NCT03586687

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

July 13, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2021

Completed
5 months until next milestone

Results Posted

Study results publicly available

March 2, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

3.2 years

First QC Date

June 21, 2018

Results QC Date

November 30, 2021

Last Update Submit

February 8, 2022

Conditions

Glenohumeral Osteoarthritis

Keywords

Ultrasound guided injection

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (2)

  • Rate of Shoulder Arthroplasty Following Injection

    12 months

  • Change in Overall SPADI Scores for Those Receiving Shoulder Arthroplasty at 1 Year

    12 months

Study Arms (3)

20 mg Triamcinolone with 3cc of 1% Lidocaine

ACTIVE COMPARATOR

20mg Triamcinolone with 3cc of 1% Lidocaine

Drug: Triamcinolone

40 mg Triamcinolone with 3cc of 1% Lidocaine

ACTIVE COMPARATOR

40mg Triamcinolone with 3cc of 1% Lidocaine

Drug: Triamcinolone

80 mg Triamcinolone with 3cc of 1% Lidocaine

ACTIVE COMPARATOR

80mg Triamcinolone with 3cc of 1% Lidocaine

Drug: Triamcinolone

Interventions

TriamcinoloneDRUG

Ultrasound guided glenohumeral shoulder joint injection

20 mg Triamcinolone with 3cc of 1% Lidocaine40 mg Triamcinolone with 3cc of 1% Lidocaine80 mg Triamcinolone with 3cc of 1% Lidocaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An X-ray within a year with Radiographic evidence of OA
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (13)

  • 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.

    PMID: 28278145BACKGROUND

  • 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.

    PMID: 24462672BACKGROUND

  • Godwin M, Dawes M. Intra-articular steroid injections for painful knees. Systematic review with meta-analysis. Can Fam Physician. 2004 Feb;50:241-8.

    PMID: 15000335BACKGROUND

  • 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.

    PMID: 15039276BACKGROUND

  • 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.

    PMID: 19054817BACKGROUND

  • 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.

    PMID: 27914846BACKGROUND

  • 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.

    PMID: 23507791BACKGROUND

  • 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.

    PMID: 26233499BACKGROUND

  • Intra-articular injections for osteoarthritis of the knee. Med Lett Drugs Ther. 2006 Mar 27;48(1231):25-7. No abstract available.

    PMID: 16554699BACKGROUND

  • 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.

    PMID: 27172081BACKGROUND

  • 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.

    PMID: 28510679BACKGROUND

  • 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.

    PMID: 24025004BACKGROUND

  • 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.

    PMID: 38800822DERIVED

MeSH Terms

Interventions

Triamcinolone

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Limitations and 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.

Results Point of Contact

Title
Cayce Onks, DO
Organization
Penn State Hershey Medical Center
conks@pennstatehealth.psu.edu
7175317127

Study Officials

  • Cayce Onks, DO

    Penn State Hershey Medical Cen

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Family and Community Medicine and Orthopedics and Rehabilitation

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 13, 2018

Study Start

July 13, 2018

Primary Completion

September 28, 2021

Study Completion

September 28, 2021

Last Updated

March 2, 2022

Results First Posted

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)