Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

Overview

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

Full Title of Study: “Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 15, 2022

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.

Interventions

  • 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).
  • 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)

Arms, Groups and Cohorts

  • Active Comparator: Ketorolac
    • Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%)
  • Active Comparator: Methylprednisolone
    • Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)

Clinical Trial Outcome Measures

Primary Measures

  • American Shoulder and Elbow Surgeon (ASES)
    • Time Frame: 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 Measures

  • American Shoulder and Elbow Surgeon (ASES)
    • Time Frame: 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.
  • American Shoulder and Elbow Surgeon (ASES)
    • Time Frame: 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.
  • Range of Motion (ROM)
    • Time Frame: 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Medical Branch, Galveston
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jeremy Somerson, MD, Principal Investigator, University of Texas
  • Overall Contact(s)
    • Marc El Beaino, MD, MSc, 409-747-3207, maelbeai@utmb.edu

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