NCT06619418 Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain
| NCT ID | NCT06619418 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Chronic Lower Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-08-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-07-01 with a primary completion date of 2026-08-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Grace Conchas
✉ buchh123@umn.eduMolly Sturges
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT06619418 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Lower Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06619418 currently recruiting?
Yes, NCT06619418 is actively recruiting participants. Contact the research team at buchh123@umn.edu for enrollment information.
Where is the NCT06619418 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06619418 clinical trial?
NCT06619418 is sponsored by University of Minnesota. The principal investigator is Molly Sturges at University of Minnesota. The trial plans to enroll 20 participants.