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| Name | Class |
|---|---|
| Epimed | INDUSTRY |
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Do cervical epidural steroid injections done by transforaminal catheter targeted approach improve pain and function in patients with cervical radicular pain?
Two distinct techniques used to administer epidural steroids specifically to the nerve root affected in a radicular pain syndrome, which include transforaminal access at the level of pathology and interlaminar interlaminar access at the C7-T1 level with subsequent advancement of an epidural cathether to the level of pathology. Use of an epidural catheter is necessary in order to achieve a targeted injection via an interlaminar approach in order to prevent dural puncture or direct spinal cord trauma. Anatomic studies confirm the distance between the ligamentum flavum and dura is on average, 4 mm at the C7-T1 or C6-C7 levels, but 1mm or smaller at C5-C6 and more rostral levels. Therefore, there is likely greater risk of dural puncture and spinal cord injury when "targeting" steroid delivery using only the interlaminar technique directly at the level where pathology is located (C4-C5, or C5-C6, for example). Thus, the interlaminar placement of a needle rostral to the C6-C7 level has been strongly discouraged.
Both the transforaminal injection approach and the targeted catheter approach demonstrate effectiveness. Studies have demonstrated the effectiveness of transforaminal epidural steroid injection for the treatment of cervical radicular pain. Our own recent work demonstrates the clinical effectiveness of the catheter-based targeted approach. However, these two approaches have never been directly compared. Thus, we aim to compare the differences in pain reduction, medication utilization, functional outcomes, patient satisfaction, and surgical rate reduction between these two approaches to the treatment of cervical radicular pain.
Cervical radicular pain is a common syndrome, often treated with epidural steroid injection (ESI). An approach that targets the therapeutic agent, corticosteroid, at the site of spinal pathology can be performed via a transforaminal approach or via a interlaminar approach at C7-T1 with subsequent epidural catheter advancement to the symptomatic level. There are no universal guidelines that recommend the use of one technique over the other. We will directly compare the clinical effectiveness of these two approaches as measured by pain reduction, medication utilization, functional outcomes, patient satisfaction, and surgical rate reduction. The results of this study will potentially influence clinical practice recommendations regarding the treatment of cervical radicular pain. If one technique proves superior, instating this technique will have implications potentially for reducing opioid use, surgery and other healthcare utilization, and general healthcare cost related to the treatment of cervical radicular pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transforaminal ESI with dexamethasone | Active Comparator | Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate |
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| Transforaminal catheter-targeted ESI with triamcinolone | Active Comparator | Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transforaminal ESI with dexamethasone | Procedure | Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL). |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score | The Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score | 1 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Neck Disability Index-5 | Percentage of patients with >30% improvement in Neck Disability Index-5 score. | 1 month, 3 month, 6 month, and 1 year follow up |
| Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III |
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| Name | Affiliation | Role |
|---|---|---|
| Zachary L McCormick, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Orthopaedic Center | Salt Lake City | Utah | 84108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8186959 | Background | Radhakrishnan K, Litchy WJ, O'Fallon WM, Kurland LT. Epidemiology of cervical radiculopathy. A population-based study from Rochester, Minnesota, 1976 through 1990. Brain. 1994 Apr;117 ( Pt 2):325-35. doi: 10.1093/brain/117.2.325. | |
| 16049211 | Background | Carette S, Fehlings MG. Clinical practice. Cervical radiculopathy. N Engl J Med. 2005 Jul 28;353(4):392-9. doi: 10.1056/NEJMcp043887. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transforaminal ESI With Dexamethasone | Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate Transforaminal ESI with dexamethasone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL). Dexamethasone Sodium Phosphate 10 MG/ML: Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1 Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2017 |
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Prospective, randomized, comparative trial
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Each subject will be randomized into a group assignment in a 1:1 manner, #1 or #2, as outlined in the Methods section
| Transforaminal catheter-targeted ESI with triamcinolone | Procedure | Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL). |
|
| Dexamethasone Sodium Phosphate 10 MG/ML | Drug | Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1 |
|
| Lidocaine | Drug | 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2 |
|
|
| Triamcinolone Acetonide 40mg/mL | Drug | Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2 |
|
|
The Medication Quantification Scale (MQS) is an instrument used for clinical and research applications for quantifying medication regimen use in chronic pain populations. A 6.8 point reduction is considered equivalent to 10 morphine eqivalents.
| 1 month, 3 month, 6 month, and 1 year follow up |
| The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating "Much Improved" and "Very Much Improved") | Patient Global Impression of Change is a scale which measures participant reported satisfaction after an intervention. The outcome was measured as the percent of patients reporting a PGIC score of 6-7 (indicating "much improved" and "very much improved") | 1 month, 3 month, 6 month, and 1 year follow up |
| 10549703 | Background | Heckmann JG, Lang CJ, Zobelein I, Laumer R, Druschky A, Neundorfer B. Herniated cervical intervertebral discs with radiculopathy: an outcome study of conservatively or surgically treated patients. J Spinal Disord. 1999 Oct;12(5):396-401. |
| 23424170 | Background | Johnston MM, Jordan SE, Charles AC. Pain referral patterns of the C1 to C3 nerves: implications for headache disorders. Ann Neurol. 2013 Jul;74(1):145-8. doi: 10.1002/ana.23869. Epub 2013 Jun 17. |
| 21187551 | Background | Mizutamari M, Sei A, Tokiyoshi A, Fujimoto T, Taniwaki T, Togami W, Mizuta H. Corresponding scapular pain with the nerve root involved in cervical radiculopathy. J Orthop Surg (Hong Kong). 2010 Dec;18(3):356-60. doi: 10.1177/230949901001800320. |
| 17664368 | Background | Rhee JM, Yoon T, Riew KD. Cervical radiculopathy. J Am Acad Orthop Surg. 2007 Aug;15(8):486-94. doi: 10.5435/00124635-200708000-00005. |
| 9247921 | Background | Malanga GA. The diagnosis and treatment of cervical radiculopathy. Med Sci Sports Exerc. 1997 Jul;29(7 Suppl):S236-45. doi: 10.1097/00005768-199707001-00006. |
| 1719788 | Background | Renfrew DL, Moore TE, Kathol MH, el-Khoury GY, Lemke JH, Walker CW. Correct placement of epidural steroid injections: fluoroscopic guidance and contrast administration. AJNR Am J Neuroradiol. 1991 Sep-Oct;12(5):1003-7. |
| 4061788 | Background | Mehta M, Salmon N. Extradural block. Confirmation of the injection site by X-ray monitoring. Anaesthesia. 1985 Oct;40(10):1009-12. doi: 10.1111/j.1365-2044.1985.tb10558.x. |
| 11880836 | Background | Stojanovic MP, Vu TN, Caneris O, Slezak J, Cohen SP, Sang CN. The role of fluoroscopy in cervical epidural steroid injections: an analysis of contrast dispersal patterns. Spine (Phila Pa 1976). 2002 Mar 1;27(5):509-14. doi: 10.1097/00007632-200203010-00011. |
| 19807874 | Background | Van Zundert J, Huntoon M, Patijn J, Lataster A, Mekhail N, van Kleef M; Pain Practice. 4. Cervical radicular pain. Pain Pract. 2010 Jan-Feb;10(1):1-17. doi: 10.1111/j.1533-2500.2009.00319.x. Epub 2009 Oct 5. |
| 2167604 | Background | Johansson A, Hao J, Sjolund B. Local corticosteroid application blocks transmission in normal nociceptive C-fibres. Acta Anaesthesiol Scand. 1990 Jul;34(5):335-8. doi: 10.1111/j.1399-6576.1990.tb03097.x. |
| 19165300 | Background | Benyamin RM, Singh V, Parr AT, Conn A, Diwan S, Abdi S. Systematic review of the effectiveness of cervical epidurals in the management of chronic neck pain. Pain Physician. 2009 Jan-Feb;12(1):137-57. |
| 8213020 | Background | Stav A, Ovadia L, Sternberg A, Kaadan M, Weksler N. Cervical epidural steroid injection for cervicobrachialgia. Acta Anaesthesiol Scand. 1993 Aug;37(6):562-6. doi: 10.1111/j.1399-6576.1993.tb03765.x. |
| 7816491 | Background | Castagnera L, Maurette P, Pointillart V, Vital JM, Erny P, Senegas J. Long-term results of cervical epidural steroid injection with and without morphine in chronic cervical radicular pain. Pain. 1994 Aug;58(2):239-243. doi: 10.1016/0304-3959(94)90204-6. |
| 8875719 | Background | Saal JS, Saal JA, Yurth EF. Nonoperative management of herniated cervical intervertebral disc with radiculopathy. Spine (Phila Pa 1976). 1996 Aug 15;21(16):1877-83. doi: 10.1097/00007632-199608150-00008. |
| 11097449 | Background | Riew KD, Yin Y, Gilula L, Bridwell KH, Lenke LG, Lauryssen C, Goette K. The effect of nerve-root injections on the need for operative treatment of lumbar radicular pain. A prospective, randomized, controlled, double-blind study. J Bone Joint Surg Am. 2000 Nov;82(11):1589-93. doi: 10.2106/00004623-200011000-00012. |
| 15069129 | Background | Buttermann GR. Treatment of lumbar disc herniation: epidural steroid injection compared with discectomy. A prospective, randomized study. J Bone Joint Surg Am. 2004 Apr;86(4):670-9. |
| 16055268 | Background | Huntoon MA. Anatomy of the cervical intervertebral foramina: vulnerable arteries and ischemic neurologic injuries after transforaminal epidural injections. Pain. 2005 Sep;117(1-2):104-11. doi: 10.1016/j.pain.2005.05.030. |
| 17762818 | Background | Abbasi A, Malhotra G, Malanga G, Elovic EP, Kahn S. Complications of interlaminar cervical epidural steroid injections: a review of the literature. Spine (Phila Pa 1976). 2007 Sep 1;32(19):2144-51. doi: 10.1097/BRS.0b013e318145a360. |
| 25668411 | Background | Rathmell JP, Benzon HT, Dreyfuss P, Huntoon M, Wallace M, Baker R, Riew KD, Rosenquist RW, Aprill C, Rost NS, Buvanendran A, Kreiner DS, Bogduk N, Fourney DR, Fraifeld E, Horn S, Stone J, Vorenkamp K, Lawler G, Summers J, Kloth D, O'Brien D Jr, Tutton S. Safeguards to prevent neurologic complications after epidural steroid injections: consensus opinions from a multidisciplinary working group and national organizations. Anesthesiology. 2015 May;122(5):974-84. doi: 10.1097/ALN.0000000000000614. |
| 27922950 | Background | McCormick ZL, Nelson A, Bhave M, Zhukalin M, Kendall M, McCarthy RJ, Khan D, Nagpal G, Walega DR. A Prospective Randomized Comparative Trial of Targeted Steroid Injection Via Epidural Catheter Versus Standard C7-T1 Interlaminar Approach for the Treatment of Unilateral Cervical Radicular Pain. Reg Anesth Pain Med. 2017 Jan-Feb;42(1):82-89. doi: 10.1097/AAP.0000000000000521. |
| 17456677 | Background | Ackerman WE 3rd, Ahmad M. The efficacy of lumbar epidural steroid injections in patients with lumbar disc herniations. Anesth Analg. 2007 May;104(5):1217-22, tables of contents. doi: 10.1213/01.ane.0000260307.16555.7f. |
| 22086091 | Background | Gharibo CG, Varlotta GP, Rhame EE, Liu EC, Bendo JA, Perloff MD. Interlaminar versus transforaminal epidural steroids for the treatment of subacute lumbar radicular pain: a randomized, blinded, prospective outcome study. Pain Physician. 2011 Nov-Dec;14(6):499-511. |
| 17066121 | Background | Schaufele MK, Hatch L, Jones W. Interlaminar versus transforaminal epidural injections for the treatment of symptomatic lumbar intervertebral disc herniations. Pain Physician. 2006 Oct;9(4):361-6. |
| 25212440 | Background | Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Focus article: report of the NIH Task Force on Research Standards for Chronic Low Back Pain. Eur Spine J. 2014 Oct;23(10):2028-45. doi: 10.1007/s00586-014-3540-3. |
| 19836888 | Background | Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, Rauschkolb C, Sampaio C. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009 Dec;146(3):238-244. doi: 10.1016/j.pain.2009.08.019. |
| 18402665 | Background | Kovacs FM, Abraira V, Royuela A, Corcoll J, Alegre L, Tomas M, Mir MA, Cano A, Muriel A, Zamora J, Del Real MT, Gestoso M, Mufraggi N; Spanish Back Pain Research Network. Minimum detectable and minimal clinically important changes for pain in patients with nonspecific neck pain. BMC Musculoskelet Disord. 2008 Apr 10;9:43. doi: 10.1186/1471-2474-9-43. |
| 18211588 | Background | Gallizzi M, Gagnon C, Harden RN, Stanos S, Khan A. Medication Quantification Scale Version III: internal validation of detriment weights using a chronic pain population. Pain Pract. 2008 Jan-Feb;8(1):1-4. doi: 10.1111/j.1533-2500.2007.00163.x. |
| FG001 | Transforaminal Catheter-targeted ESI With Triamcinolone | Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide Transforaminal catheter-targeted ESI with triamcinolone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL). Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2 Triamcinolone Acetonide 40mg/mL: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Transforaminal ESI With Dexamethasone | Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate Transforaminal ESI with dexamethasone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL). Dexamethasone Sodium Phosphate 10 MG/ML: Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1 Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2 |
| BG001 | Interlaminar Catheter-targeted ESI With Triamcinolone | Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide Transforaminal catheter-targeted ESI with triamcinolone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL). Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2 Triamcinolone Acetonide 40mg/mL: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score | The Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score | >50% Pain Reduction scored with 95% Confidence Interval. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month follow up |
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| Secondary | Neck Disability Index-5 | Percentage of patients with >30% improvement in Neck Disability Index-5 score. | Analysis was done for different timelines of one month, three months, six months, and one year. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month, 3 month, 6 month, and 1 year follow up |
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| Secondary | Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III | The Medication Quantification Scale (MQS) is an instrument used for clinical and research applications for quantifying medication regimen use in chronic pain populations. A 6.8 point reduction is considered equivalent to 10 morphine eqivalents. | Analysis was done for different timelines of one month, three months, six months, and one year. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month, 3 month, 6 month, and 1 year follow up |
| ||||||||||||||||||||||||||||||
| Secondary | The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating "Much Improved" and "Very Much Improved") | Patient Global Impression of Change is a scale which measures participant reported satisfaction after an intervention. The outcome was measured as the percent of patients reporting a PGIC score of 6-7 (indicating "much improved" and "very much improved") | Analysis was done for different timelines of one month, three months, six months, and one year. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month, 3 month, 6 month, and 1 year follow up |
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1 year
The definition does not differ from that outlined from clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transforaminal ESI With Dexamethasone | Group 1: Transforaminal cervical ESI with dexamethasone sodium phosphate Transforaminal ESI with dexamethasone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL). Dexamethasone Sodium Phosphate 10 MG/ML: Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1 Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2 | 0 | 60 | 0 | 60 | 0 | 60 |
| EG001 | Interlaminar Catheter-targeted ESI With Triamcinolone | Group 2: Catheter-targeted cervical ESI with triamcinolone acetonide Transforaminal catheter-targeted ESI with triamcinolone: Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL). Lidocaine: 1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2 Triamcinolone Acetonide 40mg/mL: Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2 | 0 | 57 | 0 | 57 | 0 | 57 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zachary McCormick | University of Utah, Department of Physical Medicine and Rehabilitation | 801-587-5432 | PMR.Research@hsc.utah.edu |
| Aug 19, 2020 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D014221 | Triamcinolone |
| C004180 | dexamethasone 21-phosphate |
| D008012 | Lidocaine |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Between 18 and 65 years |
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| >=65 years |
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