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

Purpose

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

  • Pain Management

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

The University of Texas Health Science Center
Houston, Texas 77030
Contact:
Shengai Li, MD, PhD
713-797-7125
sheng.li@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Sheng Li, MD, PhD
(713) 797-7125
sheng.li@uth.tmc.edu