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A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 2)

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ClinicalTrials.gov Identifier: NCT04750538
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : May 24, 2021
Sponsor:
Collaborator:
National Institute on Disability, Independent Living, and Rehabilitation Research
Information provided by (Responsible Party):
Sheng Li, The University of Texas Health Science Center, Houston

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Management Device: BreEStim 120 Device: BreEStim 240 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Non-invasive Intervention (BreEStim) for Management of Phantom Limb Pain (PLP) After Limb Amputation (Experiment 2)
Actual Study Start Date : April 2, 2021
Estimated Primary Completion Date : August 21, 2023
Estimated Study Completion Date : August 21, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: BreEStim 120, then BreEStim 240
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment.
 Device: BreEStim 120
120 BreEStim stimuli will applied for about 10 minutes.

Device: BreEStim 240
240 BreEStim stimuli will applied for about 20 minutes.
Experimental: BreEStim 240, then BreEStim 120
BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation. 120 vs 240 BreEStim electrical stimuli will be compared to examine the impact of different stimuli "dose" on pain reduction in this experiment.
 Device: BreEStim 120
120 BreEStim stimuli will applied for about 10 minutes.

Device: BreEStim 240
240 BreEStim stimuli will applied for about 20 minutes.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Pain as measured by the visual analog scale (VAS). Scores are recorded from 0 to10. [ Time Frame: Baseline, 5 minutes after intervention ]
    Scores are recorded from 0 to 10 with 0 being "no pain" and 10 being "worst pain."

  2. Change in sensation measured by Electrical sensation detection threshold (EDT) [ Time Frame: Baseline, 5 minutes after intervention ]
    This is self-reported by the subjects as soon as they first sense the electrical current.

  3. Change in pain measured by Electrical pain detection threshold (EPT) [ Time Frame: Baseline, 5 minutes after intervention ]
    This is self-reported by the subjects at the first sensation of pain.

  4. Change in Heart Rate Variability (HRV) measured by electrocardiogram (ECG) [ Time Frame: Baseline, 5 minutes after intervention ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04750538


Contacts
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Contact: Sheng Li, MD, PhD (713) 797-7125 sheng.li@uth.tmc.edu
Contact: Shengai Li, MS 713-797-7561 shengai.li@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center Recruiting
Houston, Texas, United States, 77030
Contact: Shengai Li, MD, PhD    713-500-5874    sheng.li@uth.tmc.edu   
Contact: Shengai Li, MS    (713)797-7561    shengai.li@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institute on Disability, Independent Living, and Rehabilitation Research
Investigators
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Principal Investigator: Sheng Li, MD, PhD The University of Texas Health Science Center, Houston
More Information
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Responsible Party: Sheng Li, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04750538    
Other Study ID Numbers: HSC-MS-20-1032 (Experiment 2)
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Sheng Li, The University of Texas Health Science Center, Houston:
Phantom Limb Pain
BreEStim
Additional relevant MeSH terms:
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Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain