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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota

About this trial

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

Qualifiers

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

Disqualifiers

Spondylolisthesis or spinal stenosis

Sciatica or radiculopathy

Rhematologic or inflammatory disease

Trauma, fracture, dislocation, or previous back surgery

Trial design

Treatments tested in this trial

  • TENS device
  • Integrative health modalities

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators