Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-09

Study Completion Date

2022-11-02

Brief Summary

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

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Detailed Description

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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.

Conditions

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Subacromial Impingement Subacromial Impingement Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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Ketorolac

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

Group Type ACTIVE_COMPARATOR

Ketorolac Tromethamine

Intervention Type 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).

Methylprednisolone

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

Group Type ACTIVE_COMPARATOR

Methylprednisolone Acetate

Intervention Type 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)

Interventions

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Ketorolac Tromethamine

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).

Intervention Type DRUG

Methylprednisolone Acetate

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)

Intervention Type DRUG

Other Intervention Names

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Toradol DepoMedrol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No