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 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT03957395
Eligibility Criteria:
Inclusion Criteria:
1. FBSS, CRPS patients with neuropathic and mixed pain in low-back and/or legs refractory to conservative therapy
2. Chronic pain as a result of FBSS that exists for at least 6 months
3. ≥ 18 years of age
4. Written consent of the patient to participate in study procedures.
Exclusion Criteria:
1. Active malignancy
2. Addiction to any of the following: drugs, alcohol and/or medication
3. Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
4. Local infection or other skin disorder at site of surgical incision
5. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03957395
Study Brief:
Protocol Section:
NCT03957395