N/A N=15 Single-blind Treatment

A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 1)

Pain Management

Bottom Line

View on ClinicalTrials.gov: NCT04750525 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Change in Pain Level as Measured by the Visual Analog Scale (VAS). — 1.38; 1.27 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: BreEStim (Device); EStim (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Mar 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pain Level as Measured by the Visual Analog Scale (VAS).	1.38; 1.27	—
SECONDARY Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Threshold (EST)	1.00; 0.44	—
SECONDARY Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Threshold (EPT)	3.99; 3.39	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04750525). 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.