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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT02707094
Eligibility Criteria:
Inclusion Criteria:
* active duty Service Members (SMs) between the ages of 18 and 62, inclusive
* history of chronic LBP (i.e. intermittent or continuous LBP symptoms present for 3 months or greater prior to entry into the study
* participants must be using narcotic and/or non-narcotic oral analgesic medications to treat their chronic LBP symptoms on a weekly basis
* must be able to speak and read English and understand the study procedures
Exclusion Criteria:
* pacemaker or implanted electronic device
* history of stroke, blood clots, or cardiac arrhythmias
* pregnancy
* no self-reported history of prescription medication abuse or sole-provider contract for prescribed narcotic medications
* open wound over site of chronic pain;
* history of spinal surgery
* participation in a clinical trial for an investigational drug/ treatment within last 30 days
* undergone treatment with TENS, biofeedback, or acupuncture within last 30 days
* prior treatment with the Biomodulator
* LBP "red flags": fever, trauma, progressive motor or sensory deficit, saddle anesthesia
* participation in the study would delay the medical board (MEB) processing of the service member off of active duty status or would delay a return to duty status to their home unit
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
62 Years
Study:
NCT02707094
Study Brief:
Protocol Section:
NCT02707094