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

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 after multiple sessions of treatment.

Condition

  • Pain Management

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
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 240, then EStim 240 		BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.
  • Device: BreEStim 240
    240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
  • Device: EStim 240
    240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
Experimental
EStim 240, then BreEstim 240 		EStim is transcutaneous electrical nerve stimulation.
  • Device: BreEStim 240
    240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
  • Device: EStim 240
    240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.

More Details

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

Study Contact

Detailed Description

Subjects will receive 10-session BreEStim and 10-session EStim treatment in a random order. The interval between BreEStim and EStim is at least 2 weeks. The following assessment will be made before and after 1. Visual analogue scale (VAS). 2. Quantitative sensory testing (QST). It includes non-invasive assessment of tactile sensation threshold (TST), electrical sensation threshold (EST), electrical pain threshold (EPT), and thermal thresholds. 3. Hear rate variability (HRV). It consists of 5-minute electrocardiogram (ECG) recording before and after a treatment session.