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NCT03484429 · ClinicalTrials.gov registry record · NA

Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain

A NA study, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center.

Completed
Registry status
NA
Development phase
16
Enrollment target

NCT03484429: Completed NA study, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center.

NCT03484429 is a NA study that has completed, run by Hunter Holmes Mcguire Veteran Affairs Medical Center. The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03484429, a NA study, has completed, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center.

COMPLETED
Registry status
NA
Development phase
16 participants
Enrollment target

Study 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.

Primary Outcome

Using the Brief Pain Inventory-Short Form (BPI-SF) questionnaire, subjects were asked to rate their PLP over the past 24 hours on a scale of "0"=no pain to "10"=worst pain they have ever experienced. A lower score is better. Data from Weeks 1-4 and Weeks 5-8 were averaged to obtain a numerical score for these time points.

Interventions

  • DEVICE Peripheral nerve stimulation
  • OTHER Standard Medical Therapy

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2017-12-01
Est. Completion 2021-04-17
Phase NA

What the finished NCT03484429 record still lists

NCT03484429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Peripheral nerve stimulation is the first listed.

NCT03484429 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03484429 about?

NCT03484429 is a clinical study titled "Postoperative Peripheral Nerve Stimulation for Management of Post-amputation Pain". 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 result...

What is the current status of trial NCT03484429?

This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2017-12-01. Estimated completion is 2021-04-17.

What interventions are being tested in trial NCT03484429?

The interventions under investigation include: Peripheral nerve stimulation (DEVICE), Standard Medical Therapy (OTHER).

Who is sponsoring clinical trial NCT03484429?

This trial is sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center, which has 27 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03484429's enrollment target sits among peer trials

16 1871st of 2000 higher than 120 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03484429, the US trial registry maintained by the National Library of Medicine. NCT03484429 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.