← Back to Search

Behavioural Intervention

BreEStim 120 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 5 minutes after intervention

Awards & highlights

Study Summary

This trial will compare two electrical stimulation treatments for phantom limb pain in amputees.

Who is the study for?

This trial is for individuals with chronic phantom limb pain (PLP) lasting more than 3 months after losing one limb. They must be stable on their current oral pain medications for at least two weeks and can continue them during the trial. It's not suitable for those without PLP, with pacemakers or metal implants, cognitive impairments, multiple amputations, unstable medical conditions, pulmonary diseases, psychiatric disorders, substance abuse issues, seizure history or those adjusting pain meds.Check my eligibility

What is being tested?

The study aims to compare a new method called breathing controlled electrical stimulation (BreEStim) against conventional electrical stimulation (EStim) in managing neuropathic phantom limb pain post-amputation. Participants will receive either BreEStim at different intensities (120 or 240) or EStim to see which is more effective.See study design

What are the potential side effects?

While specific side effects are not listed for BreEStim and EStim in this summary, these treatments may cause discomfort at the site of application. There could also be potential skin irritation from electrode placement and muscle soreness similar to that experienced after mild exercise.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 5 minutes after intervention

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: BreEStim 240, then BreEStim 120Experimental Treatment2 Interventions

BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment.

Group II: BreEStim 120, then BreEStim 240Experimental Treatment2 Interventions

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

903 Previous Clinical Trials

320,961 Total Patients Enrolled

4 Trials studying Pain Management

56 Patients Enrolled for Pain Management

National Institute on Disability, Independent Living, and Rehabilitation ResearchFED

71 Previous Clinical Trials

9,113 Total Patients Enrolled

2 Trials studying Pain Management

38 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

85 Total Patients Enrolled

4 Trials studying Pain Management

56 Patients Enrolled for Pain Management

4Patient Review

I appreciated the time taken to examine my eyes in detail. The doctor and his associate were both very professional.

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 open to adults aged eighteen and above?

"Patients hoping to be part of this medical trial must between 18 and 75 years old. For those younger or older, there are two separate studies: one for individuals under 18, the other for those above 65."

Answered by AI

How many participants is the clinical trial currently comprised of?

"Affirmative. According to the data hosted on clinicaltrials.gov, this scientific investigation is actively searching for participants and was originally posted on April 2nd 2021 before being updated lastly on April 23rd 2022. The research team needs 16 individuals at a single site."

Answered by AI

Are there currently any vacancies for this medical experiment?

"Correct. The clinical trial is actively seeking participants, as evidenced by its presence on the website clinicaltrials.gov. It was first posted on April 2nd 2021 and it's most recent update came just last month, with 16 individuals needed across a single medical site."

Answered by AI

Who is eligible to enroll in this research endeavor?

"This study requires 16 participants aged 18 to 75, who have experienced long-term pain management. In addition, they should demonstrate a history of phantom limb pain following amputation and be taking stable oral medications for at least two weeks prior to enrollment. (No changes in these prescriptions are allowed during the trial.)"

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 2)

Sheng Li 2021. "A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04750538.