- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03913702
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
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 Locations
-
-
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%)
|
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:
|
Active Comparator: Methylprednisolone
Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)
|
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:
|
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.
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
Additional Relevant MeSH Terms
- Wounds and Injuries
- Joint Diseases
- Musculoskeletal Diseases
- Shoulder Injuries
- Shoulder Impingement Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- Ketorolac
- 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
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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