Subacromial Impingement, Subacromial Impingement Syndrome
Conditions
Keywords
Ketorolac, Methylprednisolone, Subacromial impingement syndrome
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.
Interventions
DRUGKetorolac 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).
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)
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.
Intervention model description
Randomized clinical trial in which patients will be randomized to receive subacromial injection with either methylprednisolone or ketorolac.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain. |
| 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) |
Countries
United States
Participant flow
Pre-assignment details
Early termination due to inadequate patient enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Ketorolac Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%)
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). | 1 |
| Methylprednisolone Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%)
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) | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Ketorolac | Methylprednisolone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
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. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.
Time frame: 12 weeks
Population: No data collected.
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. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.
Time frame: 2 weeks
Population: No data collected.
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. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.
Time frame: 4 weeks
Population: No data collected.
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)
Time frame: 12 weeks
Population: No data collected.