Pain ManagementNCT04751526
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 3)
A study testing BreEStim 240 and EStim 240 in people with Pain Management, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 after multiple sessions of treatment. 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 240 and EStim 240
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2021to 22 Feb 2024
- 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;
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- 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
About this study
Official title: A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation
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 after multiple sessions of treatment.
Read the detailed description
Subjects will receive 10-session BreEStim and 10-session EStim treatment in a random order. The interval between BreEStim and EStim is at least 2 weeks. The following assessment will be made before and after
- Visual analogue scale (VAS).
- Quantitative sensory testing (QST). It includes non-invasive assessment of tactile sensation threshold (TST), electrical sensation threshold (EST), electrical pain threshold (EPT), and thermal thresholds.
- Hear rate variability (HRV). It consists of 5-minute electrocardiogram (ECG) recording before and after a treatment session.
- Conditions
- Pain Management
- Being tested
- BreEStim 240, EStim 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 240Device
240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
EStim 240Device
240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
| Study group | Role | What they receive |
|---|---|---|
| BreEStim 240, then EStim 240 | Experimental | BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. Receives: Device: BreEStim 240; Device: EStim 240 |
| EStim 240, then BreEstim 240 | Experimental | EStim is transcutaneous electrical nerve stimulation. Receives: Device: BreEStim 240; Device: EStim 240 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Change in Pain 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. For each session change is reported as [(VAS score at baseline) - (VAS Score 10 minutes after each intervention)] - a positive value indicates that the score (and pain level) decreased. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10.
Measured: From Baseline to completion of 10 intervention sessions (about 2 weeks)
Secondary outcomes (2)
Average Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Detection 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.
For each session change is reported is reported as [(EST at 5 minutes after intervention) - (EST at baseline)] - a positive value indicates a decrease in sensation perception. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10.
Measured: From Baseline to completion of 10 intervention sessions (about 2 weeks)
Average 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. For each session change is reported as [(EPT at 5 minutes after intervention) - (EPT at baseline)] - a positive value indicates an increase in pain threshold. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10.
Measured: From Baseline to completion of 10 intervention sessions (about 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start2 Apr 2021
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
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
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Sheng Li, The University of Texas Health Science Center, Houston
- Investigators
- Sheng Li, MD, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751526
- Sponsor's protocol ID
- HSC-MS-20-1032 (Experiment 3)
- 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
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
- NCT04751526
- Acronym / sponsor ID
- HSC-MS-20-1032 (Experiment 3)
- Conditions
- Pain Management
- Keywords
- Phantom Limb Pain, BreEStim
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 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
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 12 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.
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 after multiple sessions of treatment.
Detailed description
Subjects will receive 10-session BreEStim and 10-session EStim treatment in a random order. The interval between BreEStim and EStim is at least 2 weeks. The following assessment will be made before and after
- Visual analogue scale (VAS).
- Quantitative sensory testing (QST). It includes non-invasive assessment of tactile sensation threshold (TST), electrical sensation threshold (EST), electrical pain threshold (EPT), and thermal thresholds.
- Hear rate variability (HRV). It consists of 5-minute electrocardiogram (ECG) recording before and after a treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BreEStim 240, then EStim 240 | Experimental | Device: BreEStim 240, Device: EStim 240BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. |
| EStim 240, then BreEstim 240 | Experimental | Device: BreEStim 240, Device: EStim 240EStim is transcutaneous electrical nerve stimulation. |
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 240240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect. | Device | BreEStim 240, then EStim 240, EStim 240, then BreEstim 240 |
| EStim 240240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect. | Device | BreEStim 240, then EStim 240, EStim 240, then BreEstim 240 |
Primary outcome
Average Change in Pain as Measured by the Visual Analog Scale (VAS)
Time frame: From Baseline to completion of 10 intervention sessions (about 2 weeks)
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. For each session change is reported as [(VAS score at baseline) - (VAS Score 10 minutes after each intervention)] - a positive value indicates that the score (and pain level) decreased. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10.
2 secondary outcomes
Average Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Detection Threshold (EST)
Time frame: From Baseline to completion of 10 intervention sessions (about 2 weeks)
Average Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection Threshold (EPT)
Time frame: From Baseline to completion of 10 intervention sessions (about 2 weeks)
Results and safety
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 240 and EStim 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?
Average Change in Pain as Measured by the Visual Analog Scale (VAS) (time frame: From Baseline to completion of 10 intervention sessions (about 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.