NCT04751526

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pain Management

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-02
• Primary completion: 2024-02-22
• Completion: 2024-02-22
• First posted: 2021-02-12
• Last updated: 2025-03-20
• Results posted: 2025-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study