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

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04751526
• Other study ID #: HSC-MS-20-1032 (Experiment 3)
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Sheng Li, MD, PhD
• Phone: (713) 797-7125
• Email: sheng.li[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 after multiple sessions of treatment.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain Management
• Phantom Limb

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institute on Disability, Independent Living, and Rehabilitation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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."	Baseline, after 10 intervention sessions, about 2 weeks
Primary	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.	Baseline, after 10 intervention sessions, about 2 weeks
Primary	Change in pain measured by Electrical pain detection threshold (EPT)	This is self-reported by the subjects at the first sensation of pain.	Baseline, after 10 intervention sessions, about 2 weeks
Primary	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.	Baseline, after 10 intervention sessions, about 2 weeks