Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

The University of Texas System (UT)

Status and phase: Terminated; Phase 2

Conditions: Subacromial Impingement; Subacromial Impingement Syndrome

Treatments: Drug: Methylprednisolone Acetate; Drug: Ketorolac Tromethamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03913702

UTMB IRB #: 18-0156

Details and patient eligibility

About

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

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 2 patient groups

Ketorolac

Active Comparator group

Description:

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

Treatment:

Drug: Ketorolac Tromethamine

Methylprednisolone

Active Comparator group

Description:

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

Treatment:

Drug: Methylprednisolone Acetate