N/A
N=18
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 3)
Pain Management
Bottom Line
View on ClinicalTrials.gov: NCT04751526 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Average Change in Pain as Measured by the Visual Analog Scale (VAS) — 1.38; 0.93 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BreEStim 240 (Device); EStim 240 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Change in Pain as Measured by the Visual Analog Scale (VAS) |
1.38; 0.93 | — |
| SECONDARY Average Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Detection Threshold (EST) |
-0.22; -0.11 | — |
| SECONDARY Average Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection Threshold (EPT) |
3.69; 0.99 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.)
Exclusion Criteria
- 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;
- are not medically stable;
- have preexisting psychiatric disorders;
- alcohol or drug abuse;
- have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants.
Data sourced from ClinicalTrials.gov (NCT04751526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.