drugset / Trial / NCT04278833
Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions
RandomizedParallel-groupSingle-blindTreatment
Summary
This aims of this study are: 1. To determine if particulate or non-particulate corticosteroid injections are more effective at treating pain from musculoskeletal pathologies of the hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa at 2 weeks, 3 months, or 6 months. 2. To determine if there is a significantly different side effect profile between particulate and non-particulate corticosteroids when used for hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa injections.
Timeline
- Start
- 2020-09-01
- Primary completion
- 2021-05-28
- Completion
- 2021-05-28
Publications
- Background Buchbinder R, Green S, Forbes A, Hall S, Lawler G. Arthrographic joint distension with saline and steroid improves function and reduces pain in patients with painful stiff shoulder: results of a randomised, double blind, placebo controlled trial. Ann Rheum Dis. 2004 Mar;63(3):302-9. doi: 10.1136/ard.2002.004655.
- Background Daniels EW, Cole D, Jacobs B, Phillips SF. Existing Evidence on Ultrasound-Guided Injections in Sports Medicine. Orthop J Sports Med. 2018 Feb 22;6(2):2325967118756576. doi: 10.1177/2325967118756576. eCollection 2018 Feb.
- Background Dawley JD, Moeller-Bertram T, Wallace MS, Patel PM. Intra-arterial injection in the rat brain: evaluation of steroids used for transforaminal epidurals. Spine (Phila Pa 1976). 2009 Jul 15;34(16):1638-43. doi: 10.1097/BRS.0b013e3181ac0018.
- Background Denis I, Claveau G, Filiatrault M, Fugere F, Fortin L. Randomized Double-Blind Controlled Trial Comparing the Effectiveness of Lumbar Transforaminal Epidural Injections of Particulate and Nonparticulate Corticosteroids for Lumbosacral Radicular Pain. Pain Med. 2015 Sep;16(9):1697-708. doi: 10.1111/pme.12846. Epub 2015 Jun 22.
- Background Derby R, Lee SH, Date ES, Lee JH, Lee CH. Size and aggregation of corticosteroids used for epidural injections. Pain Med. 2008 Mar;9(2):227-34. doi: 10.1111/j.1526-4637.2007.00341.x.
- Background Dreyfuss P, Baker R, Bogduk N. Comparative effectiveness of cervical transforaminal injections with particulate and nonparticulate corticosteroid preparations for cervical radicular pain. Pain Med. 2006 May-Jun;7(3):237-42. doi: 10.1111/j.1526-4637.2006.00162.x.
- Background Hajialilo M, Ghorbanihaghjo A, Valaee L, Kolahi S, Rashtchizadeh N, Amirkhiz MB, Malekmahdavi I, Khabbazi A. A double-blind randomized comparative study of triamcinolone hexacetonide and dexamethasone intra-articular injection for the treatment of knee joint arthritis in rheumatoid arthritis. Clin Rheumatol. 2016 Dec;35(12):2887-2891. doi: 10.1007/s10067-016-3397-4. Epub 2016 Aug 29.
- Background Hong JY, Yoon SH, Moon DJ, Kwack KS, Joen B, Lee HY. Comparison of high- and low-dose corticosteroid in subacromial injection for periarticular shoulder disorder: a randomized, triple-blind, placebo-controlled trial. Arch Phys Med Rehabil. 2011 Dec;92(12):1951-60. doi: 10.1016/j.apmr.2011.06.033. Epub 2011 Oct 25.
- Background Kennedy DJ, Plastaras C, Casey E, Visco CJ, Rittenberg JD, Conrad B, Sigler J, Dreyfuss P. Comparative effectiveness of lumbar transforaminal epidural steroid injections with particulate versus nonparticulate corticosteroids for lumbar radicular pain due to intervertebral disc herniation: a prospective, randomized, double-blind trial. Pain Med. 2014 Apr;15(4):548-55. doi: 10.1111/pme.12325. Epub 2014 Jan 2.
- Background Laemmel E, Segal N, Mirshahi M, Azzazene D, Le Marchand S, Wybier M, Vicaut E, Laredo JD. Deleterious Effects of Intra-arterial Administration of Particulate Steroids on Microvascular Perfusion in a Mouse Model. Radiology. 2016 Jun;279(3):731-40. doi: 10.1148/radiol.2015142746. Epub 2016 Jan 13.
- Background Lambert RG, Hutchings EJ, Grace MG, Jhangri GS, Conner-Spady B, Maksymowych WP. Steroid injection for osteoarthritis of the hip: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2007 Jul;56(7):2278-87. doi: 10.1002/art.22739.
- Background Lee HJ, Lim KB, Kim DY, Lee KT. Randomized controlled trial for efficacy of intra-articular injection for adhesive capsulitis: ultrasonography-guided versus blind technique. Arch Phys Med Rehabil. 2009 Dec;90(12):1997-2002. doi: 10.1016/j.apmr.2009.07.025.
- Background Mehta P, Syrop I, Singh JR, Kirschner J. Systematic Review of the Efficacy of Particulate Versus Nonparticulate Corticosteroids in Epidural Injections. PM R. 2017 May;9(5):502-512. doi: 10.1016/j.pmrj.2016.11.008. Epub 2016 Nov 30.
- Background Okubadejo GO, Talcott MR, Schmidt RE, Sharma A, Patel AA, Mackey RB, Guarino AH, Moran CJ, Riew KD. Perils of intravascular methylprednisolone injection into the vertebral artery. An animal study. J Bone Joint Surg Am. 2008 Sep;90(9):1932-8. doi: 10.2106/JBJS.G.01182.
- Background Ring D, Lozano-Calderon S, Shin R, Bastian P, Mudgal C, Jupiter J. A prospective randomized controlled trial of injection of dexamethasone versus triamcinolone for idiopathic trigger finger. J Hand Surg Am. 2008 Apr;33(4):516-22; discussion 523-4. doi: 10.1016/j.jhsa.2008.01.001.
- Background Roh YH, Yi SR, Noh JH, Lee SY, Oh JH, Gong HS, Baek GH. Intra-articular corticosteroid injection in diabetic patients with adhesive capsulitis: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2012 Oct;20(10):1947-52. doi: 10.1007/s00167-011-1776-6. Epub 2011 Nov 24.
- Background Yoon SH, Lee HY, Lee HJ, Kwack KS. Optimal dose of intra-articular corticosteroids for adhesive capsulitis: a randomized, triple-blind, placebo-controlled trial. Am J Sports Med. 2013 May;41(5):1133-9. doi: 10.1177/0363546513480475. Epub 2013 Mar 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Betamethasone | Other / unclassified | 3 mg | Other |
| Subject | Betamethasone | Other / unclassified | 9 mg | Other |
| Subject | Dexamethasone | Small molecule | 4 mg | Other |
| Subject | Dexamethasone | Small molecule | 10 mg | Other |
| Subject | Triamcinolone | Other / unclassified | 10 mg | Other |
| Subject | Triamcinolone | Other / unclassified | 80 mg | Other |