Epidural Lavage Study for Lumbar Stenosis

May 25, 2021 updated by: Thiru Annaswamy, Dallas VA Medical Center

Using Inflammatory Biomarkers and EMG Results to Predict Epidural Injection Response in Patients Diagnosed With Lumbar Stenosis

The purpose of this research is to find out if there are inflammatory biomarkers (also known as biological markers) in epidural space that can predict response to an epidural steroid injection. This study will also be evaluating whether the results of an EMG study (also known as electromyography) can predict the response to an epidural steroid injection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lumbar spinal stenosis is a common cause of back pain and mobility impairment in older adults. It is often a multi-factorial condition resulting from degenerative changes in the spine, and may result in severe disability, with symptoms of lower back pain and/or pain, numbness and weakness of the lower extremities that are often exacerbated by walking and/or standing. Since lumbar spinal stenosis mostly stems from slowly progressive degenerative changes, symptoms often worsen over time, leading to poor health outcomes and high rates of healthcare utilization.

Epidural steroid injection (ESI) with anti-inflammatory compounds such as glucocorticoids is commonly provided to alleviate pain from neurogenic claudication in spinal stenosis: it is estimated that 25% of ESI's performed in the Medicare population and 74% of ESIs in the Veterans Affairs system are for spinal stenosis. However, one recent, large, multi-center, randomized controlled trial (RCT) demonstrated no significant benefit of epidural corticosteroids in alleviating symptoms of spinal stenosis. In this study, Friedly et al. conducted a double-blind, RCT comparing patient outcomes with epidural injection of glucocorticoid plus anesthetic (lidocaine) vs. anesthetic (lidocaine) only. No significant differences were observed at 6 weeks between the two groups of patients with respect to pain-related functional disability or pain intensity. However, a subset of patients who received glucocorticoids plus lidocaine reported significantly higher treatment satisfaction and higher reductions in depressive symptoms. This suggests that ESIs may be effective for a subset of patients with spinal stenosis.

Another treatment modality for spinal stenosis is decompression surgery, which may be effective for some patients but is associated with higher risk especially in the elderly and patients with multiple medical comorbidities. In Davis et al.'s observational study, in a two-year period with 68 patients, 32% of patients opted for surgery, 44% of patients were satisfied with non-surgical management and were discharged after 2 years, but the remaining 24% with non-surgical management (some of whom chose to decline surgery) did not seem to be satisfied with treatment. This study indicates the potential key role that non-surgical management options such as ESIs may play, in some patients. However, appropriate patient selection using indicators or biomarkers for patients who may most likely benefit from ESIs would be extremely beneficial.

In studying biomarkers that may predict patients' response to ESIs, Scuderi et al. found interferon-gamma (IFG) levels to have high predictive value for patients with lumbar nerve root irritation, while Golish et al. and Smith et al. found fibronectin-aggrecan complex (FAC) levels to have high predictive value for patients with herniated nucleus pulposus (HNP). In addition, many other factors (such as lower age and higher education) have been found to predict better outcome for radiculopathy. In particular, needle electromyography (EMG) has been shown in several studies to be a strong predictor for response to lumbar epidural steroid injection (LESI) and transforaminal epidural steroid injection (TESI) for patients with lumbosacral radiculopathy (LSR). Inspired by these studies, this study aims to explore if certain biomarkers such as IFG & FAC along with EMG findings can help predict which patients with spinal stenosis and neurogenic claudication will optimally benefit from ESIs.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mild-severe lumbar central canal stenosis identified by MRI or CT scan
  • Symptoms:
  • Lower extremety symptoms consistent with neurogenic claudication
  • Pain, weakness and/or numbness triggered by standing or walking, and relieved by sitting
  • Must be able to read English and complete assessment instruments

Exclusion Criteria:

  • Cognitive impairment that renders the patient unable to give informed consent or provide accurate data
  • Clinical co-morbidities that could interfere with the collection of data concerning pain and function
  • Severe vascular, pulmonary, or coronary artery disease that limits ambulation including recent myocardial infarction (within 6 months)
  • Spinal instability requiring surgical fusion
  • Severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis
  • Metastatic cancer
  • Excessive alcohol consumption or evidence of non-prescribed or illegal drug use
  • Pregnancy
  • Concordant pain with internal rotation of the hip (or known hip joint pathology)
  • Active local or systemic infection
  • Abnormal coagulation
  • Allergy to local anesthetic, steroid, or contrast
  • Previous lumbar spine surgery
  • Prisoners
  • Epidural steroid injection within previous 6 months
  • Rheumatological disorders such as rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All participants
Epidural Lavage followed by Lumbar Epidural Steroid Injection
Procedure: Epidural Steroid Injection with Lavage
All participants will receive a saline lavage prior to the epidural steroid injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: Change between baseline, 1 month and 2 months post injection
Number rating of back/leg pain from 0 to 10, 0 being no pain/discomfort, 10 being extreme pain/discomfort
Change between baseline, 1 month and 2 months post injection
Swiss Spinal Stenosis Questionnaire
Time Frame: Change between baseline, 1 month and 2 months post injection
Measures how pain due to spinal stenosis is effected the patient based on quality of life/pain questions and satisfaction questions for months 1 and 2 (no scales are used) SSSQ scores are reported in percentages 0-100%, higher scores indicate worse outcomes.
Change between baseline, 1 month and 2 months post injection
Pain Disability Questionnaire
Time Frame: Change between baseline, 1 month and 2 months post injection
Measures how pain is affecting the patients lifestyle on a scale from 0 to 10 as defined by each question. The questionnaire contains 15 questions that each range on a scale form 0 to 10. The total score of the questionnaire ranges from 0 to 150. Lower values represent a better outcome.
Change between baseline, 1 month and 2 months post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dallas VA Medical Center

Collaborators

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Thiru M Annaswamy, MD, Dallas VA Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2017

Primary Completion (Actual)

July 26, 2018

Study Completion (Actual)

July 26, 2018

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

April 27, 2018

Study Record Updates

Last Update Posted (Actual)

May 27, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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