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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT01104051
Eligibility Criteria:
Inclusion Criteria:
* 1\. 18 years old, or older 2. Unilateral or Bilateral LBP or Buttocks Pain for greater than six months with a 3 day average VAS greater or equal to 4 on a 1-10 scale 3. Tenderness over the SI joint 4. 75% or greater relief of pain (with return to baseline) during the local anesthetic phase of two separate, one fluoroscopically guided intra-articular SI joint injection and one lateral branch block (see Appendix A) 5. Stable medications for pain for the last seven days 6. Have used at least 3 alternative treatments for pain without success (se 7. BMI less than 35.0
Exclusion Criteria:
1. Focal Neurologic Signs
2. Any component of pain related to Lumbar Z-joints at L4-5 and/or L5-S1 as determined by one set of medial branch blocks
3. Previous radiofrequency procedure within the last 6 months
4. Moderate or greater spinal stenosis
5. Greater than Grade 2 listhesis
6. Foraminal Stenosis; marked to severe
7. Previous Lumbar Spine Surgery
8. Unstable Medical or Psychological Conditions as determined by the investigator
9. Concomitant cervical or thoracic pain greater than 2/10 on VAS
10. Workers compensation, disability or litigation
11. Pregnancy, breast feeding or planning on becoming pregnant during the trial
12. Subject unwillingness to complete study related activities
13. Current Smoker; unless quit greater than 6 months -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01104051
Study Brief:
Protocol Section:
NCT01104051