Epidural Lavage Study for Lumbar Stenosis

NCT ID: NCT03511053

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-19
• Study Completion Date: 2018-07-26

Brief Summary

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.

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.

Conditions

Lumbar Spinal Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All participants

Epidural Lavage followed by Lumbar Epidural Steroid Injection

Group Type: EXPERIMENTAL

Epidural Steroid Injection with Lavage

Intervention Type: PROCEDURE

All participants will receive a saline lavage prior to the epidural steroid injection.

Interventions

Epidural Steroid Injection with Lavage

All participants will receive a saline lavage prior to the epidural steroid injection.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: collaborator

Dallas VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Thiru Annaswamy

Professor, PM&R, Principal Investigator, Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thiru M Annaswamy, MD

Role: PRINCIPAL_INVESTIGATOR

Dallas VA Medical Center

Locations

Dallas VA Medical Center

Dallas, Texas, United States

Countries

United States

References

Harrast MA. Epidural steroid injections for lumbar spinal stenosis. Curr Rev Musculoskelet Med. 2008 Mar;1(1):32-8. doi: 10.1007/s12178-007-9003-2.

Reference Type: BACKGROUND

PMID: 19468896 (View on PubMed)

Friedly JL, Bresnahan BW, Comstock B, Turner JA, Deyo RA, Sullivan SD, Heagerty P, Bauer Z, Nedeljkovic SS, Avins AL, Nerenz D, Jarvik JG. Study protocol- Lumbar Epidural steroid injections for Spinal Stenosis (LESS): a double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults. BMC Musculoskelet Disord. 2012 Mar 29;13:48. doi: 10.1186/1471-2474-13-48.

Reference Type: BACKGROUND

PMID: 22458343 (View on PubMed)

Friedly J, Nishio I, Bishop MJ, Maynard C. The relationship between repeated epidural steroid injections and subsequent opioid use and lumbar surgery. Arch Phys Med Rehabil. 2008 Jun;89(6):1011-5. doi: 10.1016/j.apmr.2007.10.037.

Reference Type: BACKGROUND

PMID: 18503793 (View on PubMed)

Friedly J, Chan L, Deyo R. Increases in lumbosacral injections in the Medicare population: 1994 to 2001. Spine (Phila Pa 1976). 2007 Jul 15;32(16):1754-60. doi: 10.1097/BRS.0b013e3180b9f96e.

Reference Type: BACKGROUND

PMID: 17632396 (View on PubMed)

Friedly JL, Comstock BA, Turner JA, Heagerty PJ, Deyo RA, Sullivan SD, Bauer Z, Bresnahan BW, Avins AL, Nedeljkovic SS, Nerenz DR, Standaert C, Kessler L, Akuthota V, Annaswamy T, Chen A, Diehn F, Firtch W, Gerges FJ, Gilligan C, Goldberg H, Kennedy DJ, Mandel S, Tyburski M, Sanders W, Sibell D, Smuck M, Wasan A, Won L, Jarvik JG. A randomized trial of epidural glucocorticoid injections for spinal stenosis. N Engl J Med. 2014 Jul 3;371(1):11-21. doi: 10.1056/NEJMoa1313265.

Reference Type: BACKGROUND

PMID: 24988555 (View on PubMed)

Suri P, Pashova H, Heagerty PJ, Jarvik JG, Turner JA, Bauer Z, Annaswamy TM, Nedeljkovic SS, Wasan AD, Friedly JL. Authors' Reply to Manchikanti. Spine (Phila Pa 1976). 2016 Feb;41(3):E183-4. doi: 10.1097/BRS.0000000000001142. No abstract available.

Reference Type: BACKGROUND

PMID: 26630434 (View on PubMed)

Davis N, Hourigan P, Clarke A. Transforaminal epidural steroid injection in lumbar spinal stenosis: an observational study with two-year follow-up. Br J Neurosurg. 2017 Apr;31(2):205-208. doi: 10.1080/02688697.2016.1206188. Epub 2016 Aug 22.

Reference Type: BACKGROUND

PMID: 27548310 (View on PubMed)

Scuderi GJ, Cuellar JM, Cuellar VG, Yeomans DC, Carragee EJ, Angst MS. Epidural interferon gamma-immunoreactivity: a biomarker for lumbar nerve root irritation. Spine (Phila Pa 1976). 2009 Oct 1;34(21):2311-7. doi: 10.1097/BRS.0b013e3181af06b6.

Reference Type: BACKGROUND

PMID: 19934811 (View on PubMed)

Golish SR, Hanna LS, Bowser RP, Montesano PX, Carragee EJ, Scuderi GJ. Outcome of lumbar epidural steroid injection is predicted by assay of a complex of fibronectin and aggrecan from epidural lavage. Spine (Phila Pa 1976). 2011 Aug 15;36(18):1464-9. doi: 10.1097/BRS.0b013e3181f40e88.

Reference Type: BACKGROUND

PMID: 21224775 (View on PubMed)

Smith MW, Ith A, Carragee EJ, Cheng I, Alamin TF, Golish SR, Mitsunaga K, Scuderi GJ, Smuck M. Does the presence of the fibronectin-aggrecan complex predict outcomes from lumbar discectomy for disc herniation? Spine J. 2019 Feb;19(2):e28-e33. doi: 10.1016/j.spinee.2013.06.064. Epub 2013 Nov 13.

Reference Type: BACKGROUND

PMID: 24239034 (View on PubMed)

Iversen T, Solberg TK, Wilsgaard T, Waterloo K, Brox JI, Ingebrigtsen T. Outcome prediction in chronic unilateral lumbar radiculopathy: prospective cohort study. BMC Musculoskelet Disord. 2015 Feb 7;16(1):17. doi: 10.1186/s12891-015-0474-9.

Reference Type: BACKGROUND

PMID: 25887469 (View on PubMed)

Annaswamy TM, Bierner SM, Chouteau W, Elliott AC. Needle electromyography predicts outcome after lumbar epidural steroid injection. Muscle Nerve. 2012 Mar;45(3):346-55. doi: 10.1002/mus.22320.

Reference Type: BACKGROUND

PMID: 22334168 (View on PubMed)

Fish DE, Shirazi EP, Pham Q. The use of electromyography to predict functional outcome following transforaminal epidural spinal injections for lumbar radiculopathy. J Pain. 2008 Jan;9(1):64-70. doi: 10.1016/j.jpain.2007.08.011. Epub 2007 Nov 5.

Reference Type: BACKGROUND

PMID: 17974488 (View on PubMed)

McCormick Z, Cushman D, Caldwell M, Marshall B, Ghannad L, Eng C, Patel J, Makovitch S, Chu SK, Babu AN, Walega DR, Marciniak C, Press J, Kennedy DJ, Plastaras C. Does Electrodiagnostic Confirmation of Radiculopathy Predict Pain Reduction after Transforaminal Epidural Steroid Injection? A Multicenter Study. J Nat Sci. 2015 Aug;1(8):e140.

Reference Type: BACKGROUND

PMID: 26251843 (View on PubMed)

Lin CK, Borresen A, Kroll M, Annaswamy TM. Predicting Response to Epidural Steroid Injections for Lumbar Spinal Stenosis with Biomarkers and Electromyography. PM R. 2020 Jul;12(7):663-670. doi: 10.1002/pmrj.12272. Epub 2019 Dec 28.

Reference Type: RESULT

PMID: 31659847 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

17-054

Identifier Type: -

Identifier Source: org_study_id