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A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 3)

NCT04751526 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-03-20

Study results available
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Summary

The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) in management of neuropathic phantom limb pain in patients after limb amputation after multiple sessions of treatment.

Conditions

  • Pain Management

Interventions

DEVICE

BreEStim 240

240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.

DEVICE

EStim 240

240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.

Sponsors & Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

    collaborator FED

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Sheng Li, MD, PhD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-02
Primary Completion
2024-02-22
Completion
2024-02-22
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04751526 on ClinicalTrials.gov