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

Primary Purpose

Pain Management

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BreEStim
EStim
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Management focused on measuring Phantom Limb Pain, BreEStim

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Texas Health Science CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

BreEStim 120, then EStim 120

EStim 120, then BreEStim 120

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Pain as measured by the visual analog scale (VAS). Scores are recorded from 0 to10.
Scores are recorded from 0 to 10 with 0 being "no pain" and 10 being "worst pain."
Change in sensation measured by Electrical sensation detection threshold (EDT)
This is self-reported by the subjects as soon as they first sense the electrical current.
Change in pain measured by Electrical pain detection threshold (EPT)
This is self-reported by the subjects at the first sensation of pain.
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.

Secondary Outcome Measures

Full Information

First Posted
February 10, 2021
Last Updated
May 10, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research
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1. Study Identification

Unique Protocol Identification Number
NCT04750525
Brief Title
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 1)
Official Title
A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 1)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2021 (Actual)
Primary Completion Date
August 21, 2023 (Anticipated)
Study Completion Date
August 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Management
Keywords
Phantom Limb Pain, BreEStim

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BreEStim 120, then EStim 120
Arm Type
Experimental
Arm Description
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. EStim is transcutaneous electrical nerve stimulation.
Arm Title
EStim 120, then BreEStim 120
Arm Type
Experimental
Arm Description
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. EStim is transcutaneous electrical nerve stimulation.
Intervention Type
Device
Intervention Name(s)
BreEStim
Intervention Description
120 BreEStim stimuli will applied for about 10 minutes.
Intervention Type
Device
Intervention Name(s)
EStim
Intervention Description
120 EStim stimuli will applied for about 10 minutes.
Primary Outcome Measure Information:
Title
Change in Pain as measured by the visual analog scale (VAS). Scores are recorded from 0 to10.
Description
Scores are recorded from 0 to 10 with 0 being "no pain" and 10 being "worst pain."
Time Frame
Baseline, 5 minutes after intervention
Title
Change in sensation measured by Electrical sensation detection threshold (EDT)
Description
This is self-reported by the subjects as soon as they first sense the electrical current.
Time Frame
Baseline, 5 minutes after intervention
Title
Change in pain measured by Electrical pain detection threshold (EPT)
Description
This is self-reported by the subjects at the first sensation of pain.
Time Frame
Baseline, 5 minutes after intervention
Title
Change in Heart Rate Variability (HRV) measured by electrocardiogram (ECG)
Description
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.
Time Frame
Baseline, 5 minutes after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng Li, MD, PhD
Phone
(713) 797-7125
Email
sheng.li@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shengai Li, MS
Phone
713-797-7561
Email
shengai.li@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng Li, MD, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengai Li, MD, PhD
Phone
713-797-7125
Email
sheng.li@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Shengai Li, MS
Phone
(713)797-7561
Email
shengai.li@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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