Electrical Nerve Block for Amputation Pain
Active, not recruitingNot applicableNCT02221934
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study
- Conditions
- Post-Amputation Pain
- Phantom Limb Pain
- Residual Limb Pain
- Stump Pain
- Interventions
- Device: Altius
- Sponsor
- Neuros Medical, Inc.
- Start date
- 2014-10-09
- Primary completion
- 2021-12-31
- Sex
- All
- Age range
- from 21 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 22
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02221934