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Efficacy of Intra-articular NSAID Versus Corticosteroid in the Treatment of Shoulder and Knee Conditions: A Randomized, Double-Blind, Prospective Study

Primary Purpose

Knee Arthritis, Shoulder Arthritis, Shoulder Impingement

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Shoulder injection
knee injection
Sponsored by
OSF Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthritis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • knee and shoulder arthritis
  • shoulder impingement
  • rotator cuff tear

Exclusion Criteria:

  • chronic pain management
  • allergy to NSAIDs or steroids
  • prior surgery
  • kidney disease that would preclude NSAID administration

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Ketorolac

    Kenalog

    Arm Description

    Outcomes

    Primary Outcome Measures

    Pain level: VAS score
    VAS score
    length pain relief
    length of time patient reports pain relief

    Secondary Outcome Measures

    Full Information

    First Posted
    July 31, 2018
    Last Updated
    August 3, 2018
    Sponsor
    OSF Healthcare System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03616340
    Brief Title
    Efficacy of Intra-articular NSAID Versus Corticosteroid in the Treatment of Shoulder and Knee Conditions: A Randomized, Double-Blind, Prospective Study
    Official Title
    Efficacy of Intra-articular NSAID Versus Corticosteroid in the Treatment of Shoulder and Knee Conditions: A Randomized, Double-Blind, Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2018 (Anticipated)
    Primary Completion Date
    August 2019 (Anticipated)
    Study Completion Date
    August 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    OSF Healthcare System

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The proposed study will compare the efficacy of Triamcinolone versus Ketorolac for intra-articular injection of the knee and shoulder
    Detailed Description
    This study will be a randomized prospective study comparing Triamcinolone to Ketorolac for injections in the knee and shoulder for a variety of orthopedic conditions. The investigators will monitor pain relief, length of pain relief, cost, and patient satisfaction after the injections

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Arthritis, Shoulder Arthritis, Shoulder Impingement, Meniscus Lesion, Rotator Cuff Tear, Rotator Cuff Tear Arthropathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ketorolac
    Arm Type
    Experimental
    Arm Title
    Kenalog
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Shoulder injection
    Intervention Description
    intra articular or subacromial shoulder injection
    Intervention Type
    Drug
    Intervention Name(s)
    knee injection
    Intervention Description
    intra-articular knee injection
    Primary Outcome Measure Information:
    Title
    Pain level: VAS score
    Description
    VAS score
    Time Frame
    0-6 months
    Title
    length pain relief
    Description
    length of time patient reports pain relief
    Time Frame
    0-6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: knee and shoulder arthritis shoulder impingement rotator cuff tear Exclusion Criteria: chronic pain management allergy to NSAIDs or steroids prior surgery kidney disease that would preclude NSAID administration
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Miguel ramirez, MD
    Phone
    17857661273
    Email
    maramirez09@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy of Intra-articular NSAID Versus Corticosteroid in the Treatment of Shoulder and Knee Conditions: A Randomized, Double-Blind, Prospective Study

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