Assessment of Usability and Satisfaction With a Take-home Device Presenting Sound and Body Stimulation for Back Pain

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

August 11, 2026

Study Completion Date

August 11, 2026

Conditions
Chronic Lower Back Pain
Interventions
DEVICE

TENS device

will be using an FDA- cleared TENS device for electrical stimulation (TENS 7000, Compass Health Brands) in combination with commercially-available headphones for acoustic stimulation (AKG 845 BT).Will be shown how to use the device, trained on the multimodal stimulation procedure, and sent home with the device for 12 weeks.

BEHAVIORAL

Integrative health modalities

will be instructed on the integrative health modalities for this study. They will be given a tablet that includes the videos for the visually guided deep breathing. They will also receive the reflective journal and be set up for health coaching visits. At the end of the 12 weeks, this group of participants will return to the U of M campus and complete an interview about satisfaction and usability of the IH modalities.

Trial Locations (1)

55414

RECRUITING

University of Minnesota, Minneapolis

All Listed Sponsors
lead

University of Minnesota

OTHER