Device for managing chronic lower back pain at home

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the usability and satisfaction of a take-home device designed to alleviate chronic lower back pain through a combination of electrical and auditory stimulation, along with integrative health techniques such as mindfulness and health coaching. Participants will use the device at home, and the study aims to assess their compliance and overall satisfaction with the treatment. The approach is based on existing knowledge of pain management, integrating multiple modalities to enhance effectiveness. The study targets a diverse population suffering from chronic lower back pain to gather comprehensive feedback on the device's performance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* Must have chronic LBP, which is defined as lower back pain for more than 3 months
* A score of 4 or higher on the PEG
* Must be willing to commit to full duration of the study
* Not currently taking any benzodiazepines or sedative hypnotics

Exclusion Criteria:

* Back Pain associated with:
* Spondylolisthesis or spinal stenosis
* Sciatica or radiculopathy
* Rhematologic or inflammatory disease
* Trauma, fracture, dislocation, or previous back surgery
* A score of 10 on the PEG
* Pregnant
* Have an electrically implanted device, such as a pacemaker.
* Heart Disease
* Epilepsy
* Cancer
* Psychiatric conditions including psychosis, suicidal ideation, or substance abuse disorder
* A pure tone average of more than 40 dB HL at 500 dB, 1000 dB, or 2000 dB HL.
* Individuals currently using other lower back pain treatments during the study in which they are unable to maintain a steady state while participating in our study for one month before beginning the multi-modal regimen.

Where it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Molly Sturges — University of Minnesota
• Study coordinator: Grace Conchas
• Email: buchh123@umn.edu

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.