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

NCT04751526 | Completed Results FDA Device

• 1 other identifier: HSC-MS-20-1032 (Experiment 3)
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management

Keywords

Phantom Limb Pain; BreEStim

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• 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)

Other Outcomes (1)

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

  Baseline, after 10 intervention sessions, about 2 weeks

Study Arms (2)

BreEStim 240, then EStim 240

EXPERIMENTAL

BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.

Device: BreEStim 240; Device: EStim 240

EStim 240, then BreEstim 240

EXPERIMENTAL

EStim is transcutaneous electrical nerve stimulation.

Device: BreEStim 240; Device: EStim 240

Interventions

BreEStim 240 DEVICE

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

BreEStim 240, then EStim 240; EStim 240, then BreEstim 240

EStim 240 DEVICE

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

BreEStim 240, then EStim 240; EStim 240, then BreEstim 240

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

The University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Agnosia; Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain

Results Point of Contact

• Title: Sheng Li, MD, PhD
• Organization: The University of Texas Health Science Center at Houston

sheng.li@uth.tmc.edu

713-797-7125

Study Officials

• Sheng Li, MD, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 12, 2021
• Study Start: April 2, 2021
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: March 20, 2025
• Results First Posted: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)