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Behavioural Intervention

BreEStim for Pain Management

N/A
Recruiting
Led By Sheng Li, MD, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
has phantom limb pain (PLP) after amputation of one limb, upper or lower limb;
has chronic pain, >3 months;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 5 minutes after intervention
Awards & highlights

Study Summary

This trial will compare two electrical stimulations for phantom limb pain after amputation.

Who is the study for?
This trial is for individuals who have phantom limb pain (PLP) following the amputation of one limb, either upper or lower. Participants should have had chronic pain for over three months and be stable on their current oral pain medications with no changes in the past two weeks. It's not suitable for those with cognitive impairments, unstable medical conditions, psychiatric disorders, substance abuse issues, pacemakers/metal implants, multiple limb amputations, non-PLP related pain at the incision site, recent medication adjustments for PLP, pulmonary diseases or a history of seizures.Check my eligibility
What is being tested?
The study aims to compare two treatments: breathing controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim), to see which is more effective in managing neuropathic phantom limb pain after an amputation.See study design
What are the potential side effects?
While specific side effects are not listed for BreEStim and EStim in this summary information provided about the clinical trial; generally speaking these types of interventions may cause discomfort at the site of application or skin irritation. Rarely they might induce muscle twitching or exacerbate existing symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I experience phantom limb pain after losing a limb.
Select...
I have been experiencing pain for more than 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 5 minutes after intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 5 minutes after intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Heart Rate Variability (HRV) measured by electrocardiogram (ECG)
Change in Pain as measured by the visual analog scale (VAS). Scores are recorded from 0 to10.
Change in pain measured by Electrical pain detection threshold (EPT)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: EStim 120, then BreEStim 120Experimental Treatment2 Interventions
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. EStim is transcutaneous electrical nerve stimulation.
Group II: BreEStim 120, then EStim 120Experimental Treatment2 Interventions
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. EStim is transcutaneous electrical nerve stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BreEStim
2015
N/A
~20

Find a Location

Who is running the clinical trial?

National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
71 Previous Clinical Trials
9,115 Total Patients Enrolled
2 Trials studying Pain Management
40 Patients Enrolled for Pain Management
The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
321,010 Total Patients Enrolled
4 Trials studying Pain Management
58 Patients Enrolled for Pain Management
Sheng Li, MD, PhD4.896 ReviewsPrincipal Investigator - The University of Texas Health Science Center, Houston
Swedish Medical Center / First Hill Campus, Swedish Medical Center / Cherry Hill Campus, Swedish Medical Center / Issaquah Campus
Medical School - Rosalind Franklin University of Medicine and Science, Doctor of Medicine
Louisiana State University, Residency in Ophthalmology
8 Previous Clinical Trials
87 Total Patients Enrolled
4 Trials studying Pain Management
58 Patients Enrolled for Pain Management
5Patient Review
Dr. Chen was extremely amicable and forthcoming with answers to my questions. The staff were very hospitable too. I would recommend this dentist to anyone.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor actively seeking participants at the present time?

"This clinical trial is actively seeking enrollees, with the initial posting on April 2nd 2021 and most recent update occurring on April 23rd 2022. This information can be found in detail at clinicaltrials.gov."

Answered by AI

How many participants has the research group enlisted for this trial?

"Affirmative. Per the information posted on clinicaltrials.gov, this experiment is still in search of participants and was first published on April 2nd 2021 with its latest update occurring on April 23rd 2022. The researchers are currently looking for 14 individuals across one medical centre to partake in the study."

Answered by AI

How may I apply to be part of this research initiative?

"This clinical trial is seeking 14 participants who are aged between 18 and 75, and have suffered from chronic pain that has lasted for more than three months. Additionally, they must be experiencing phantom limb pain after amputation of an upper or lower extremity without having made any alterations to their current oral medication regimen in the past two weeks."

Answered by AI

Does this trial offer participation to any individuals younger than 75 years old?

"According to the study's criteria, only individuals aged 18 - 75 are eligible for participation. Additionally, there are two separate studies available targeting minors and 52 trials developed specifically with seniors in mind."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
The University of Texas Health Science Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. The University of Texas Health Science Center: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 1)
Sheng Li 2021. "A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04750525.
~3 spots leftby Apr 2025
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