Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619418
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None