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:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT03614793
Eligibility Criteria:
Inclusion Criteria:
* Adult patients aged \> 21 capable of understanding and providing consent in English and capable of complying with the outcome instruments used.
* Axial (non-radicular) back pain for at least 3 months (ie Chronic Low Back Pain), with pain lasting at least half of the days within those 3 months, that did not respond to conventional treatment such as physical therapy, oral analgesic agents, and non-invasive adjunctive treatments. The pain can be unilateral or bilateral. The pain can also include referred lower limb pain.
* 7-day worst numeric pain rating score (NPRS) for back pain of 5/10 or greater at baseline evaluation.
* Positive responses to dual comparative diagnostic MBN blocks using 0.5mL of 0.5% bupivacaine and 4% lidocaine, on respective encounters on separate days, at each of the appropriate MBNs. The blocks are administered in a double-blind fashion so that neither the subject nor the independent assessor is aware of the local anesthetic used.
Exclusion Criteria:
* Focal neurologic signs or symptoms.
* Radiologic evidence of a symptomatic herniated disc or nerve root impingement related to spinal stenosis.
* Active systemic or local infections at the site of proposed needle and electrode placement.
* Coagulopathy or other bleeding disorder.
* Receipt of remuneration for their pain treatment (e.g. disability, worker's compensation, auto injury in litigation or pending litigation).
* History of any lumbar or lower thoracic fusion surgery or placement of other hardware.
* \> Grade 2 Spondylolisthesis at an affected or adjacent level.
* Cobb angle \>10 degrees.
* Sagittal vertical axis angle \>5 degrees
* BMI \>40.
* Incarceration.
* Cognitive deficit affecting ability to complete the assessment instruments.
* Inability to read English and complete the assessment instruments.
* Allergy to local anesthetics.
* Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
* Prior lumbar MBN radiofrequency neurotomy.
* Addictive behavior, severe clinical depression, anxiety, or any mental health condition with psychotic features.
* Possible pregnancy or other reason that precludes the use of fluoroscopy.
* Daily chronic opiate use of \>50 morphine equivalents.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03614793
Study Brief:
Protocol Section:
NCT03614793