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

The University of Texas Health Science Center, Houston15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pain Management

Interventions

BreEStimDEVICE

120 BreEStim stimuli will applied for about 10-30 minutes.

EStimDEVICE

120 EStim stimuli will applied for about 10-30 minutes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

The University of Texas Health Science Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Change in Pain Level as Measured by the Visual Analog Scale (VAS).

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. Change is reported as \[(VAS score at baseline) - (VAS Score 10 minutes after intervention)\] - a positive value indicates that the score (and pain level) decreased

Time frame: Baseline, 10 minutes after intervention

Secondary Outcomes

Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Threshold (EST)

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. Change is reported as \[(EST at 5 minutes after intervention) - (EST at baseline)\] - a positive value indicates a decrease in sensation perception.

Time frame: Baseline, 5 minutes after intervention

Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Threshold (EPT)

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. Change is reported as \[(EPT at 5 minutes after intervention) - (EPT at baseline)\] - a positive value indicates an increase in pain threshold.

Time frame: Baseline, 5 minutes after intervention

Data from ClinicalTrials.gov

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