Electrical Nerve Block for Amputation Pain
High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study
2 other identifiers
interventional
607
1 country
22
Brief Summary
The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2014
Longer than P75 for not_applicable
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2014
CompletedFirst Posted
Study publicly available on registry
August 21, 2014
CompletedStudy Start
First participant enrolled
October 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedResults Posted
Study results publicly available
September 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedJune 6, 2025
October 1, 2024
7.2 years
August 15, 2014
June 27, 2023
May 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline
Demonstration of 50% reduction in a Numerical Rating Scale (NRS; 0-10 Scale; with 10 being the highest pain imaginable) pain score from pre-treatment to post-treatment for more than 50% of all pain episodes. 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 treatment).
Randomized Testing Window (Month-1 to Month-3 post implant, 2 Month duration)
Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events
Incidence of all serious adverse events including serious adverse device events and unanticipated adverse device events.
From screening injection visit through 3 months post implant
Secondary Outcomes (6)
Secondary Effectiveness: Pain Relief After 2 Hours
12 months post implant
Secondary Effectiveness: Pain Medication Use
12 months post implant
Secondary Effectiveness: Pain Interference to Activities of Daily Living (ADL
12 months post implant
Secondary Effectiveness: Health-related Quality of Life (HR-QOL)
12 months post implant
Secondary Effectiveness: Patient Global Impression of Change (PGIC)
12 months post implant
- +1 more secondary outcomes
Study Arms (2)
Test Treatment
EXPERIMENTALSelf-initiated high frequency bioelectric nerve block delivered to the nerve by Altius.
Active Sham Control Treatment
ACTIVE COMPARATORSelf-initiated non-therapeutic electrical signal delivered to the nerve by Altius.
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥ 21 years old
- Unilateral amputated leg ≥ 12 months
- Chronic post amputation pain ≥ 6 months
- Pain episodes typically lasting ≥ 60 minutes
- Stable drug regimen ≥ 4 weeks
- No changes to medications or prosthesis for 3-month primary study period
You may not qualify if:
- Implanted with an active implantable medical device (i.e. pacemaker)
- Confounding source of pain that interferes with reporting of limb pain
- Uncontrolled diabetes
- Spasticity preventing full range of motion of involved side
- Extremely short stump; sits on end
- Untreated psychological condition (i.e. borderline personality)
- Condition requiring MRI studies or diathermy after device implant
- Life expectancy of less than 24 months
- Progressive neurological disease (i.e. multiple sclerosis)
- Subjects with active local or systemic infection or immunocompromised
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Arizona Pain Institute
Scottsdale, Arizona, 85258, United States
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, 72205, United States
HCA Healthcare Research Institute / St. Luke's Presbyterian
Denver, Colorado, 80218, United States
Nona Medical Arts
Orlando, Florida, 32827, United States
Emory University / Grady Hospital
Atlanta, Georgia, 30303, United States
Legacy Brain & Spine LLC
Atlanta, Georgia, 30339, United States
Drug Studies America
Marietta, Georgia, 30060, United States
University of Illinois Chicago
Chicago, Illinois, 60612, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Cleveland Clinic Pain Management
Cleveland, Ohio, 44106, United States
Meta Medical Research Institute
Dayton, Ohio, 45432, United States
Kettering Medical Center
Springboro, Ohio, 45066, United States
Advanced Surgical and Research Solutions
Oklahoma City, Oklahoma, 73134, United States
Cardiovascular Surgery Clinic
Memphis, Tennessee, 38120, United States
The Surgical Clinic
Nashville, Tennessee, 37203, United States
Baylor Scott and White Research Institute
Dallas, Texas, 75201, United States
Baylor Scott and White - Temple Memorial Vascular Surgery
Temple, Texas, 76508, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Related Publications (4)
Soin A, Shah NS, Fang ZP. High-frequency electrical nerve block for postamputation pain: a pilot study. Neuromodulation. 2015 Apr;18(3):197-205; discussion 205-6. doi: 10.1111/ner.12266. Epub 2015 Feb 5.
PMID: 25655583BACKGROUNDKapural L, Syed Shah N, Fang ZP, Mekhail N. Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). J Pain Res. 2022 Jun 3;15:1623-1631. doi: 10.2147/JPR.S353674. eCollection 2022.
PMID: 35685299BACKGROUNDKapural L, Melton J, Kim B, Mehta P, Sigdel A, Bautista A, Petersen EA, Slavin KV, Eidt J, Wu J, Elshihabi S, Schwalb JM, Garrett HE Jr, Veizi E, Barolat G, Rajani RR, Rhee PC, Guirguis M, Mekhail N. 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. J Pain Res. 2024 Jun 6;17:2001-2014. doi: 10.2147/JPR.S463727. eCollection 2024.
PMID: 38860215RESULTKapural L, Kim B, Eidt J, Petersen EA, Schwalb JM, Slavin KV, Mekhail N. Long-Term Treatment of Chronic Postamputation Pain With Bioelectric Nerve Block: Twelve-Month Results of the Randomized, Double-Blinded, Cross-Over QUEST Study. Neuromodulation. 2024 Dec;27(8):1383-1392. doi: 10.1016/j.neurom.2024.08.010. Epub 2024 Sep 24.
PMID: 39320284RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
A single-cross-over design (and not double-- cross-over) prohibited further evaluation of duration of therapy effectiveness after removal of therapy. While interesting, this would not have been in the best interests of the trial patients who required therapy to treat their chronic amputation pain.
Results Point of Contact
- Title
- Nick Hargus, PhD. Vice President of Clinical and Medical Affairs
- Organization
- Neuros Medical, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Leonardo Kapural, MD, PhD
Center for Clinical Research, Winston-Salem NC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2014
First Posted
August 21, 2014
Study Start
October 9, 2014
Primary Completion
December 31, 2021
Study Completion
September 1, 2025
Last Updated
June 6, 2025
Results First Posted
September 11, 2023
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share