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NCT04278833

Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions

Terminated Phase 4 Results posted Last updated 12 February 2025
What this trial tests

Phase 4 trial testing Triamcinolone or Betamethasone in Osteoarthritis in 165 participants. Terminated before completion.

Timeline
1 September 2020
Primary endpoint
28 May 2021
28 May 2021

Quick facts

Lead sponsorStanford University
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment165
Start date1 September 2020
Primary completion28 May 2021
Estimated completion28 May 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Stanford University

Who can join

18 and older, any sex, with Osteoarthritis or Tendinopathy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change in Average Pain From Baseline Primary · Baseline and at 2 weeks, 3 months, and 6 months post intervention

Mean change in pain averaged over last 7 days compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes.

Baseline
GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site6.0± 2.1
Particulate Corticosteroid Injection - Hip Injection Site5.1± 3.1
Non-particulate Corticosteroid Injection - Shoulder Injection Site5.9± 2.2
Non-particulate Corticosteroid Injection - Hip Injection Site5.0± 3.3
2 weeks
GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site-2.9± 2.0
Particulate Corticosteroid Injection - Hip Injection Site-2.0± 2.5
Non-particulate Corticosteroid Injection - Shoulder Injection Site-1.5± 2.0
Non-particulate Corticosteroid Injection - Hip Injection Site-1.8± 2.3
3 months
GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site-1.8± 2.6
Particulate Corticosteroid Injection - Hip Injection Site-1.8± 3.3
Non-particulate Corticosteroid Injection - Shoulder Injection Site-2.2± 2.3
Non-particulate Corticosteroid Injection - Hip Injection Site0.5± 0.7
6 months
GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site-1.6± 2.7
Particulate Corticosteroid Injection - Hip Injection Site-0.9± 3.1
Non-particulate Corticosteroid Injection - Shoulder Injection Site-2.1± 2.7
Non-particulate Corticosteroid Injection - Hip Injection Site-0.5± 0.7
Number of Participants With ≥50% Decrease in Pain From Baseline Primary · Baseline and at 2 weeks, 3 months, and 6 months post intervention

Decrease in pain compared to baseline as rated on 11 point numerical rating scale (NRS, score range from 0-10) with higher values indicating worse outcomes.

2 weeks
GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site4
Particulate Corticosteroid Injection - Hip Injection Site3
Non-particulate Corticosteroid Injection - Shoulder Injection Site13
Non-particulate Corticosteroid Injection - Hip Injection Site3
3 months
GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site6
Particulate Corticosteroid Injection - Hip Injection Site3
Non-particulate Corticosteroid Injection - Shoulder Injection Site18
Non-particulate Corticosteroid Injection - Hip Injection Site0
6 months
GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site8
Particulate Corticosteroid Injection - Hip Injection Site2
Non-particulate Corticosteroid Injection - Shoulder Injection Site13
Non-particulate Corticosteroid Injection - Hip Injection Site0
Change in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index Secondary · Baseline and at 2 weeks, 3 months, and 6 months post intervention

The WOMAC questionnaire will be used for participants who underwent hip injection. The outcome of interest is the mean change in score compared to baseline. The WOMAC is a 24 item scale with scores ranging from 0 to 96, with higher scores indicating worse outcomes.

Baseline
GroupValue95% CI
Particulate Corticosteroid Injection - Hip Injection Site64.3± 24.8
Non-particulate Corticosteroid Injection - Hip Injection Site62.3± 15.5
Change at 2 weeks
GroupValue95% CI
Particulate Corticosteroid Injection - Hip Injection Site-18.6± 15.3
Non-particulate Corticosteroid Injection - Hip Injection Site-10.3± 12.1
Change at 3 months
GroupValue95% CI
Particulate Corticosteroid Injection - Hip Injection Site-14.4± 16.8
Non-particulate Corticosteroid Injection - Hip Injection Site-4.0± 10.1
Change at 6 months
GroupValue95% CI
Particulate Corticosteroid Injection - Hip Injection Site-14.1± 15.1
Non-particulate Corticosteroid Injection - Hip Injection Site-1.0± 11.0
Change in Quick Disabilities of Arm, Shoulder, and Hand (QDASH) Secondary · Baseline and at 2 weeks, 3 months, and 6 months post intervention

The QDASH questionnaire will be used for participants who underwent glenohumeral joint, subdeltoid bursa, or peritendinous biceps injection. The outcome of interest is the mean change in score compared to baseline. The QDASH is an 11 item scale with scores ranging from 0 to 100, with higher scores indicating worse outcomes.

Baseline
GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site41.9± 22.8
Non-particulate Corticosteroid Injection - Shoulder Injection Site49.0± 21.8
Change at 2 weeks
GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site-15.7± 12.2
Non-particulate Corticosteroid Injection - Shoulder Injection Site-11.4± 13.2
Change at 3 months
GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site-9.1± 12.3
Non-particulate Corticosteroid Injection - Shoulder Injection Site-17.1± 16.6
Change at 6 months
GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site-15.5± 16.4
Non-particulate Corticosteroid Injection - Shoulder Injection Site-21.0± 21.5
Change in American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment Form Secondary · Baseline and at 2 weeks, 3 months, and 6 months post intervention

The ASES questionnaire will be used for participants who underwent glenohumeral joint, subdeltoid bursa, or peritendinous biceps injection. The outcome of interest is the mean change in score compared to baseline. The ASES is an 11 item scale with scores ranging from 0 to 100, with higher scores indicating better outcomes.

Baseline
GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site62.9± 19.7
Non-particulate Corticosteroid Injection - Shoulder Injection Site61.5± 19.2
Change at 2 weeks
GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site18.0± 12.7
Non-particulate Corticosteroid Injection - Shoulder Injection Site12.8± 14.5
Change at 3 months
GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site14.1± 18.1
Non-particulate Corticosteroid Injection - Shoulder Injection Site20.3± 20.8
Change at 6 months
GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site18.1± 22.1
Non-particulate Corticosteroid Injection - Shoulder Injection Site23.9± 26.2
Number of Participants With Repeat Corticosteroid Injections Secondary · 6 months post initial intervention

Total number of corticosteroid injections to the specific anatomical site during the study period. The study protocol allows for a maximum of 3 injections during the 6 month study period based on the treating physician's discretion.

GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site6
Particulate Corticosteroid Injection - Hip Injection Site2
Non-particulate Corticosteroid Injection - Shoulder Injection Site2
Non-particulate Corticosteroid Injection - Hip Injection Site1
Number of Participants Referred for Surgical Intervention (Conversion to Surgery) Secondary · 6 months post initial intervention

Number (%) of participants who were referred for surgical intervention on the specific anatomical site during the study follow up period.

GroupValue95% CI
Particulate Corticosteroid Injection - Shoulder Injection Site6
Particulate Corticosteroid Injection - Hip Injection Site2
Non-particulate Corticosteroid Injection - Shoulder Injection Site1
Non-particulate Corticosteroid Injection - Hip Injection Site2

Sponsor's own description

This aims of this study are: 1. To determine if particulate or non-particulate corticosteroid injections are more effective at treating pain from musculoskeletal pathologies of the hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa at 2 weeks, 3 months, or 6 months. 2. To determine if there is a significantly different side effect profile between particulate and non-particulate corticosteroids when used for hip, glenohumeral joint, biceps tendon, or subacromial/subdeltoid bursa injections.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04278833.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing