Clinical trial

Defining the Threshold Response of Lumbar Selective Nerve Root Block in Predicting Good Outcome Following Lumbar Foraminotomy

Name

18-718

Description

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.

Trial arms

Trial start

2018-08-23

Estimated PCD

2020-11-05

Trial end

2020-12-15

Status

Terminated

Phase

Early phase I

Treatment

Selective Nerve Root Block

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.

Arms:

Selective Nerve Root Block

Size

Primary endpoint

Visual Analog Scale (VAS) Leg Pain Score

12-months

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Subjects will be enrolled into a single treatment participant pool.', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}

Updated at

2023-07-21

1 organization

1 product

3 indications

Organization

The Cleveland Clinic

Product

Selective Nerve Root Block

Indication

Back Pain

Indication

Lumbar Radiculopathy

Indication

Degenerative lumbar spinal stenosis