Device for managing chronic lower back pain at home
Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain
This study is testing a new take-home device that uses electrical and sound therapy, along with mindfulness and coaching, to see if it helps people with chronic lower back pain feel better and be satisfied with their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06619418 on ClinicalTrials.gov |
What this trial studies
This study evaluates the usability and satisfaction of a take-home device designed to alleviate chronic lower back pain through a combination of electrical and auditory stimulation, along with integrative health techniques such as mindfulness and health coaching. Participants will use the device at home, and the study aims to assess their compliance and overall satisfaction with the treatment. The approach is based on existing knowledge of pain management, integrating multiple modalities to enhance effectiveness. The study targets a diverse population suffering from chronic lower back pain to gather comprehensive feedback on the device's performance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic lower back pain lasting more than three months who can commute to the University of Minnesota.
Not a fit: Patients with specific back conditions, such as spondylolisthesis or spinal stenosis, or those with certain medical histories like heart disease or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide an effective at-home solution for managing chronic lower back pain, improving patients' quality of life.
How similar studies have performed: While the integration of multiple modalities for pain management is a growing area of interest, this specific approach using a take-home device is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Molly Sturges — University of Minnesota
- Study coordinator: Grace Conchas
- Email: buchh123@umn.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.