Pain Increases After Shoulder Injection
Primary Purpose
Shoulder Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Methylprednisolone (MPA)
Triamcinolone Acetonide (TA)
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Unable to provide written consent
- Chronic pain syndrome
- Unwilling to complete follow up pain scores (visual analog score)
Sites / Locations
- Campbell Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
methylprednisolone acetate (MPA)
triamcinolone acetonide (TA)
Arm Description
subacromial or glenohumeral shoulder injection
subacromial or glenohumeral shoulder injection
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05438277
Brief Title
Pain Increases After Shoulder Injection
Official Title
Incidence of Flare Reaction Following Shoulder Steroid Injections: Comparison of Depo-medrol (Methylprednisolone) and Kenalog (Triamcinolone)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campbell Clinic
4. Oversight
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
5. Study Description
Brief Summary
Compare FLARE reactions (increase in VAS by two or more points) in the first 48 hours following a shoulder injection.
Detailed Description
Corticosteroid injections are used to reduce pain and inflammation for various shoulder pathologies. Corticosteroid flare reaction is a well-described phenomenon that, despite being self-limited, causes significant pain and dysfunction. A flare reaction is defined for the purposes the study to be an increase of two or more points on a visual analog scale reported by the subject. Currently, there is a paucity of literature to drive the decision-making process between different corticosteroid medications. This study will compare the incidences of steroid flare reaction and three-month efficacy following methylprednisolone acetate (MPA) and triamcinolone acetonide (TA) corticosteroid injections into the glenohumeral joint or subacromial space.
Physicians administering a steroid injection in the shoulder will utilize MPA until 200 subjects have agreed to participate in this treatment arm. Enrollment will then be offered to 200 subjects utilizing TA for the shoulder injection. Subjects receive treatment for their shoulder pain regardless of willingness to participate in the follow up reported pain scores. There are no costs to subjects for study participation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
421 (Actual)
8. Arms, Groups, and Interventions
Arm Title
methylprednisolone acetate (MPA)
Arm Type
Experimental
Arm Description
subacromial or glenohumeral shoulder injection
Arm Title
triamcinolone acetonide (TA)
Arm Type
Active Comparator
Arm Description
subacromial or glenohumeral shoulder injection
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone (MPA)
Other Intervention Name(s)
depomedrol
Intervention Description
injection into subacromial or glenohumeral space with MPA
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide (TA)
Other Intervention Name(s)
kenalog
Intervention Description
injection into subacromial or glenohumeral space with TA
Primary Outcome Measure Information:
Title
Incidence of a Flare Reaction
Description
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.
Time Frame
Post-injection day 1 through 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
Unable to provide written consent
Chronic pain syndrome
Unwilling to complete follow up pain scores (visual analog score)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyler Brolin, MD
Organizational Affiliation
Campbell Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Campbell Clinic
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Pain Increases After Shoulder Injection
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