Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

Phase 2TerminatedNCT03913702

The University of Texas Medical Branch, Galveston1 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Subacromial Impingement Subacromial Impingement Syndrome

Interventions

Ketorolac TromethamineDRUG

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).

Methylprednisolone AcetateDRUG

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Universtiy of Texas Medical Branch

Galveston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Secondary Outcomes

American Shoulder and Elbow Surgeon (ASES)

Time frame: 2 weeks

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.

Time frame: 4 weeks

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)

Time frame: 12 weeks

Data from ClinicalTrials.gov

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