Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumb… (NCT03801356) | Clinical Trial Compass
TerminatedPhase 4
Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
Stopped: The study was terminated early due to a number of concurrent issues: low enrollment, limited data and COVID-19.
United States11 participantsStarted 2018-08-23
Plain-language summary
SNRB, as measured by the change in pain and objective functional ability, can solicit crucial information regarding a patient's clinical picture and can predict a patient's outcome post-surgery. By using the walk test as an objective functional assessment, the aim is to better standardize the threshold for a positive response to SNRB.
In summary, SNRB, despite utilized frequently in the diagnostic work-up with patients with lumbar radiculopathy, vary widely in their sensitivity and specificity. The reasons, as outlined above, are multifactorial. The proposed study aims to minimize the known limitations of these injections and prospectively define their positive and negative predictive value in a homogenous group of patients undergoing surgery for lumbar foraminal stenosis and radiculopathy. The design will define a threshold of response utilizing both subjective and objective measures and more accurately predict excellent results following surgery.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ages 18-80
* Diagnosis of unilateral lower extremity radiculopathy due to degenerative foraminal stenosis
* Patients scheduled for an associated lumbar foraminotomy procedure
* Diagnosis of radiculopathy with imaging and/or clinical history or physical exam that does not demonstrate a clear neurogenic source of their pain
* Subjects must be available for the entire study duration (12 months)
Exclusion Criteria:
* Patients will be excluded if there is a clear correlation between imaging and radiculopathy
* Radiculopathy associated with trauma, tumor or infection. Non-radicular lower extremity pain will also be excluded
* Patients who cannot tolerate the SNRB without IV sedation
* Surgery requiring multi-level decompression and/or fusion
* Surgical indication for malignancy, injection or acute or emergency trauma
* History of major surgery within 3 months prior to enrollment
* Pregnant females
* Presence of severe acute, chronic medical or psychiatric condition
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.