• March 4, 2020

    Two BSW sites enrolling participants in pivotal device trial for post-amputation residual limb pain

Two Baylor Scott & White sites are participating in a phase III trial examining the safety and efficacy of a device designed to electrically block nerve signals and alleviate pain. Use of this device is being studied in association with providing an effective, mechanism-based yet non-destructive, treatment for managing intractable limb pain in amputees. These locations are the only two sites in the state of Texas selected to participate in this trial.

The QUEST Post-Amputation Pain Study

The device is intended for the management of intractable lower limb pain of amputees. In addition to evaluating the safety and effectiveness of the device, a secondary objective of the study is determining the treatment impact on broader health outcomes, such as health-related quality of life measures and pain medication usage.

The primary effectiveness endpoint for the study will be a demonstrated reduction of pain levels by 50 percent from baseline (pre-treatment) to three months post-treatment, for more than 50 percent of pain episodes experienced during this time. Study success will be determined by a superiority test on the difference between responder rates in the Test group (those receiving the treatment) and Control group (those who do not receive the treatment).

The primary safety endpoint will be measured based on the incidence of reported and adjudicated serious adverse events from the time of patient consent to three months post-impact.

Inclusion Criteria include:

  • Age ≥ 21 years old
  • Unilateral amputated leg ≥ 12 months
  • Chronic post-amputation pain ≥ 6 months

Exclusion Criteria include:

  • Implanted with an active implantable medical device (i.e. pacemaker)
  • Confounding source of pain that interferes with reporting of limb pain
  • Uncontrolled diabetes
  • Untreated psychological condition (i.e. borderline personality)

Complete inclusion and exclusion criteria can be found online.

Baylor Scott & White Heart and Vascular Hospital – Dallas Baylor Scott & White Medical Center – Temple
Principal Investigator: John F Eidt, MD

Study Contact: Katalin Martits-Chalangari, 214-820-1722

Principal Investigator: William T, Bohannon, MD

Study Contact: Margarite Grable, 254-724-5861