Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial

UTMB IRB #: 18-0156

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

2019-09-09

2022-11-02

2022-11-02

Terminated

Early phase I

1

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized clinical trial in which patients will be randomized to receive subacromial injection with either methylprednisolone or ketorolac.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "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.", 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 1, 'type': 'ACTUAL'}}

2023-03-07