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.
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
Spondylolisthesis or spinal stenosis
Sciatica or radiculopathy
Rhematologic or inflammatory disease
Trauma, fracture, dislocation, or previous back surgery
Parallel
TENS device
Devicewill 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.
Integrative health modalities
Behavioralwill 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.
compliance rate
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.
satisfaction rate
relating to usability of an at-home multi-modal stimulation approach and device and integrative health practices..
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