Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT06619418
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06619418
Study Brief:
Protocol Section:
NCT06619418