Clinical trial NCT03913702: Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement
Official title: Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Subacromial Impingement
Subacromial Impingement Syndrome
Keywords: Ketorolac
Methylprednisolone
Subacromial impingement syndrome
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial in which patients will be randomized to receive subacromial injection with either methylprednisolone or ketorolac.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: American Shoulder and Elbow Surgeon (ASES)
timeFrame: 12 weeks
Secondary outcomes:
measure: American Shoulder and Elbow Surgeon (ASES)
timeFrame: 2 weeks
measure: American Shoulder and Elbow Surgeon (ASES)
timeFrame: 4 weeks
measure: Range of Motion (ROM)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Universtiy of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Jeremy Somerson, MD
role: PRINCIPAL_INVESTIGATOR
References: