Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

Sponsor

The University of Texas Medical Branch, Galveston (Other)

Overall Status

Recruiting

CT.gov ID

NCT03913702

Collaborator

(none)

Enrollment

Location

Arms

33.2

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Subacromial Impingement Subacromial Impingement Syndrome	Drug: Ketorolac Tromethamine Drug: Methylprednisolone Acetate	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Investigator)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 9, 2019

Anticipated Primary Completion Date :

May 15, 2022

Anticipated Study Completion Date :

Jun 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ketorolac Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%)	Drug: 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). Other Names: Toradol
Active Comparator: Methylprednisolone Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)	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) Other Names: DepoMedrol

Arm

Intervention/Treatment

Active Comparator: Ketorolac

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

Drug: 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).

Other Names:

Toradol

Active Comparator: Methylprednisolone

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

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)

Other Names:

DepoMedrol

Outcome Measures

Primary Outcome Measures

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.

Secondary Outcome Measures

American Shoulder and Elbow Surgeon (ASES) [2 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.
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.
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)