Pain Increases After Shoulder Injection

Phase 4

Completed

• Conditions: Shoulder Pain
• Interventions: Drug: Methylprednisolone (MPA); Drug: Triamcinolone Acetonide (TA)

• Registration Number: NCT05438277
• Lead Sponsor: Campbell Clinic

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-06-24
• Study First Posted: 2022-06-29
• Primary Completion: 2022-08-31
• Study Completion: 2022-09-30
• Status Verified: 2023-02
• Results First Submitted: 2023-02-07
• Results First Submitted QC: 2023-02-07
• Last Update Submitted: 2023-02-07
• Results First Posted: 2023-03-07
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 421

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methylprednisolone acetate (MPA)	Methylprednisolone (MPA)	subacromial or glenohumeral shoulder injection
triamcinolone acetonide (TA)	Triamcinolone Acetonide (TA)	subacromial or glenohumeral shoulder injection

Primary Outcome Measures

Name	Time	Method
Incidence of a Flare Reaction	Post-injection day 1 through 7	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.

Trial Locations

Locations (1)

Campbell Clinic; 🇺🇸 Germantown, Tennessee, United States