Osteoarthritis Shoulder Injection Study

Glenohumeral Osteoarthritis Clinical Trial

Official title:

Clinical Outcomes Following Randomization of Steroid Concentration in Patients With Glenohumeral Osteoarthritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03586687
• Other study ID #: 00008490
• Status: Terminated
• Phase: Phase 4
• Start date: July 13, 2018
• Est. completion date: September 28, 2021

Study information

• Verified date: February 2022
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Osteoarthritis (OA) affects 54.4 million US adults and 23.7 million (43.5%) have arthritis-attributable activity limitation. As the condition progresses, pain and functional disability increase. Patients usually begin treatment with conservative measures including physical therapy and administration of nonsteroidal anti-inflammatory drugs before obtaining a corticosteroid injection. Corticosteroid injections have a patient-specific duration that often provide relief for a month before the effects begin to taper with most individuals returning to baseline by 2-3 months post injection. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Glenohumeral Osteoarthritis
• Osteoarthritis

Intervention

Drug:
• Triamcinolone
Ultrasound guided glenohumeral shoulder joint injection

Locations

Country	Name	City	State
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (12)

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

Outcome

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