Actively Recruiting
Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain
Led by University of Minnesota · Updated on 2025-08-13
20
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pain symptoms can have a variety of ways to be treated, from medications to physical therapy, with several options being available to patients. However, no one treatment may work for all people who experience pain, especially cLBP. The purpose of this study is to measure the compliance, usability, and satisfaction of an at-home, multi-modal stimulation device in a diverse population of people with chronic lower back pain (cLBP). The multi-modal device will include a combination of electrical stimulation, auditory stimulation, and integrative-health techniques, including mindfulness breathing, health coaching, and reflective journaling. The multi-modal device creation is based on prior knowledge in lower back pain treatment, which includes electrical stimulation of the back (Transcutaneous Electrical Nerve Stimulator or TENS) and integrative health modalities. In isolation, these treatments are only somewhat effective in reducing symptoms. This pilot study will involve participants who experience cLBP as we investigate a novel at-home, multi-modal device design. The main objective of the pilot usability study is to examine compliance to the intended use of the multi-modal device and approach, as well as protocol feasibility, and satisfaction with the settings and design.
CONDITIONS
Official Title
Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years of age or older
- Must be within commuting distance to the University of Minnesota
- Able to provide consent and follow study instructions
- Must be able to understand English
- Must have chronic LBP, which is defined as lower back pain for more than 3 months
- A score of 4 or higher on the PEG
- Must be willing to commit to full duration of the study
- Not currently taking any benzodiazepines or sedative hypnotics
You will not qualify if you...
- Back pain associated with spondylolisthesis or spinal stenosis
- Back pain associated with sciatica or radiculopathy
- Back pain associated with rheumatologic or inflammatory disease
- Back pain associated with trauma, fracture, dislocation, or previous back surgery
- A score of 10 on the PEG
- Pregnant
- Have an electrically implanted device, such as a pacemaker
- Heart disease
- Epilepsy
- Cancer
- Psychiatric conditions including psychosis, suicidal ideation, or substance abuse disorder
- A pure tone average of more than 40 dB HL at 500 dB, 1000 dB, or 2000 dB HL
- Currently using other lower back pain treatments without a steady state for one month before starting the study regimen
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
Research Team
G
Grace Conchas
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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