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 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT04693650
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 20
2. Subject has been diagnosed with chronic, intractable pain of the trunk and/or limb(s) and is refractory to conservative therapy for a minimum of six months prior to the screening/baseline visit.
3. Subject has an average pain score of back or leg ≥ 5 or maximum pain score of back or leg ≥ 7 on the Visual Analogue Scale (VAS).
4. Subject is willing and able to comply with the procedure and requirements of this trial.
5. The subject is able to understand and provide informed consent, and has signed their written informed consent in accordance with IRB requirements.
Exclusion Criteria:
1. Subject has the following conditions by investigator's discretion at screening visit or during the last 3 months:
1. has the mental or psychological condition that affects pain perception or
2. has difficulty performing objective pain assessment or lack of suitability for participation in the study.
2. Subject has exhibited unstable pain condition within the past 28 days as interviewed by Investigator.
3. Subject has a currently diagnosed coagulation disorder, bleeding diathesis, progressive peripheral vascular disease with PLT \< 100,000/μl or INR \> 1.4 at screening visit.
4. Subject has unstable pain medication(s) for at least 28 days at investigator's discretion.
5. Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (MRIs) or diathermy.
6. Subject has a current diagnosis of cancer with active symptoms.
7. Subject has a known terminal illness with life expectancy less than one year.
8. Subject has a systematic or local infection, which may increase study risk.
9. Subject currently has an indwelling device that may pose an increased risk of infection.
10. Subject is pregnant or breast feeding.
11. Subject has a medical history of drug or alcohol addiction within the past 2 years.
12. Subject has participation in any investigational study in the last 30 days or current enrollment in any trial.
13. Subject is currently involved in an injury claim law suit or medically related litigation, including workers compensation.
14. Subject is a prisoner.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT04693650
Study Brief:
Protocol Section:
NCT04693650