Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

NCT03913702 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: UTMB IRB #: 18-0156
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Subacromial Impingement; Subacromial Impingement Syndrome

Keywords

Ketorolac; Methylprednisolone; Subacromial impingement syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• American Shoulder and Elbow Surgeon (ASES)

  2 weeks

• American Shoulder and Elbow Surgeon (ASES)

  4 weeks

• Range of Motion (ROM)

  12 weeks

Study Arms (2)

Ketorolac

ACTIVE COMPARATOR

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

Drug: Ketorolac Tromethamine

Methylprednisolone

ACTIVE COMPARATOR

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

Drug: Methylprednisolone Acetate

Interventions

Ketorolac Tromethamine DRUG

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).

Also known as: Toradol

Ketorolac

Methylprednisolone Acetate DRUG

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)

Also known as: DepoMedrol

Methylprednisolone

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Severe or recalcitrant shoulder impingement syndrome
• Subacromial injection is a therapeutic option

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

Universtiy of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Ketorolac Tromethamine; Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

The protocol was terminated early due inadequate patient enrollment.

Results Point of Contact

• Title: Dr. Jeremy Somerson
• Organization: University of Texas Medical Branch Galveston

jesomers@utmb.edu

409-747-5701

Study Officials

• Jeremy Somerson, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial in which patients will be randomized to receive subacromial injection with either methylprednisolone or ketorolac.

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 12, 2019
• Study Start: September 9, 2019
• Primary Completion: November 2, 2022
• Study Completion: November 2, 2022
• Last Updated: January 3, 2025
• Results First Posted: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 20 weeks from the last patient enrollment
• Access Criteria: At the end of this investigation, all results will be tabulated and submitted to clinicaltrials.gov to report.

Locations

US (1)