A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 1)
NCT ID: NCT04750525
Last Updated: 2025-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2021-04-02
2023-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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BreEStim 120, then EStim 120
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. EStim is transcutaneous electrical nerve stimulation.
BreEStim
120 BreEStim stimuli will applied for about 10-30 minutes.
EStim
120 EStim stimuli will applied for about 10-30 minutes.
EStim 120, then BreEStim 120
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. EStim is transcutaneous electrical nerve stimulation.
BreEStim
120 BreEStim stimuli will applied for about 10-30 minutes.
EStim
120 EStim stimuli will applied for about 10-30 minutes.
Interventions
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BreEStim
120 BreEStim stimuli will applied for about 10-30 minutes.
EStim
120 EStim stimuli will applied for about 10-30 minutes.
Eligibility Criteria
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Inclusion Criteria
* 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.)
Exclusion Criteria
* 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;
* are not medically stable;
* have preexisting psychiatric disorders;
* alcohol or drug abuse;
* have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.
18 Years
75 Years
ALL
No
Sponsors
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National Institute on Disability, Independent Living, and Rehabilitation Research
FED
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Sheng Li
Professor
Principal Investigators
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Sheng Li, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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HSC-MS-20-1032 (Experiment 1)
Identifier Type: -
Identifier Source: org_study_id
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