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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-02

Study Completion Date

2024-02-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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BreEStim 240, then EStim 240

BreEStim is voluntary breathing controlled transcutaneous electrical nerve stimulation.

Group Type EXPERIMENTAL

BreEStim 240

Intervention Type DEVICE

240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.

EStim 240

Intervention Type DEVICE

240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.

EStim 240, then BreEstim 240

EStim is transcutaneous electrical nerve stimulation.

Group Type EXPERIMENTAL

BreEStim 240

Intervention Type DEVICE

240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.

EStim 240

Intervention Type DEVICE

240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.

Interventions

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BreEStim 240

240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.

Intervention Type DEVICE

EStim 240

240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No