Glenohumeral Osteoarthritis Clinical Trial
Official title:
Clinical Outcomes Following Randomization of Steroid Concentration in Patients With Glenohumeral Osteoarthritis
Verified date | February 2022 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine the most effective intraarticular steroid dose for the treatment of glenohumeral osteoarthritis. The investigators aim to randomize patients into low, medium, and high dose groups of injectable corticosteroids as these doses are typically used in the standard of care for our patients. To date there has been no study to evaluate which dose is most efficient with the fewest side effects for glenohumeral osteoarthritis. The investigators objective will be to provide ultrasound guided intraarticular glenohumeral injections of these randomized concentrations and to evaluate pain and function before and following injection with the Shoulder Pain and Disability Index (SPADI). The investigators hypothesize that the low dose steroid will provide equivalent improvement of the pain and function to the medium and high doses, while minimizing side effects.
Status | Terminated |
Enrollment | 19 |
Est. completion date | September 28, 2021 |
Est. primary completion date | September 28, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - An X-ray within a year with Radiographic evidence of OA - 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 guided steroid injection of the glenohumeral joint within 3 months - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Milton S. Hershey Medical Center | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center |
United States,
Arroll B, Goodyear-Smith F. Corticosteroid injections for osteoarthritis of the knee: meta-analysis. BMJ. 2004 Apr 10;328(7444):869. Epub 2004 Mar 23. — View Citation
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. — View Citation
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. Review. — View Citation
Godwin M, Dawes M. Intra-articular steroid injections for painful knees. Systematic review with meta-analysis. Can Fam Physician. 2004 Feb;50:241-8. Review. Erratum in: Can Fam Physician. 2009 Jun;55(6):590. — View Citation
Intra-articular injections for osteoarthritis of the knee. Med Lett Drugs Ther. 2006 Mar 27;48(1231):25-7. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. | The Shoulder Pain and Disability Index (SPADI) measures current shoulder pain and disability using a 13 item assessment. Scores range from 0-100 with higher scores indicating greater impairment or disability | baseline, 2, 4, and 6 months. Baseline SPADI score was collected prior to injection. | |
Primary | Assess Reactions to the Steroid | Adverse events will only include those that are determined to be related to steroid Adverse Reactions to the Steroid are reported as combined for all the participants and not at the per-participant level. | baseline, 2, 4, and 6 months. Baseline data was collected at 2wks post injection phone call. | |
Secondary | Rate of Shoulder Arthroplasty Following Injection | Shoulder arthroplasty is defined as total shoulder replacement | 12 months | |
Secondary | Change in Overall SPADI Scores for Those Receiving Shoulder Arthroplasty at 1 Year | The Shoulder Pain and Disability Index (SPADI) measures current shoulder pain and disability using a 13 item assessment. Scores range from 0-100 with higher scores indicating greater impairment or disability | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01726972 -
A Retrospective Review of FloSeal Use in Total Shoulder Arthroplasty
|
||
Completed |
NCT06043544 -
Hymovis® Intra-articular Injections vs Corticosteroids Intra-articular Injections in Patients Affected by Glenohumeral Osteoarthritis:
|
Phase 4 | |
Recruiting |
NCT05847062 -
Clinical Trial to Analyze Lateralized Models and Medializations of Inverted Arthroplasty.
|
N/A | |
Recruiting |
NCT04105478 -
Comparison of Stemless and Stemmed Shoulder Arthroplasty for Osteoarthritis
|
N/A | |
Recruiting |
NCT03866330 -
Wharton's Jelly-derived Mesenchymal Stem Cells in Osteoarthritis
|
Phase 1/Phase 2 | |
Recruiting |
NCT04845074 -
Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis
|
N/A | |
Completed |
NCT03379545 -
3D MR Versus 3D CT for Glenohumeral Arthritis
|
N/A | |
Recruiting |
NCT06269705 -
ZILRETTA in Subjects With Glenohumeral Osteoarthritis
|
Phase 3 | |
Active, not recruiting |
NCT06171542 -
Efficacy of a Single Image Guided Injection of CTM for Glenohumeral Arthritis
|
Phase 1 | |
Completed |
NCT00436969 -
ORTHOVISC Shoulder Osteoarthritis Study
|
Phase 3 | |
Recruiting |
NCT03869229 -
Adipose-derived Mesenchymal Stem Cells in Osteoarthritis
|
Phase 1/Phase 2 | |
Completed |
NCT00500630 -
Objective Evaluation of Shoulder Pathology and Surgery
|
N/A |