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NCT Number: NCT04751526

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

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.

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Key information

Conditions

Pain Management Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center

Houston, Texas, 77030, United States

About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BreEStim 240

Device

240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.

EStim 240

Device

240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Average Change in Sensation Threshold on Amputated Limb Measured by Electrical Sensation Detection Threshold (EST)

    Time frame: 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.

  2. Average Change in Pain Threshold on Amputated Limb Measured by Electrical Pain Detection Threshold (EPT)

    Time frame: 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.

Other outcomes

  1. Change in Heart Rate Variability (HRV) Measured by Electrocardiogram (ECG)

    Time frame: Baseline, after 10 intervention sessions, about 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2021
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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