Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

Phase 2

Terminated

• Conditions: Subacromial Impingement Syndrome; Subacromial Impingement
• Interventions: Drug: Methylprednisolone Acetate; Drug: Ketorolac Tromethamine

• Registration Number: NCT03913702
• Lead Sponsor: The University of Texas Medical Branch, Galveston

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.

Study Timeline

• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-10
• Study First Posted: 2019-04-12
• Study Start: 2019-09-09
• Primary Completion: 2022-11-02
• Study Completion: 2022-11-02
• Results First Submitted: 2024-05-08
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-23
• Last Update Submitted: 2024-12-23
• Results First Posted: 2025-01-03
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylprednisolone	Methylprednisolone Acetate	Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)
Ketorolac	Ketorolac Tromethamine	Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%)

Primary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeon (ASES)	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. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.

Secondary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeon (ASES)	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. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.
Range of Motion (ROM)	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)

Trial Locations

Locations (1)

Universtiy of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States