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 @ 2:00 PM
Ignite Modification Date:
2025-12-24 @ 2:00 PM
NCT ID:
NCT05396495
Eligibility Criteria:
Inclusion Criteria:
1. Adult male and females, legally able and willing to participate in the study and come for follow-up visits
2. Able and willing to fill the research questionnaires and to communicate with investigator and research team
3. Patient with bilateral or unilateral sacroiliac joint pain of \> 6 months duration
4. Patients presenting with a) a positive (\>70% pain relief) to a previous nerve ablation procedure of the sacroiliac joint and / or b) with a positive (\>70% pain relief) to a previous nerve block procedure of the sacroiliac joint within the last six months)
5. Average pain score of 4 or higher in the last month, (on 0-10 scale).
Exclusion Criteria:
1. Pregnant or breastfeeding patient
2. Patients younger than 18 or older than 80 years
3. Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
4. Patients with history of lumbar and / or sacral spine surgery
5. Patients with the presence of metal hardware at the lumbosacral spine
6. Patients with history of pelvic pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event (per the discretion of the study PI)
7. Patients unable to understand and complete the research questionnaires in Hebrew.
8. Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.
9. Patient with extensive scarring in the skin and tissue overlying the treatment area.
10. Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05396495
Study Brief:
Protocol Section:
NCT05396495