Pain Increases After Shoulder Injection
Incidence of Flare Reaction Following Shoulder Steroid Injections: Comparison of Depo-medrol (Methylprednisolone) and Kenalog (Triamcinolone)
1 other identifier
interventional
421
1 country
1
Brief Summary
Compare FLARE reactions (increase in VAS by two or more points) in the first 48 hours following a shoulder injection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2020
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 24, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedResults Posted
Study results publicly available
March 7, 2023
CompletedMarch 7, 2023
February 1, 2023
2.7 years
June 24, 2022
February 7, 2023
February 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of a Flare Reaction
A flare reaction was defined as an increase of two or more points of Visual Analog Score (VAS) score during the first week following injection. The VAS is a patient reported pain score from zero to ten where zero is no pain and ten is the most pain.
Post-injection day 1 through 7
Study Arms (2)
methylprednisolone acetate (MPA)
EXPERIMENTALsubacromial or glenohumeral shoulder injection
triamcinolone acetonide (TA)
ACTIVE COMPARATORsubacromial or glenohumeral shoulder injection
Interventions
injection into subacromial or glenohumeral space with MPA
injection into subacromial or glenohumeral space with TA
Eligibility Criteria
You may qualify if:
- Subacromial or glenohumeral shoulder pain to be treated with steroid injection
- Fluent in written and oral English
- Willing and able to provide written consent
- Willing to complete follow up pain scores (visual analog score)
You may not qualify if:
- Unable to provide written consent
- Chronic pain syndrome
- Unwilling to complete follow up pain scores (visual analog score)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Campbell Cliniclead
Study Sites (1)
Campbell Clinic
Germantown, Tennessee, 38138, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Research Manager
- Organization
- Campbell Foundation
Study Officials
- PRINCIPAL INVESTIGATOR
Tyler Brolin, MD
Campbell Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 24, 2022
First Posted
June 29, 2022
Study Start
January 1, 2020
Primary Completion
August 31, 2022
Study Completion
September 30, 2022
Last Updated
March 7, 2023
Results First Posted
March 7, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share