Status:
TERMINATED
Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Lumbar Spine Research Society
Conditions:
Back Pain
Radiculopathy Lumbar
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 us...
Detailed Description
The proposed study will identify the threshold response level that quantifies the predictive value of diagnostic SNRBs in patients who present with lumbar foraminal stenosis and radiculopathy. Specifi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03801356
Start Date
August 23 2018
End Date
December 15 2020
Last Update
July 21 2023
Active Locations (1)
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1
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195