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NCT06619418 · ClinicalTrials.gov registry record · NA
Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain
A NA study of Chronic Lower Back Pain, sponsored by University of Minnesota.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06619418: Recruiting NA study of Chronic Lower Back Pain, sponsored by University of Minnesota.
NCT06619418 is a NA study of Chronic Lower Back Pain that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 20 participants, below the 153-participant average among 5 other Chronic Lower Back Pain trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06619418, a NA study of Chronic Lower Back Pain, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Measure compliance in terms of time using the integrative health devices and the multi-modal stimulation device over a period of 12 weeks to determine the effect on participant compliance by adding electrical stimulation to the device.
Conditions Studied
Interventions
- DEVICE TENS device
- BEHAVIORAL Integrative health modalities
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-07-01 |
| Est. Completion | 2026-08-11 |
| Phase | NA |
What NCT06619418 shows while recruiting
NCT06619418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 153-participant average among 5 other Chronic Lower Back Pain trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Chronic Lower Back Pain appearing as the primary indexed condition, and to 2 interventions - of which TENS device is the first listed.
NCT06619418 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06619418 about?
NCT06619418 is a clinical study titled "Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain". 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, a...
What is the current status of trial NCT06619418?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-07-01. Estimated completion is 2026-08-11.
What conditions does trial NCT06619418 study?
This clinical trial studies the following conditions: Chronic Lower Back Pain.
What interventions are being tested in trial NCT06619418?
The interventions under investigation include: TENS device (DEVICE), Integrative health modalities (BEHAVIORAL).
Who is sponsoring clinical trial NCT06619418?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06619418 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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