Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain
- NCT ID
- NCT06619418
- Registry status
- Recruiting
- Study type
- Not specified in the registry data
- Phase
- Not applicable
- Sponsor
- University of Minnesota
Overview
ClinicalTrials.gov lists this study as Recruiting.
Enrollment: 20 participants (Estimated).
What is being studied
No interventions are listed in the registry data.
Who may be eligible
- Ages
- Not specified in the registry data
- Sex
- Not specified in the registry data
- Healthy volunteers accepted
- No
ClinicalTrials.gov lists the following eligibility criteria.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Back Pain associated with:
* Spondylolisthesis or spinal stenosis
* Sciatica or radiculopathy
* Rhematologic or inflammatory disease
* 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.
* Individuals currently using other lower back pain treatments during the study in which they are unable to maintain a steady state while participating in our study for one month before beginning the multi-modal regimen.
Study locations
1 study location is listed.
Site recruitment status is not specified in the registry data for these locations.
Countries: United States
- Minnesota, United States: 1
Sample of listed locations
- University of Minnesota — Minneapolis, Minnesota, 55414, United States — Site recruitment status not specified in the registry data
Study details
- Start date
- November 18, 2024
- Primary completion date
- August 11, 2027
- First posted
- October 1, 2024
Source and update information
- Source
- ClinicalTrials.gov
- NCT ID
- NCT06619418
- Registry last updated
- August 20, 2026
- QualifiedStudies registry data refreshed
- September 21, 2026
View NCT06619418 on ClinicalTrials.gov
Trial information can change. Confirm current study details with the study team or the registry.
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