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 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT01995461
Eligibility Criteria:
Inclusion Criteria:
* Symptoms of back/buttock/leg pain (NOT radicular pain) in a neurogenic claudicatory fashion, relieved by stooping or sitting down, for at least 3 months with no or poor response to conservative treatment (analgesics, NSAIDs, or physical therapy)
* Patients with bilateral buttock and/or bilateral lower extremity pain in a neurogenic fashion with or without lower back pain
* Radiologic documentation of degree of degenerative lumbar spinal stenosis (DLSS)
* MRI/CT showing at least moderate central canal spinal stenosis (neuro-radiologist definition) with symptoms correlating with stenosis (symptoms of back/buttock/leg pain without unilateral radicular pain in a neurogenic claudicatory fashion, relieved by stooping or sitting down)
* Patients choosing to receive BTESI as their next treatment option, following discussions with their spine doctor
* Patients who can give informed consent, could tolerate the procedure, and who are able to understand and answer the forms and questionnaires properly.
Exclusion Criteria:
* Radiologic spinal stenosis without symptoms of spinal stenosis
* Symptoms of neurogenic claudication without at least moderate degree of radiologic spinal stenosis
* Patients with specific lumbo-sacral radicular symptoms or radiculopathy (radicular pain secondary to a single nerve root compression/inflammation; usually follows a specific dermatome in lower extremities; unilateral radiculopathy either from disc herniation or lateral recess stenosis)
* Patients with vascular claudication (pain in the legs secondary to arterial insufficiency)
* Previous lumbo-sacral surgery
* Any condition that does not allow the patient to stand and/or walk for any length of time (e.g., COPD, severe lung disease, etc.)
* Patients with symptomatic hip joint pathology concurrent with spinal stenosis
* A coexisting musculoskeletal condition that would negate functional improvement from the injection (e.g., severe Parkinson disease, hemiparesis, etc.)
* Malignancy or infection to the spine
* Another pain generating condition that would mask the improvement provided by the injection
* Patients who had lumbar epidural steroid injections within the past six months
* Significant psychologic diagnosis and/or dementia
* Patients receiving workman's compensation benefit
* Patients unable to give consent on their own, or who are not able to understand and answer the forms and questionnaires, or their answers will not be reliable.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
90 Years
Study:
NCT01995461
Study Brief:
Protocol Section:
NCT01995461