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A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 2) | Clinical Trials | Clareo Health

COMPLETEDNA

A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 2)

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

NCT04750538•The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•has phantom limb pain (PLP) after amputation of one limb, upper or lower limb;
•has chronic pain, \>3 months;
•is stable on oral pain medications at least two weeks. (patients are allowed to continue their pain medications, i.e., no change in pain medications.)

Exclusion Criteria

•currently adjusting oral pain medications for their PLP;
•has pain, but not PLP (e.g., from inflammation at the incision wound of the residual limb);
•has a pacemaker, or other metal and/or implanted devices;
•has cognitive impairment from brain injury or are not able to follow commands, or to give consent;
•has amputation in multiple limbs;
•have asthma or other pulmonary diseases;
•are not medically stable;
•have preexisting psychiatric disorders;
•alcohol or drug abuse;
•have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.

Locations (1)

The University of Texas Health Science Center

Houston, Texas, United States

Key Dates

Start Date

April 2, 2021

Primary Completion Date

May 19, 2023

Completion Date

May 19, 2023

Last Updated

March 20, 2025

Enrollment

ACTUAL participants

Conditions

Pain Management

Interventions

BreEStim 120

DEVICE

BreEStim 240

DEVICE

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 2)

Inclusion Criteria

Exclusion Criteria

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