Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
| Status: | Recruiting |
|---|---|
| Conditions: | Back Pain, Neurology, Orthopedic |
| Therapuetic Areas: | Musculoskeletal, Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/6/2019 |
| Start Date: | August 23, 2018 |
| End Date: | August 23, 2019 |
| Contact: | Tracy M Barbour |
| Email: | barbout@ccf.org |
| Phone: | 216-445-1741 |
Defining the Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy
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.
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.
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.
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.
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
We found this trial at
1
site
Cleveland, Ohio 44195
Principal Investigator: Michael Steinmetz, MD
Phone: 216-445-1741
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