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Pain Increases After Shoulder Injection

Sponsor
Campbell Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05438277
Collaborator
(none)
400
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Methylprednisolone (MPA)
  • Drug: Triamcinolone Acetonide (TA)
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Incidence of Flare Reaction Following Shoulder Steroid Injections: Comparison of Depo-medrol (Methylprednisolone) and Kenalog (Triamcinolone)
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual Analog Score [postinjection day one]

      patient reported pain score from zero to ten where zero is no pain and ten is the most pain

    2. Visual Analog Score [postinjection day two]

      patient reported pain score from zero to ten where zero is no pain and ten is the most pain

    3. Visual Analog Score [postinjection day three]

      patient reported pain score from zero to ten where zero is no pain and ten is the most pain

    4. Visual Analog Score [postinjection day three month]

      patient reported pain score from zero to ten where zero is no pain and ten is the most pain

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Campbell Clinic Germantown Tennessee United States 38138

    Sponsors and Collaborators

    • Campbell Clinic

    Investigators

    • Principal Investigator: Tyler Brolin, MD, Campbell Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tyler J. Brolin, Principal Investigator, Campbell Clinic
    ClinicalTrials.gov Identifier:
    NCT05438277
    Other Study ID Numbers:
    • IRB 7001-XP
    First Posted:
    Jun 29, 2022
    Last Update Posted:
    Jul 5, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Shoulder Pain
    Methylprednisolone
    Methylprednisolone Acetate
    Triamcinolone
    Triamcinolone Acetonide
    Triamcinolone hexacetonide
    Triamcinolone diacetate

    Study Results

    No Results Posted as of Jul 5, 2022