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

The University of Texas System (UT)

Status: Completed

Conditions: Pain Management

Treatments: Device: BreEStim 120; Device: BreEStim 240

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04750538

HSC-MS-20-1032 (Experiment 2)

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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17 participants in 2 patient groups

BreEStim 120, then BreEStim 240

Experimental group

Description:

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.

Treatment:

Device: BreEStim 240

Device: BreEStim 120

BreEStim 240, then BreEStim 120

Experimental group

Description:

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.

Treatment:

Device: BreEStim 240

Device: BreEStim 120