Clinical trial NCT03801356: Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
Official title: Defining the Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Back Pain
Radiculopathy Lumbar
Degenerative Lumbar Spinal Stenosis
Keywords: back pain
lumbar spine pain
nerve root block
foraminotomy
radiculopathy
lumbar
foraminal stenosis
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Lumbar Spine Research Society
First posted: 2019-01-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will be enrolled into a single treatment participant pool.
Primary purpose: DIAGNOSTIC

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 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.

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. Specifically, the proposed study will address the question of whether there is a degree or length of response to SNRB, which predicts an excellent surgical outcome. The hypothesis is that diagnostic SNRBs, when performed correctly, are useful in localizing the level of involvement in LSS and improve the accuracy and efficacy of surgical intervention. Use of diagnostic SNRBs will thus be used to clarify the clinical picture, giving the surgeon the information to make the right decision to operate or not, and, in the case of operation, predicting the optimal level(s) for surgical intervention. In addition, the investigators plan to identify and fully characterize a standard threshold level and time of nerve block response that will optimize the accuracy, specificity, and sensitivity of SNRB in predicting surgical outcomes.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale (VAS) Leg Pain Score
timeFrame: 12-months
Secondary outcomes:
measure: Oswestry Disability Index Questionnaire (ODI)
timeFrame: 12-Months
measure: EQ-5D Questionnaire
timeFrame: 12-Months
measure: Pain Disability Questionnaire (PDQ)
timeFrame: 12-months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Michael Steinmetz, MD
role: PRINCIPAL_INVESTIGATOR
References: