom limb pain. QUEST enrolled 180 unilateral lower-limb amputees with severe post-amputation pain, 170 of whom were implanted with the Altius device, were randomized 1:1 to active-sham or treatment groups and reached the primary endpoint. Responders were those subjects who received ≥50% pain relief 30 min after treatment in ≥50% of their self-initiated treatment sessions within the 3-month randomized period. Differences between the active treatment and sham control groups as well as numerous secondary outcomes were determined. At 30-min, (primary outcome), 24.7% of the treatment group were responders compared to 7.1% of the control group (p=0.002). At 120-minutes following treatment, responder rates were 46.8% in the Treatment group and 22.2% in the Control group (p=0.001). Improvement in Brief Pain Inventory interference score of 2.3 ± 0.29 was significantly greater in treatment group than the 1.3 ± 0.26-point change in the Control group (p = 0.01). Opioid usage, although not significantly different, trended towards a greater reduction in the treatment group than in the control group. The incidence of adverse events did not differ significantly between the treatment and control groups. The primary outcomes of the study were met, and the majority of Treatment patients experienced a substantial improvement in PAP (regardless of meeting the study definition of a responder). The significant in PAP was associated with significantly improved QOL metrics, and a trend towards reduced opioid utilization compared to Control. These data indicate that Altius treatment represents a significant therapeutic advancement for lower-limb amputees suffering from chronic PAP.

Identifiants

pubmed: 38860215
doi: 10.2147/JPR.S463727
pii: 463727
pmc: PMC11164212
doi:

Types de publication

Case Reports Clinical Trial Journal Article

Langues

eng

Pagination

2001-2014

Informations de copyright

© 2024 Kapural et al.

Déclaration de conflit d'intérêts

Dr Leonardo Kapural reports grants and/or personal fees from Nalu, Biotronik, Saluda, Nevro, Presidio Medical, and Medtronic. Dr Erika Petersen reports grants and/or personal fees from Biotronik, Medtronic Neuromodulation, Nevro, Presidio Medical, Saluda, and SPR, outside the submitted work. Dr Jason Schwalb reports grants from Medtronic, SetPoint, Nevro, MeiraGTX; salary support for role as co-director of the Michigan Spine Surgery Improvement Collaborative, paid directly to employer from Blue Cross Blue Shield of Michigan, outside the submitted work. Dr Maged Guirguis reports personal fees from Nevro, Saluda Medical, Averitas Pharm, Pacira Medical, Boston Scientific, Abbott, Painteq Medical, outside the submitted work. The authors report no conflicts of interest in this work.

Auteurs

Leonardo Kapural (L)

Carolinas Pain Institute and Center for Clinical Research, Winston-Salem, NC, USA.

Jim Melton (J)

Department of Vascular Surgery, Cardiovascular Health Clinic, Oklahoma City, OK, USA.

Billy Kim (B)

Department of Vascular Surgery, The Surgical Clinic, Nashville, TN, USA.

Priyesh Mehta (P)

Department of Pain Medicine, Meta Medical Research Institute, Dayton, OH, USA.

Abindra Sigdel (A)

Department of Surgery, University of Louisville, Louisville, KY, USA.

Alexander Bautista (A)

Department of Anesthesiology and Perioperative Medicine, University of Louisville, Louisville, KY, USA.

Erika A Petersen (EA)

Department of Neurosurgery, University of Arkansas, Little Rock, AR, USA.

Konstantin V Slavin (KV)

Department of Neurosurgery, University of Illinois at Chicago, Chicago, IL, USA.
Department of Neurology, Jesse Brown VA Medical Center, Chicago, IL, USA.

John Eidt (J)

Department of Vascular Surgery, Baylor Scott and White Heart and Vascular Hospital Dallas, Dallas, TX, USA.

Jiang Wu (J)

Department of Anesthesiology & Pain Medicine, University of Washington Medical Center, Seattle, WA, USA.

Said Elshihabi (S)

Department of Neurosurgery, Legacy Brain & Spine Surgical Center, Atlanta, GA, USA.

Jason Matthew Schwalb (JM)

Department of Neurosurgery, Henry Ford Medical Group, Detroit, MI, USA.

H Edward Garrett (HE)

Department of Vascular Surgery, University of Tennessee-Memphis, Memphis, TN, USA.

Elias Veizi (E)

Department of Pain Medicine, VA Northeast OH Healthcare System, Cleveland, OH, USA.

Giancarlo Barolat (G)

Department of Neurosurgery, Barolat Neuroscience, Presbyterian/St Luke's Medical Center, Denver, CO, USA.

Ravi R Rajani (RR)

Department of Vascular Surgery, Emory University and Grady Memorial Hospital, Atlanta, GA, USA.

Peter C Rhee (PC)

Department of Orthopedic Surgery, Mayo Clinic, Rochester, MN, USA.

Maged Guirguis (M)

Department of Interventional Pain Management, Ochsner Health System, New Orleans, LA, USA.

Nagy Mekhail (N)

Department of Pain Management, Cleveland Clinic, Cleveland, OH, USA.

Classifications MeSH