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Behavioural Intervention

BreEStim 240 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 chronic pain, >3 months

Has phantom limb pain (PLP) after amputation of one limb, upper or lower limb

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, after 10 intervention sessions, about 2 weeks

Awards & highlights

Study Summary

This trial compares two electrical stimulation treatments for neuropathic phantom limb pain.

Who is the study for?

This trial is for individuals with phantom limb pain (PLP) following the amputation of one limb, who have been stable on oral pain medications for at least two weeks. It's not suitable for those adjusting their pain meds, with metal implants or pacemakers, cognitive impairments, unstable medical conditions, psychiatric disorders, substance abuse issues, multiple amputations or certain chronic diseases.Check my eligibility

What is being tested?

The study compares BreEStim—a breathing controlled electrical stimulation—and conventional EStim to see which is more effective in managing neuropathic PLP after limb amputation. Participants will undergo multiple treatment sessions to assess the interventions' effectiveness.See study design

What are the potential side effects?

While specific side effects are not listed for BreEStim and EStim in this summary, electrical stimulation can sometimes cause skin irritation at the site of application and muscle twitching during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been experiencing pain for more than 3 months.

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I experience phantom limb pain after losing a limb.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, after 10 intervention sessions, about 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, after 10 intervention sessions, about 2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after 10 intervention sessions, about 2 weeks 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: EStimExperimental Treatment1 Intervention

EStim is transcutaneous electrical nerve stimulation.

Group II: BreEStimExperimental Treatment1 Intervention

BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

903 Previous Clinical Trials

320,953 Total Patients Enrolled

4 Trials studying Pain Management

48 Patients Enrolled for Pain Management

National Institute on Disability, Independent Living, and Rehabilitation ResearchFED

71 Previous Clinical Trials

9,105 Total Patients Enrolled

2 Trials studying Pain Management

30 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

77 Total Patients Enrolled

4 Trials studying Pain Management

48 Patients Enrolled for Pain Management

4Patient Review

I appreciated the thoroughness of the doctor and his associate during my examination.

Frequently Asked Questions

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

Does this clinical investigation accept participants who are aged 65 or more?

"As per the outlined parameters for inclusion, individuals aged 18 or above but no older than 75 can take part in this study."

Answered by AI

How many individuals are engaged in this research endeavor?

"Verified. Clinicaltrials.gov provides evidence that recruitment for this medical research has been underway since April 2nd 2021, and was last modified on May 21st of the same year. The experiment seeks to enlist 24 patients from a single site."

Answered by AI

Is enrollment still open for this research endeavor?

"Based on the listings available through clinicaltrials.gov, this study is still recruiting participants. It was originally posted on April 2nd 2021 and the listing has been recently updated as of May 21st 2021."

Answered by AI

Am I eligible to take part in this experimental research?

"To be eligible for this medical trial, patients must fulfill the following criteria: ages 18 to 75; currently suffering from chronic pain (>3 months); have phantom limb pain (PLP) after amputation of one limb, upper or lower; and remain stable on their current oral pain medications for two weeks."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Sheng Li 2021. "A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 3)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04751526.