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The following is a summary of “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,” published in the June 2024 issue of Pain by Kapural et al.
Researchers conducted a retrospective analysis to evaluate the effectiveness and safety of high-frequency nerve block therapy for chronic post-amputation pain (PAP) and phantom limb pain.
They conducted the QUEST study with 180 unilateral lower-limb amputees experiencing severe PAP. Among them, 170 received the Altius device and were randomly assigned in a 1:1 ratio to either the active-sham or treatment groups. The primary endpoint focused on responders who reported at least 50% pain relief within 30 minutes after treatment in more than 50% of their self-administered sessions over the three-month randomized period. Differences between the active treatment and sham control groups were analyzed alongside various secondary outcomes.
The results showed that at 30 minutes (primary outcome), 24.7% of those in the treatment group met responder criteria, compared to 7.1% in the control group (P=0.002). At 120 minutes post-treatment, responder rates were 46.8% for the treatment group and 22.2% for the control group (P=0.001). The treatment group demonstrated a notably greater improvement in Brief Pain Inventory interference score (2.3 ± 0.29) compared to the control group (1.3 ± 0.26) (P=0.01). Opioid usage showed a trend toward greater reduction in the treatment group, although not statistically significant. The incidence of AEs did not differ significantly between the treatment and control groups.
Investigators concluded that high-frequency nerve block treatment significantly reduced chronic PAP, improved QoL, and potentially lessened opioid use.