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Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

NCT03484429 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-07-21

Study results available
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Summary

Limb loss is frequently associated with postamputation pain that can be challenging to treat and often involves opioids. Advances in the field of neuromodulation has led to development of an intentionally reversible percutaneous peripheral nerve stimulation (PNS) system that has had promising results when treating chronic postamputation pain. PNS may offer sustained pain relief even after the treatment period has ended. Currently, there is no convincing evidence regarding the role of PNS in the acute postoperative period, which may be a critical time to control pain as those with higher pain appear to be at higher risk for developing persistent post-procedural pain. The investigators of this study aim to evaluate the feasibility and effects of PNS in the acute postoperative period and determine the feasibility of completing a randomized controlled treatment outcome study.

Conditions

  • Phantom Limb Pain
  • Postoperative Pain
  • Neuroma
  • Acute Pain
  • Chronic Pain
  • Residual Limbs
  • Amputation

Interventions

DEVICE

Peripheral nerve stimulation

Up to 60 days of peripheral nerve stimulation

OTHER

Standard Medical Therapy

Medications, physical therapy, or other pain treatments

Sponsors & Collaborators

  • Hunter Holmes Mcguire Veteran Affairs Medical Center

    lead FED

Principal Investigators

  • Denise Lester, MD · Hunter Holmes McGuire VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2021-04-17
Completion
2021-04-17
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03484429 on ClinicalTrials.gov