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:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-24 @ 6:49 PM
NCT ID:
NCT02421757
Eligibility Criteria:
Inclusion Criteria:
1. Adult, age \>18 years of age
2. Prescription pharmacologic treatment is insufficient for treatment of pain
3. Pain duration of ≥ 6 months
4. Pain limits physical activity
5. Pain occurs daily
6. Chronic low back pain, with or without leg pain, associated with MRI or other imaging study consistent with lumbo-sacral spine disease with or without nerve compression
7. Pain intensity ≥ 5 at the time of enrollment a a self-reported pain score of ≥ 4 over the 7 preceding days.
Exclusion Criteria:
1. Life expectancy ≤ 6 months for any reason
2. Oral opiate dosing or type of opioid that has changed in past 12 months
3. Received intraspinal (e.g., epidural, intrathecal) medication in the past 6 months
4. Use of intravenous pain medication in the past 6 months
5. Active use of a transcutaneous electrical nerve stimulator (TENS) \[within 30 days\]
6. History of seizures
7. History of implanted medical device, cardiac pacemaker or implantable cardiac defibrillator, or other implant (Cochlear etc)
8. History of cardiac dysrhythmias
9. Member of vulnerable population
10. Current or potential legal action of disability claim related to back pain
11. Body Mass Index (BMI) \>35
12. Another pain condition that might confound results, including back pain above the waistline
13. Women of child-bearing potential
14. Inability to undergo study assessments or complete questionnaires independently
15. Metal objects in the body (i.e. Aneurysm clip, bullet fragment)
16. Active psychological co-morbidites (i.e. uncontrolled schizophrenia)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02421757
Study Brief:
Protocol Section:
NCT02421757