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 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT02148003
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years-old
* Subjects who are able to give informed consent and to understand and comply with study requirements.
* Predominantly axial low back pain ≥ 3 months in duration with no radicular pain below the knee that failed to conservative therapy.
* Subjects who have chronic back pain attributed to lumbar facet joints arthropathy based on clinical evaluation (paraspinal tenderness and/or facet loading test in the absence of signs and symptoms suggestive of focal neurological deficits).
* No history of previous back surgery at the intended treatment levels.
* Adequate response to the diagnostic blocks without the use of steroids at the same levels of the intended block (Defined as ≥ 75% pain relief).
* Patients who will undergo RFA of 3-4 lumbar facet medial branches on one side only.
Exclusion Criteria:
* Subjects who decline to provide written consent or follow-up.
* Subjects who have a history of adverse reactions to local anesthetic.
* Subjects who are pregnant.
* Subjects with bleeding disorders or active anticoagulation that cannot be stopped for few days close to the time of the procedure.
* Subjects who have an active systemic or local infection.
* Presence of radicular pain below the knee.
* Patients who have other specific etiology of low back pain (e.g. significant spinal canal stenosis or grade 2 or 3 spondylolisthesis).
* Secondary gain (i.e., ongoing litigation, worker's compensation or other financial incentives)
* Psychopathology including depression, somatization or poor coping skills
* Physical factors including non-sedentary lifestyle, e.g.; morbid obesity (BMI \> 35kg/m2).
* History of previous RFA at the same level(s) in the previous 12 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02148003
Study Brief:
Protocol Section:
NCT02148003