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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 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.

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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.

Conditions Studied

Interventions

  • DEVICE TENS device
  • BEHAVIORAL Integrative health modalities

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2024-07-01
Est. Completion 2026-08-11
Phase NA

Sponsor

University of Minnesota

966 total trials

What the Registry Record Tells You About NCT06619418

The ClinicalTrials.gov registry entry for NCT06619418 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 153-participant average among 5 other Chronic Lower Back Pain trials with a reported enrollment target (87% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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