Pain Increases After Shoulder Injection

Campbell Clinic

Status and phase: Completed; Phase 4

Conditions: Shoulder Pain

Treatments: Drug: Triamcinolone Acetonide (TA); Drug: Methylprednisolone (MPA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05438277

IRB 7001-XP

Details and patient eligibility

About

Compare FLARE reactions (increase in VAS by two or more points) in the first 48 hours following a shoulder injection.

Full 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.

Enrollment: 421 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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421 participants in 2 patient groups

methylprednisolone acetate (MPA)

Experimental group

Description:

subacromial or glenohumeral shoulder injection

Treatment:

Drug: Methylprednisolone (MPA)

triamcinolone acetonide (TA)

Active Comparator group

Description:

subacromial or glenohumeral shoulder injection

Treatment:

Drug: Triamcinolone Acetonide (TA)