Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

Subacromial Impingement Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03913702
• Other study ID #: UTMB IRB #: 18-0156
• Status: Terminated
• Phase: Phase 2
• Start date: September 9, 2019
• Est. completion date: November 2, 2022

Study information

• Verified date: March 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 2, 2022
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Subacromial Impingement
• Subacromial Impingement Syndrome

Intervention

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).
• 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)

Locations

Country	Name	City	State
United States	Universtiy of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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.	2 weeks
Secondary	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.	4 weeks
Secondary	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)	12 weeks