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

NCT03801356 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 18-718
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain; Radiculopathy Lumbar; Degenerative Lumbar Spinal Stenosis

Keywords

back pain; lumbar spine pain; nerve root block; foraminotomy; radiculopathy; lumbar; foraminal stenosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Oswestry Disability Index Questionnaire (ODI)

  12-Months

• EQ-5D Questionnaire

  12-Months

• Pain Disability Questionnaire (PDQ)

  12-months

Study Arms (1)

Selective Nerve Root Block

OTHER

Patient will receive a Selective Nerve Root Block injection at the target level prior to surgical intervention.

Drug: Selective Nerve Root Block

Interventions

Selective Nerve Root Block DRUG

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.

Selective Nerve Root Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Lumbar Spine Research Society: collaborator

Study Sites (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Back Pain; Low Back Pain; Radiculopathy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Michael Steinmetz
• Organization: Cleveland Clinic

STEINMM@ccf.org

216-445-5754

Study Officials

• Michael Steinmetz, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Subjects will be enrolled into a single treatment participant pool.

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: August 23, 2018
• Primary Completion: November 5, 2020
• Study Completion: December 15, 2020
• Last Updated: July 21, 2023
• Results First Posted: July 21, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)