A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 3)

The University of Texas System (UT)

Status: Completed

Conditions: Pain Management

Treatments: Device: BreEStim 240; Device: EStim 240

Study type: Interventional

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

Identifiers

NCT04751526

HSC-MS-20-1032 (Experiment 3)

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 after multiple sessions of treatment.

Full 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

1. Visual analogue scale (VAS).
2. 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.
3. Hear rate variability (HRV). It consists of 5-minute electrocardiogram (ECG) recording before and after a treatment session.

Enrollment: 18 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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18 participants in 2 patient groups

BreEStim 240, then EStim 240

Experimental group

Description:

BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.

Treatment:

Device: EStim 240

Device: BreEStim 240

EStim 240, then BreEstim 240

Experimental group

Description:

EStim is transcutaneous electrical nerve stimulation.

Treatment:

Device: EStim 240

Device: BreEStim 240