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
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
2001-2014Informations 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.