NCT03801356|TerminatedPhase 4ResultsFDA Drug
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The study was terminated early due to a number of concurrent issues: low enrollment, limited data and COVID-19.
Defining the Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
Sponsor study identifier
interventional
11
1 country
1
Study Start
August 23, 2018
Actual (reported)Primary Completion
November 5, 2020
Actual (reported)Study Completion
December 15, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 15, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 23, 2018
Actual (reported)January 9, 2019
Actual (reported)January 11, 2019
Actual (reported)November 5, 2020
Actual (reported)December 15, 2020
Actual (reported)July 21, 2023
Actual (reported)Visual Analog Scale (VAS) Leg Pain Score
Aim: 0-2 point improvement The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (0) and 'pain as bad as it could be' (10). The patient is asked to mark their pain level on the line between the two endpoints. The distance and change between '0' and the mark then defines the subject's pain. This will be measured at each subject visit.
12-months
Oswestry Disability Index Questionnaire (ODI)
12-Months
EQ-5D Questionnaire
12-Months
Patient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention.
Prior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195, United States
The study was terminated early due to a number of concurrent issues. We found it difficult to enroll patients. Many of the patients were from out of region and/or had presented with a concurrent spinal injection. A new study injection could not be ordered due to the aforementioned issues. We attempted to mitigate, but it proved to be difficult.
Michael Steinmetz, MD
The Cleveland Clinic
11 participants (actual enrollment reported by the registry).
First Submitted
January 9, 2019
First Posted
January 11, 2019
Study Start
August 23, 2018
Actual (reported)Comparison of Intraspinal Nerve Root Stimulation With Dorsal Column Stimulation
Pain Disability Questionnaire (PDQ)
12-months
Contact the study team to confirm eligibility.
Primary Completion
November 5, 2020
Actual (reported)Study Completion
December 15, 2020
Actual (reported)Last Updated
July 21, 2023
Results First Posted
July 21, 2023
Record last verified: 2023-06
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Source: ClinicalTrials.gov.
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