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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT07178951
Eligibility Criteria:
Inclusion Criteria:
1. Moderate to severe, predominantly medial chronic knee pain
2. Age adult \>18 years old
3. WOMAC Score of 30 or higher
4. NRS\>6 with ambulation
5. Radiological confirmation of knee osteoarthritis (Kellgren-Lawrence Scale: 2-4)
6. Participants in whom the measured skin to bone depth is 2-6 cm using imaging ultrasound and ultrasound gel pad in the upper medial and lower medial joint capsule targets.
Exclusion Criteria:
1. Individuals meeting any of the following criteria are not eligible for participation in this study:
2. Individuals after any surgery associated with altered integrity of bone structure
3. Individuals with severe pain in the second knee
4. Individuals unable to understand and complete the research questionnaires in the official language
5. Individuals presenting with any severe medical condition preventing the participant from safely and effectively being treated in the study or reporting study outcomes, per PI decision
6. Individuals with extensive scarring of the skin and tissue overlying the treatment area
7. Individuals enrolled in or planned to be enrolled in another clinical trial during the duration of this research project
8. Individuals with active inflammatory (e.g., rheumatoid) arthritis
9. Individuals with concomitant mental health disorders, excluding compensated mood disorders
10. Individuals with altered perception and processing of pain: Average NRS \> 9, PCS\>30, SSS-8 \> 11, CSI\>40 \[46\], \[47\], \[48\]
11. Individuals with a first-degree family member already enrolled in this study
12. Individuals who are scheduled for any interventional/surgical procedure within 3 months from the screening date, excluding trivial surgeries (e.g., cataract, skin tumors)
13. Inability to attend follow-up visits and physiotherapy due to travel distance or other restrictions
14. Symptomatic multifocal nociplastic chronic pain (e.g., fibromyalgia, generalized osteoarthritis) or any other chronic pain condition that could influence symptoms.
15. Participants who have undergone radiofrequency ablation of the genicular nerves in the planned treatment limb within the preceding 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07178951
Study Brief:
Protocol Section:
NCT07178951