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Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

Primary Purpose

Subacromial Impingement, Subacromial Impingement Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketorolac Tromethamine
Methylprednisolone Acetate
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement focused on measuring Ketorolac, Methylprednisolone, Subacromial impingement syndrome

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universtiy of Texas Medical Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ketorolac

Methylprednisolone

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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)

Full Information

First Posted
April 10, 2019
Last Updated
March 3, 2023
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT03913702
Brief Title
Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement
Official Title
Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Inadequate patient enrollment
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
November 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement, Subacromial Impingement Syndrome
Keywords
Ketorolac, Methylprednisolone, Subacromial impingement syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial in which patients will be randomized to receive subacromial injection with either methylprednisolone or ketorolac.
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac
Arm Type
Active Comparator
Arm Description
Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%)
Arm Title
Methylprednisolone
Arm Type
Active Comparator
Arm Description
Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)
Intervention Type
Drug
Intervention Name(s)
Ketorolac Tromethamine
Other Intervention Name(s)
Toradol
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone Acetate
Other Intervention Name(s)
DepoMedrol
Intervention Description
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)
Primary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeon (ASES)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeon (ASES)
Description
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.
Time Frame
2 weeks
Title
American Shoulder and Elbow Surgeon (ASES)
Description
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.
Time Frame
4 weeks
Title
Range of Motion (ROM)
Description
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)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Somerson, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universtiy of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

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