Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

March 3, 2023 updated by: The University of Texas Medical Branch, Galveston

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks
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.
4 weeks
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)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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