Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

Sponsor
The University of Texas Medical Branch, Galveston (Other)
Overall Status
Recruiting
CT.gov ID
NCT03913702
Collaborator
(none)
40
1
2
33.2
1.2

Study Details

Study Description

Brief Summary

The investigators aim to compare subacromial ketorolac (non-steroidal anti-inflammatory drug) versus methylprednisolone (steroid) for the treatment of shoulder impingement syndrome.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ketorolac Tromethamine
  • Drug: Methylprednisolone Acetate
Phase 2

Detailed Description

Because of the current conflicting evidence, the lack of long-term follow-up, and the multiple potential benefit benefits to the society, the investigators aim to compare subacromial ketorolac versus methylprednisolone for the treatment of shoulder impingement syndrome. The investigators hypothesize that patients with shoulder impingement treated with a subacromial methylprednisolone versus ketorolac have similar outcomes based on the ASES (American Shoulder and Elbow Surgeon) self-assessment score. The study will be performed at one institution, the University of Texas Medical Branch.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized clinical trial in which patients will be randomized to receive subacromial injection with either methylprednisolone or ketorolac.Randomized clinical trial in which patients will be randomized to receive subacromial injection with either methylprednisolone or ketorolac.
Masking:
Double (Participant, Investigator)
Masking Description:
Neither the treating physician nor the patient will have access to drug-related details. Data will only be retrieved by the coordinating institution's research coordinator.
Primary Purpose:
Treatment
Official Title:
Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial
Actual Study Start Date :
Sep 9, 2019
Anticipated Primary Completion Date :
May 15, 2022
Anticipated Study Completion Date :
Jun 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ketorolac

Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%)

Drug: Ketorolac Tromethamine
2ml of injectable Ketorolac (30mg/ml) will be mixed with 8ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 60mg of active substance in 10ml).
Other Names:
  • Toradol
  • Active Comparator: Methylprednisolone

    Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)

    Drug: Methylprednisolone Acetate
    1ml of injectable Methylprednisolone (80mg/ml) will be mixed with 9ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 80mg of active substance in 10ml)
    Other Names:
  • DepoMedrol
  • Outcome Measures

    Primary Outcome Measures

    1. American Shoulder and Elbow Surgeon (ASES) [12 weeks]

      The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology.

    Secondary Outcome Measures

    1. American Shoulder and Elbow Surgeon (ASES) [2 weeks]

      The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology.

    2. American Shoulder and Elbow Surgeon (ASES) [4 weeks]

      The ASES is a self-assessment score, ranging between 0 and 100, (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology.

    3. Range of Motion (ROM) [12 weeks]

      The range of motion is a function-related measure, that reflects the extent of shoulder movement (measured in degrees, in forward flexion, and abduction with internal/external rotation of the shoulder)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age >18 years

    • Severe or recalcitrant shoulder impingement syndrome

    • Subacromial injection is a therapeutic option

    Exclusion Criteria:
    • Allergy or intolerance to steroids within less than 1 month

    • Allergy or intolerance to NSAIDs within less than 1 month

    • Pregnancy

    • Breastfeeding

    • Pre-existing asthma

    • Uncontrolled psychiatric illness

    • Previous shoulder injection within the past 3 months

    • Evidence of confounding shoulder pathology on imaging

    • History of a full-thickness rotator cuff tear

    • Ipsilateral cervical radiculopathy

    • Moderate to severe glenohumeral arthritis

    • Systemic inflammatory conditions

    • Kidney disease

    • Liver disease

    • Gastrointestinal ulcer

    • Bleeding disorder

    • Pending litigation or work-related claims related to the shoulder

    • Previous shoulder surgery on the affected shoulder

    • Evidence of local infection

    • Evidence of adhesive capsulitis

    • Evidence of shoulder instability

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universtiy of Texas Medical Branch Galveston Texas United States 77555

    Sponsors and Collaborators

    • The University of Texas Medical Branch, Galveston

    Investigators

    • Principal Investigator: Jeremy Somerson, MD, University of Texas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The University of Texas Medical Branch, Galveston
    ClinicalTrials.gov Identifier:
    NCT03913702
    Other Study ID Numbers:
    • UTMB IRB #: 18-0156
    First Posted:
    Apr 12, 2019
    Last Update Posted:
    Jun 3, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by The University of Texas Medical Branch, Galveston
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 3, 2021