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

Not Applicable

Completed

Conditions: Pain Management

Interventions: Device: EStim 240
Device: BreEStim 240

Registration Number: NCT04751526

Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 18

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
EStim	EStim 240	EStim is transcutaneous electrical nerve stimulation.
BreEStim	BreEStim 240	BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.

Primary Outcome Measures

Name	Time	Method
Average Change in Pain as Measured by the Visual Analog Scale (VAS)	From Baseline to completion of 10 intervention sessions (about 2 weeks)	VAS Scores are recorded from 0 to 10 with 0 being "no pain" and 10 being "worst pain", a higher score indicating a higher level of pain. For each session change is reported as \[(VAS score at baseline) - (VAS Score 10 minutes after each intervention)\] - a positive value indicates that the score (and pain level) decreased. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10.

Secondary Outcome Measures

Name	Time	Method
Average Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Detection Threshold (EST)	From Baseline to completion of 10 intervention sessions (about 2 weeks)	Electrical Sensation Threshold (EST) is the minimum electrical current intensity that a person can reliably perceive as a sensation on their skin. This threshold is self-reported by the subjects, and electrical intensity values are recorded when participants first detect the electrical stimulation. For each session change is reported is reported as \[(EST at 5 minutes after intervention) - (EST at baseline)\] - a positive value indicates a decrease in sensation perception. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10.
Average Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection Threshold (EPT)	From Baseline to completion of 10 intervention sessions (about 2 weeks)	An Electrical Pain Threshold (EPT) refers to the minimum intensity of electrical stimulation required to produce a perceptible pain sensation on a person's skin, essentially measuring the point at which an electrical current becomes painful. The EPT is self-reported by subjects when they feel the electrical intensity begins to cause pain. For each session change is reported as \[(EPT at 5 minutes after intervention) - (EPT at baseline)\] - a positive value indicates an increase in pain threshold. For this outcome measure we report the average change over all 10 sessions which is calculated by the sum of all divided by 10.