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Completed

NCT Number: NCT05438277

Pain Increases After Shoulder Injection

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

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Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Campbell Clinic

Germantown, Tennessee, 38138, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Methylprednisolone (MPA)

Drug

injection into subacromial or glenohumeral space with MPA

Other names: depomedrol

Triamcinolone Acetonide (TA)

Drug

injection into subacromial or glenohumeral space with TA

Other names: kenalog

Primary outcomes

  1. Incidence of a Flare Reaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Campbell Clinic

Other

Registry information

Official study title

Incidence of Flare Reaction Following Shoulder Steroid Injections: Comparison of Depo-medrol (Methylprednisolone) and Kenalog (Triamcinolone)

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 29, 2022
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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