Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial

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

Study Overview

• Status: Terminated
• Conditions: Subacromial Impingement Syndrome; Subacromial Impingement
• Intervention / Treatment: Drug: Ketorolac Tromethamine; Drug: Methylprednisolone Acetate

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • Universtiy of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeon (ASES)	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. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion (ROM)	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)	12 weeks
American Shoulder and Elbow Surgeon (ASES)	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. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.	2 weeks
American Shoulder and Elbow Surgeon (ASES)	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. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.	4 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Jeremy Somerson, MD, University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): November 2, 2022
• Study Completion (Actual): November 2, 2022

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Subacromial impingement syndrome; Methylprednisolone; Ketorolac
• Additional Relevant MeSH Terms: Shoulder Injuries; Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Shoulder Impingement Syndrome; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Protective Agents; Neuroprotective Agents; Methylprednisolone Acetate; Ketorolac; Prednisolone; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Ketorolac Tromethamine
• Other Study ID Numbers: UTMB IRB #: 18-0156

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: At the end of this investigation, IPD-related results will be tabulated and submitted to clinicaltrials.gov to report. This would help evaluate the effects and safety of interventions administered.
• IPD Sharing Time Frame: 20 weeks from the last patient enrollment
• IPD Sharing Access Criteria: At the end of this investigation, all results will be tabulated and submitted to clinicaltrials.gov to report.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

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