Pain Increases After Shoulder Injection

February 7, 2023 updated by: Tyler J. Brolin, Campbell Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

421

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Campbell Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: methylprednisolone acetate (MPA)
subacromial or glenohumeral shoulder injection
Drug: Methylprednisolone (MPA)
injection into subacromial or glenohumeral space with MPA
Other Names:
  • depomedrol
Active Comparator: triamcinolone acetonide (TA)
subacromial or glenohumeral shoulder injection
Drug: Triamcinolone Acetonide (TA)
injection into subacromial or glenohumeral space with TA
Other Names:
  • kenalog

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-injection day 1 through 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campbell Clinic

Investigators

  • Principal Investigator: Tyler Brolin, MD, Campbell Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

June 24, 2022

First Posted (Actual)

June 29, 2022

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 7001-XP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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