Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
19 participants
INTERVENTIONAL
2018-07-13
2021-09-28
Brief Summary
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Detailed Description
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Unfortunately, data on intraarticular injections is not robust and primarily focused on hip, knee, and disease processes rather than the glenohumeral joint. For example, steroid concentrations have been studied in adhesive capsulitis, where 20 and 40mg of triamcinolone acenotide were used with no statistical significance between the two. When a placebo was added, both doses were better than the placebo, but once again no difference was seen between the two steroid concentrations. Another study, looking at knee osteoarthritis, found that high dose steroids had a larger effect on duration, but other studies have shown no difference in duration between the 40mg and 80mg concentration of triamcinolone acetonide.
Intraarticular injections do have adverse effects. Similar to steroids taken orally or intravenously, intraarticular injections have a similar side effect profile. Fortunately, intraarticular injections are localized, by the nature of the procedure, and the chances of experiencing a significant side effect is rare. The most common side effects are steroid flare, allergic reaction, facial erythema, hypo-pigmentation, fat pad necrosis, cutaneous atrophy, and a transient increase in blood glucose. Some of the rare side effects have been seen in case reports include idiopathic central serous chorioretinopathy, decrease in breast milk production, sepsis, tendon rupture, and cataracts. In addition, the administration of steroid injections are limited to being done every three months due to risk of weakening tendons, and acceleration of cartilage loss.
There is a void of literature for understating the ideal injectable steroid concentrations in glenohumeral osteoarthritis. Because of this, providers who perform intraarticular injections tend to perform them based on prior training experience or anecdotal evidence. We aim to evaluate the ideal steroid concentration that will maximize treatment effect for glenohumeral osteoarthritis, but at the same time minimize side effects, and better train our future providers.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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20 mg Triamcinolone with 3cc of 1% Lidocaine
20mg Triamcinolone with 3cc of 1% Lidocaine
Triamcinolone
Ultrasound guided glenohumeral shoulder joint injection
40 mg Triamcinolone with 3cc of 1% Lidocaine
40mg Triamcinolone with 3cc of 1% Lidocaine
Triamcinolone
Ultrasound guided glenohumeral shoulder joint injection
80 mg Triamcinolone with 3cc of 1% Lidocaine
80mg Triamcinolone with 3cc of 1% Lidocaine
Triamcinolone
Ultrasound guided glenohumeral shoulder joint injection
Interventions
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Triamcinolone
Ultrasound guided glenohumeral shoulder joint injection
Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* Clinical diagnosis established due to symptoms that will include pain attributed to glenohumeral osteoarthritis, pain with range of motion, and/or functional limitations longer than 3 months.
Exclusion Criteria
* Previous diagnosis of inflammatory arthritis, rotator cuff tear, or immunocompromised
* Previous shoulder surgery
* Allergy to steroid or lidocaine
* A Kellgren and Lawrence classification of 1 or less on radiograph
* Non-English Speaking
* Inability to provide informed consent
18 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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Cayce Onks
Assistant Professor of Family and Community Medicine and Orthopedics and Rehabilitation
Principal Investigators
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Cayce Onks, DO
Role: PRINCIPAL_INVESTIGATOR
Penn State Hershey Medical Cen
Locations
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Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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References
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Barbour KE, Helmick CG, Boring M, Brady TJ. Vital Signs: Prevalence of Doctor-Diagnosed Arthritis and Arthritis-Attributable Activity Limitation - United States, 2013-2015. MMWR Morb Mortal Wkly Rep. 2017 Mar 10;66(9):246-253. doi: 10.15585/mmwr.mm6609e1.
McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, Hawker GA, Henrotin Y, Hunter DJ, Kawaguchi H, Kwoh K, Lohmander S, Rannou F, Roos EM, Underwood M. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88. doi: 10.1016/j.joca.2014.01.003. Epub 2014 Jan 24.
Godwin M, Dawes M. Intra-articular steroid injections for painful knees. Systematic review with meta-analysis. Can Fam Physician. 2004 Feb;50:241-8.
Arroll B, Goodyear-Smith F. Corticosteroid injections for osteoarthritis of the knee: meta-analysis. BMJ. 2004 Apr 10;328(7444):869. doi: 10.1136/bmj.38039.573970.7C. Epub 2004 Mar 23.
Gaujoux-Viala C, Dougados M, Gossec L. Efficacy and safety of steroid injections for shoulder and elbow tendonitis: a meta-analysis of randomised controlled trials. Ann Rheum Dis. 2009 Dec;68(12):1843-9. doi: 10.1136/ard.2008.099572. Epub 2008 Dec 3.
Kim YS, Lee HJ, Lee DH, Choi KY. Comparison of high- and low-dose intra-articular triamcinolone acetonide injection for treatment of primary shoulder stiffness: a prospective randomized trial. J Shoulder Elbow Surg. 2017 Feb;26(2):209-215. doi: 10.1016/j.jse.2016.09.034. Epub 2016 Nov 30.
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.
Popma JW, Snel FW, Haagsma CJ, Brummelhuis-Visser P, Oldenhof HG, van der Palen J, van de Laar MA. Comparison of 2 Dosages of Intraarticular Triamcinolone for the Treatment of Knee Arthritis: Results of a 12-week Randomized Controlled Clinical Trial. J Rheumatol. 2015 Oct;42(10):1865-8. doi: 10.3899/jrheum.141630. Epub 2015 Aug 1.
Intra-articular injections for osteoarthritis of the knee. Med Lett Drugs Ther. 2006 Mar 27;48(1231):25-7. No abstract available.
Smuin DM, Seidenberg PH, Sirlin EA, Phillips SF, Silvis ML. Rare Adverse Events Associated with Corticosteroid Injections: A Case Series and Literature Review. Curr Sports Med Rep. 2016 May-Jun;15(3):171-6. doi: 10.1249/JSR.0000000000000259. No abstract available.
McAlindon TE, LaValley MP, Harvey WF, Price LL, Driban JB, Zhang M, Ward RJ. Effect of Intra-articular Triamcinolone vs Saline on Knee Cartilage Volume and Pain in Patients With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA. 2017 May 16;317(19):1967-1975. doi: 10.1001/jama.2017.5283.
Kegel G, Marshall A, Barron OA, Catalano LW, Glickel SZ, Kuhn M. Steroid injections in the upper extremity: experienced clinical opinion versus evidence-based practices. Orthopedics. 2013 Sep;36(9):e1141-8. doi: 10.3928/01477447-20130821-15.
Onks C, Weaver L, Latorre J, Silvis M, Berg A, Phillips S, Loeffert J, French C, Armstrong A. The most effective corticosteroid dose in the treatment of glenohumeral osteoarthritis: Feasibility pilot and protocol for double blinded randomized controlled trial. Osteoarthr Cartil Open. 2024 May 9;6(3):100484. doi: 10.1016/j.ocarto.2024.100484. eCollection 2024 Sep.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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00008490
Identifier Type: -
Identifier Source: org_study_id
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