Pain ManagementNCT04750538

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

A study testing BreEStim 120 and BreEStim 240 in people with Pain Management, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pain Management
What is being tested?: BreEStim 120 and BreEStim 240
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 2 Apr 2021to 19 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.)

Who cannot join

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;

Show all 10Show fewer

are not medically stable;
have preexisting psychiatric disorders;
alcohol or drug abuse;
have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center
Houston, Texas, 77030

Other trials in United States

About this study

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

Conditions: Pain Management
Being tested: BreEStim 120, BreEStim 240
Keywords: Phantom Limb Pain, BreEStim
Medical subject headings: Agnosia, Phantom Limb

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BreEStim 120Device
120 BreEStim stimuli will applied for about 10-15 minutes.
BreEStim 240Device
240 BreEStim stimuli will applied for about 20-30 minutes.

Study groups in NCT04750538
Study group	Role	What they receive
BreEStim 120, then BreEStim 240	Experimental	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. Receives: Device: BreEStim 120; Device: BreEStim 240
BreEStim 240, then BreEStim 120	Experimental	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. Receives: Device: BreEStim 120; Device: BreEStim 240

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Pain Level as Measured by the Visual Analog Scale (VAS).
VAS Scores are recorded from 0 to 10 with 0 being "no pain" and 10 being "worst pain", a higher score indicating a higher level of pain. Change is reported as [(VAS score at baseline) - (VAS Score 10 minutes after intervention)] - a positive value indicates that the score (and pain level) decreased
Measured: Baseline, 10 minutes after intervention

Secondary outcomes (2)

Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Threshold (EST)
Electrical Sensation Threshold (EST) is the minimum electrical current intensity that a person can reliably perceive as a sensation on their skin. This threshold is self-reported by the subjects, and electrical intensity values are recorded when participants first detect the electrical stimulation. Change is reported as [(EST at 5 minutes after intervention) - (EST at baseline)] - a positive value indicates a decrease in sensation perception.
Measured: Baseline, 5 minutes after intervention
Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection Threshold (EPT)
An Electrical Pain Threshold (EPT) refers to the minimum intensity of electrical stimulation required to produce a perceptible pain sensation on a person's skin, essentially measuring the point at which an electrical current becomes painful. The EPT is self-reported by subjects when they feel the electrical intensity begins to cause pain. Change is reported as [(EPT at 5 minutes after intervention) - (EPT at baseline)] - a positive value indicates an increase in pain threshold.
Measured: Baseline, 5 minutes after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Apr 202119 May 2023

First posted11 Feb 2021
Study start2 Apr 2021
Primary completion19 May 2023
Study completion19 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pain ManagementStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04750538
Sponsor's protocol ID: HSC-MS-20-1032 (Experiment 2)
Status last verified: Mar 2025
First submitted: 10 Feb 2021
Last updated: 20 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation
ClinicalTrials.gov ID: NCT04750538
Acronym / sponsor ID: HSC-MS-20-1032 (Experiment 2)
Conditions: Pain Management
Keywords: Phantom Limb Pain, BreEStim
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
Study start: 2 Apr 2021 (actual)
Primary completion: 19 May 2023 (actual)
Study completion: 19 May 2023 (actual)
First posted: 11 Feb 2021 (actual)
Results: Posted 20 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
BreEStim 120, then BreEStim 240	Experimental	Device: BreEStim 120, Device: BreEStim 240BreEStim 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.
BreEStim 240, then BreEStim 120	Experimental	Device: BreEStim 120, Device: BreEStim 240BreEStim 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.)

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BreEStim 120120 BreEStim stimuli will applied for about 10-15 minutes.	Device	BreEStim 120, then BreEStim 240, BreEStim 240, then BreEStim 120
BreEStim 240240 BreEStim stimuli will applied for about 20-30 minutes.	Device	BreEStim 120, then BreEStim 240, BreEStim 240, then BreEStim 120

Primary outcome

Change in Pain Level as Measured by the Visual Analog Scale (VAS).
Time frame: Baseline, 10 minutes after intervention
VAS Scores are recorded from 0 to 10 with 0 being "no pain" and 10 being "worst pain", a higher score indicating a higher level of pain. Change is reported as [(VAS score at baseline) - (VAS Score 10 minutes after intervention)] - a positive value indicates that the score (and pain level) decreased

2 secondary outcomes

Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Threshold (EST)
Time frame: Baseline, 5 minutes after intervention
Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection Threshold (EPT)
Time frame: Baseline, 5 minutes after intervention

Results and safety

Results posted to the registry on 20 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BreEStim 120, Then BreEStim 240	17	17
BreEStim 240, Then BreEStim 120	0	0

Primary outcome: Change in Pain Level as Measured by the Visual Analog Scale (VAS).

Time frame: Baseline, 10 minutes after intervention. Mean (Standard Deviation). Unit: score on a scale

Measure	BreEStim 120 n = 17	BreEStim 240 n = 17
Value	1.43 (1.24)	1.71 (1.39)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BreEStim 120	0 of 17 (0%)	17 of 17 (100%)	0 of 17
BreEStim 240	0 of 17 (0%)	17 of 17 (100%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sheng Li, MD, PhD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BreEStim 120 and BreEStim 240 in people with Pain Management, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Level as Measured by the Visual Analog Scale (VAS). (time frame: Baseline, 10 minutes after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04750538.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.