Clinical trial NCT05438277
Conditions: Shoulder Pain
Sponsor: Campbell Clinic
Start date: 2020-01-01; Completion date: 2022-09-30
Enrollment: 421 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: subacromial or glenohumeral shoulder injection arm 2: subacromial or glenohumeral shoulder injection
Interventions: intervention 1: Methylprednisolone (MPA) intervention 2: Triamcinolone Acetonide (TA)
Intervention descriptions: intervention 1: injection into subacromial or glenohumeral space with MPA intervention 2: injection into subacromial or glenohumeral space with TA

Protocol documents:
Prot_SAP_000.pdf: 
4.28.2020 
 
Flare Study Protocol 
PI: Tyler James Brolin, MD 
Co-Investigators: Frederick Azar, MD, Thomas Throckmorton, MD, and David Bernholt, MD 
Research Staff: Myles Joyce BS, Renn Eason BS, MS, Margaret Knack RN, CCRP 
 
1. Purpose 
Triamcinolone acetate (TA) and methylprednisolone acetate (MA) are standard of care (SOC) 
medications administered in shoulder injections depending upon Physician preference.  The Physicians 
involved in the study have observed a difference in the rate of call backs following shoulder injection due 
to a reported increase in shoulder pain following the SOC injection.  The purpose of this study is to 
compare the incidence of a flare reaction following administration of TA versus MA intra-articular 
glenohumeral and subacromial injections.   
For the study, a flare reaction is defined as an increase of 2 or more from the baseline score on the visual 
analog score (VAS) in the first week following the shoulder injection.   
2. Patient Enrollment 
The study is a non-randomized, prospective, parallel-cohort study among subjects treated according to 
standard of care. Subjects will be approached for participation after electing to receive a corticosteroid 
injection in the glenohumeral joint or subacromial space as part of their SOC treatment plan.   Three 
months was allotted for enrollment into the MA cohort followed by three months of enrollment into the 
TA cohort.   
3. Inclusion Criteria 
Any patient aged 18 to 95 who pursues a corticosteroid injection in the glenohumeral joint or subacromial 
space from one of three primary orthopedic Sports medicine or Shoulder specialists.  
4. Exclusion Criteria 
Patients will be excluded if they have received a corticosteroid injection in the previous three months. 
 
  


4.28.2020 
 
5. Outcome Measures 
The primary outcome measure is the incidence of a Flare reaction. 
Secondary measures include VAS scores collected at the three-month time point. Another secondary 
measure is “treatment failure,” defined as a VAS score equal to or greater than a subject’s baseline VAS 
score. Subjects that proceed to another injection or surgery will also be defined as “treatment failures.” 
6. Study Procedures 
The consent form will be utilized to explain the study design to prospective subjects in a private room.  
Adequate time will be allotted for questions and answers with the study team.  The pre-injection VAS 
will be administered in clinic. VAS scores for the week following injection will be obtained through a 
“home diary” data collection tool labeled with a subject code. After completing the “home diary” tool, 
patients will mail the stamped, form to the study administrator. The three-, six-, and twelve-month VAS 
scores will be collected by phone interviews with research staff.  
7. Statistical Analysis Plan 
Data will be collected and summarized by research staff. Advanced statistical analysis will be performed, 
including risk ratios for flare reaction development by cohort as well as standard and adjusted regression 
models.  
8. Risk to Subjects 
Subjects may experience tiresome or troublesome feelings while completing VAS scores through the 
“home diary” or phone interviews with research staff.   Loss of confidentiality is a potential risk disclosed 
to subjects.   
9. Benefit to Subjects 
There are no direct benefits to subjects outside of the possible benefits of the SOC procedures being 
studied.  However, the findings from the study may contribute to generalizable knowledge as assist with 
decision making practices at Campbell Clinic.  
10. Subject Discontinuation 
Subjects will not be contacted for subsequent study procedures if the subject withdraws from the study or 
if they are determined to have “failed” treatment.  
11. Adverse Events 


4.28.2020 
 
No incidental adverse advents are expected as all study procedures are currently SOC. 
 
12. Data Handling, Collection, and Record Keeping 
Baseline VAS scores will be collected in clinic prior to injection. “Home diaries” will be mailed by 
subjects to research personnel in a manner that protects study confidentiality. Three-month VAS scores 
will be obtained through phone interviews conducted by research personnel. All data will be combined 
into a secure, password-protected electronic data capture (EDC) tool.