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 range18 Years – 80 Years

SexALL

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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

What they're measuring

Visual Analog Scale (VAS) Leg Pain Score

Timeframe: 12-months

Trial details

NCT IDNCT03801356

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-05

Results submitted2023-02-08