Osteoarthritis Shoulder Injection Study

• Sponsor: Milton S. Hershey Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03586687
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Arms: 3
• Actual Duration (Months): 38.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Glenohumeral Osteoarthritis	Drug: Triamcinolone	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Outcomes Following Randomization of Steroid Concentration in Patients With Glenohumeral Osteoarthritis
• Actual Study Start Date: Jul 13, 2018
• Actual Primary Completion Date: Sep 28, 2021
• Actual Study Completion Date: Sep 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 20 mg Triamcinolone with 3cc of 1% Lidocaine 20mg Triamcinolone with 3cc of 1% Lidocaine	Drug: Triamcinolone; Ultrasound guided glenohumeral shoulder joint injection
Active Comparator: 40 mg Triamcinolone with 3cc of 1% Lidocaine 40mg Triamcinolone with 3cc of 1% Lidocaine	Drug: Triamcinolone; Ultrasound guided glenohumeral shoulder joint injection
Active Comparator: 80 mg Triamcinolone with 3cc of 1% Lidocaine 80mg Triamcinolone with 3cc of 1% Lidocaine	Drug: Triamcinolone; Ultrasound guided glenohumeral shoulder joint injection

Outcome Measures

Primary Outcome Measures

1. Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. [baseline, 2, 4, and 6 months. Baseline SPADI score was collected prior to injection.]

   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

2. Assess Reactions to the Steroid [baseline, 2, 4, and 6 months. Baseline data was collected at 2wks post injection phone call.]

   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.

Secondary Outcome Measures

1. Rate of Shoulder Arthroplasty Following Injection [12 months]

   Shoulder arthroplasty is defined as total shoulder replacement

2. Change in Overall SPADI Scores for Those Receiving Shoulder Arthroplasty at 1 Year [12 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

• Milton S. Hershey Medical Center

Investigators

• Principal Investigator: Cayce Onks, DO, Penn State Hershey Medical Cen

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 2, 2021

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• Intra-articular injections for osteoarthritis of the knee. Med Lett Drugs Ther. 2006 Mar 27;48(1231):25-7.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Cayce Onks, Assistant Professor of Family and Community Medicine and Orthopedics and Rehabilitation, Milton S. Hershey Medical Center
• ClinicalTrials.gov Identifier: NCT03586687
• Other Study ID Numbers: 00008490
• First Posted: Jul 13, 2018
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Cayce Onks, Assistant Professor of Family and Community Medicine and Orthopedics and Rehabilitation, Milton S. Hershey Medical Center: Ultrasound guided injection
• Additional relevant MeSH terms: Osteoarthritis; Triamcinolone

Study Results

Participant Flow

Arm/Group Title	20 mg Triamcinolone With 3cc of 1% Lidocaine	40 mg Triamcinolone With 3cc of 1% Lidocaine	80 mg Triamcinolone With 3cc of 1% Lidocaine
Arm/Group Description	20mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	40mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	80mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection
Period Title: Overall Study
STARTED	6	9	4
COMPLETED	6	9	4
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	20 mg	40 mg	80 mg	Total
Arm/Group Description	20mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	40mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	80mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	Total of all reporting groups
Overall Participants	6	9	4	19
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.67 (12.26)	69.33 (6.93)	64.50 (12.29)	66.53 (9.79)
Sex: Female, Male (Count of Participants)
Female	2 33.3%	4 44.4%	3 75%	9 47.4%
Male	4 66.7%	5 55.6%	1 25%	10 52.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months.
Description	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
Time Frame	baseline, 2, 4, and 6 months. Baseline SPADI score was collected prior to injection.

Outcome Measure Data

Analysis Population Description

Difference in subjects analyzed for all arms was due to the need of subsequent treatment

Arm/Group Title	20 mg Triamcinolone With 3cc of 1% Lidocaine	40 mg Triamcinolone With 3cc of 1% Lidocaine	80 mg Triamcinolone With 3cc of 1% Lidocaine
Arm/Group Description	20mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	40mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	80mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection
Measure Participants	6	9	4
Baseline SPADI Score	58.17 (17.88)	60.67 (17.91)	44.50 (18.34)
2 month SPADI Score	30.60 (22.60)	48.67 (22.01)	22.25 (19.97)
4 month SPADI Score	44.80 (30.11)	51.12 (27.53)	35.67 (34.43)
6 month SPADI Score	44.60 (25.60)	57.71 (18.62)	26.00 (7.07)

2. Primary Outcome

Title	Assess Reactions to the Steroid
Description	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.
Time Frame	baseline, 2, 4, and 6 months. Baseline data was collected at 2wks post injection phone call.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	20 mg Triamcinolone With 3cc of 1% Lidocaine	40 mg Triamcinolone With 3cc of 1% Lidocaine	80 mg Triamcinolone With 3cc of 1% Lidocaine
Arm/Group Description	20mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	40mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	80mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection
Measure Participants	6	9	4
Baseline	1	2	0
2 month follow up	0	0	0
4 month follow up	0	0	0
6 month follow up	0	0	0

3. Secondary Outcome

Title	Rate of Shoulder Arthroplasty Following Injection
Description	Shoulder arthroplasty is defined as total shoulder replacement
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	20 mg Triamcinolone With 3cc of 1% Lidocaine	40 mg Triamcinolone With 3cc of 1% Lidocaine	80 mg Triamcinolone With 3cc of 1% Lidocaine
Arm/Group Description	20mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	40mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	80mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection
Measure Participants	6	9	4
Count of Participants [Participants]	3 50%	1 11.1%	1 25%

4. Secondary Outcome

Title	Change in Overall SPADI Scores for Those Receiving Shoulder Arthroplasty at 1 Year
Description	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
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Subjects who underwent shoulder arthroplasty by/at 12 months

Arm/Group Title	20 mg Triamcinolone With 3cc of 1% Lidocaine	40 mg Triamcinolone With 3cc of 1% Lidocaine	80 mg Triamcinolone With 3cc of 1% Lidocaine
Arm/Group Description	20mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	40mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection	80mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection
Measure Participants	1	1	1
Mean (Standard Deviation) [score on a scale]	2 (NA)	12 (NA)	4 (NA)

Adverse Events

Time Frame	Adverse events were collected for 6 months
Arm/Group Title	20 mg		40 mg		80 mg
Arm/Group Description	20mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection		40mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection		80mg Triamcinolone with 3cc of 1% Lidocaine Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection
All Cause Mortality
	20 mg		40 mg		80 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/9 (0%)		0/4 (0%)
Serious Adverse Events
	20 mg		40 mg		80 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/9 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	20 mg		40 mg		80 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/6 (16.7%)		2/9 (22.2%)		0/4 (0%)
General disorders
Steroid flare	0/6 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0
Facial flushing	1/6 (16.7%)	1	0/9 (0%)	0	0/4 (0%)	0
Nervous system disorders
Headaches	0/6 (0%)	0	1/9 (11.1%)	1	0/4 (0%)	0

Limitations/Caveats

Target enrollment was not reached due to the COVID pandemic. The secondary outcome measure involving SPADI at 12 months were not collected due to COVID pandemic.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.