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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the usability, compliance, and satisfaction of a new at-home multi-modal stimulation device designed for people with chronic lower back pain (cLBP). This device combines electrical stimulation, auditory stimulation, and integrative health techniques such as mindfulness breathing, health coaching, and reflective journaling. The study aims to explore these combined approaches since individual treatments like electrical stimulation alone have limited effectiveness in reducing pain symptoms. Participants will be randomly assigned to one of two groups. One group will use an FDA-cleared TENS device combined with headphones for acoustic stimulation at home for 12 weeks. The other group will engage in integrative health modalities including guided deep breathing videos on a tablet, reflective journaling, and health coaching visits. After 12 weeks, participants in the integrative health group will return to the University of Minnesota for an interview about their experience. During the study, researchers will monitor participants' compliance with the device or integrative health practices and measure satisfaction with the device settings and overall design. Outcomes include the compliance rate and satisfaction rate assessed at 12 weeks. Participants must be able to follow study instructions, communicate in English, and commit to the full study duration. The study will exclude individuals with certain medical conditions or who are using conflicting treatments. The study completion date is August 11, 2026.
CONDITIONS
Brief 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 lower back pain lasting more than 3 months
- A score of 4 or higher on the PEG pain scale
- Must be willing to commit to the 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 related to rheumatologic or inflammatory disease
- Back pain caused by trauma, fracture, dislocation, or previous back surgery
- A score of 10 on the PEG pain scale
- Pregnant individuals
- Presence of an electrically implanted device, such as a pacemaker
- Heart disease
- Epilepsy
- Cancer
- Psychiatric conditions including psychosis, suicidal thoughts, or substance abuse disorder
- Hearing loss with a pure tone average over 40 dB at 500, 1000, or 2000 Hz
- Current use of other lower back pain treatments that cannot be kept stable for one month before starting the study regimen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants are trained on using the take-home TENS device with acoustic stimulation or on integrative health modalities including guided deep breathing and health coaching, then use these interventions at home.
Participants use the device or participate in health coaching sessions at home; 1 visit to receive training
Duration - 1 day
Participants complete an interview about their satisfaction and usability of the assigned interventions.
1 visit (in-person) at the end of 12 weeks
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
Research Team
G
Grace Conchas
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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