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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain Management
• Intervention / Treatment: Device: BreEStim 240; Device: EStim 240

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BreEStim 240, then EStim 240; BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.	Device: BreEStim 240; 240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.; Device: EStim 240; 240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
Experimental: EStim 240, then BreEstim 240; EStim is transcutaneous electrical nerve stimulation.	Device: BreEStim 240; 240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.; Device: EStim 240; 240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Change in Pain 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. 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.	From Baseline to completion of 10 intervention sessions (about 2 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Detection 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. 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.	From Baseline to completion of 10 intervention sessions (about 2 weeks)
Average Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection 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. 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.	From Baseline to completion of 10 intervention sessions (about 2 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Heart Rate Variability (HRV) Measured by Electrocardiogram (ECG)	HRV is a measure of the variation in time between each heartbeat. We use HRV to identify the autonomic nervous system changes after intervention treatment.	Baseline, after 10 intervention sessions, about 2 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
• Investigators: Principal Investigator: Sheng Li, MD, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2021
• Primary Completion (Actual): February 22, 2024
• Study Completion (Actual): February 22, 2024

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Phantom Limb Pain; BreEStim
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Phantom Limb
• Other Study ID Numbers: HSC-MS-20-1032 (Experiment 3)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No