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

NCT04750525 | Completed Results FDA Device

• 1 other identifier: HSC-MS-20-1032 (Experiment 1)
• Study Type: interventional
• Target: 15
• 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.

Conditions

Pain Management

Keywords

Phantom Limb Pain; BreEStim

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 10 minutes after intervention

Secondary Outcomes (2)

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

  Baseline, 5 minutes after intervention

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

  Baseline, 5 minutes after intervention

Other Outcomes (1)

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

  Baseline, 10 minutes after intervention

Study Arms (2)

BreEStim 120, then EStim 120

EXPERIMENTAL

BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. EStim is transcutaneous electrical nerve stimulation.

Device: BreEStim; Device: EStim

EStim 120, then BreEStim 120

EXPERIMENTAL

BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. EStim is transcutaneous electrical nerve stimulation.

Device: BreEStim; Device: EStim

Interventions

BreEStim DEVICE

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

BreEStim 120, then EStim 120; EStim 120, then BreEStim 120

EStim DEVICE

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

BreEStim 120, then EStim 120; EStim 120, then BreEStim 120

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: NON 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 11, 2021
• Study Start: April 2, 2021
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)