Lumbar Spinal Stenosis Clinical Trial
Official title:
Using Inflammatory Biomarkers and EMG Results to Predict Epidural Injection Response in Patients Diagnosed With Lumbar Stenosis
NCT number | NCT03511053 |
Other study ID # | 17-054 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 19, 2017 |
Est. completion date | July 26, 2018 |
Verified date | May 2021 |
Source | Dallas VA Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | July 26, 2018 |
Est. primary completion date | July 26, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Dallas VA Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Dallas VA Medical Center | University of Texas Southwestern Medical Center |
United States,
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. — View Citation
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. — View Citation
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. Epub 2007 Nov 5. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum in: N Engl J Med. 2014 Jul 24;371(4):390. — View Citation
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. — View Citation
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. — View Citation
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;16:17. doi: 10.1186/s12891-015-0474-9. — View Citation
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. — View Citation
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). pii: e140. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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