Epidural Lavage Study for Lumbar Stenosis

NCT03511053 | Completed Results

• 1 other identifier: 17-054
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (3)

• Visual Analogue Scale

  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

  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

  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

Study Arms (1)

All participants

EXPERIMENTAL

Epidural Lavage followed by Lumbar Epidural Steroid Injection

Procedure: Epidural Steroid Injection with Lavage

Interventions

Epidural Steroid Injection with Lavage PROCEDURE

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

All participants

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dallas VA Medical Center: lead
• University of Texas Southwestern Medical Center: collaborator

Study Sites (1)

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Related Publications (15)

• 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.

  PMID: 19468896 BACKGROUND

• 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.

  PMID: 22458343 BACKGROUND

• 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.

  PMID: 18503793 BACKGROUND

• 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.

  PMID: 17632396 BACKGROUND

• 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.

  PMID: 24988555 BACKGROUND

• 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.

  PMID: 26630434 BACKGROUND

• 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.

  PMID: 27548310 BACKGROUND

• 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.

  PMID: 19934811 BACKGROUND

• 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.

  PMID: 21224775 BACKGROUND

• 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.

  PMID: 24239034 BACKGROUND

• 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.

  PMID: 25887469 BACKGROUND

• 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.

  PMID: 22334168 BACKGROUND

• 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.

  PMID: 17974488 BACKGROUND

• 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.

  PMID: 26251843 BACKGROUND

• 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.

  PMID: 31659847 RESULT

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Results Point of Contact

• Title: Dr. Thiru M. Annaswamy, Staff Physician, PM&R Service
• Organization: Dallas VA Medical Center

thiru.annaswamy@va.gov

2148570273

Study Officials

• Thiru M Annaswamy, MD

  Dallas VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PM&R, Principal Investigator, Staff Physician

Model Details: Each participant receives a saline lavage followed by the lumbar epidural steroid injection

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 27, 2018
• Study Start: December 19, 2017
• Primary Completion: July 26, 2018
• Study Completion: July 26, 2018
• Last Updated: May 27, 2021
• Results First Posted: February 8, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)