Humeral Fractures
Conditions
Brief summary
The objective of this project is to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.
Detailed description
THis is a randomized control trial to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.
Interventions
DRUGkenalog
Cortisone injection into shoulder
DRUGLidocaine
Lidocaine injection into shoulder
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1.18-90 2\. Proximal Humerus Fracture 3\. Decreased range of motion at 6 wk follow-up 4\. Likely to be available for follow up for 26 wks
Exclusion criteria
1. Known drug allergy to kenalog or lidocaine 2. Unable to complete functional outcome 3. Pregnant Women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder Elbow Society Score | 24 weeks | Outcome Instrument high is good low is bad 0-100 The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | 24 weeks | pain scale - high is bad - low is good 0-100 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Controls Patients receiving lidocaine
Lidocaine: Lidocaine injection into shoulder | 5 |
| Cases Patients receiving Kenalog
kenalog: Cortisone injection into shoulder | 4 |
| Total | 9 |
Baseline characteristics
| Characteristic | Controls | Cases | 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 | 5 Participants | 4 Participants | 9 Participants |
| ASES | 43.4 units on a scale STANDARD_DEVIATION 19.3 | 51.3 units on a scale STANDARD_DEVIATION 5.4 | 46.9 units on a scale STANDARD_DEVIATION 14.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 4 Participants | 9 Participants |
| Region of Enrollment United States | 5 participants | 4 participants | 9 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
Primary
American Shoulder Elbow Society Score
Outcome Instrument high is good low is bad 0-100 The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Controls | American Shoulder Elbow Society Score | 46 score on a scale | Standard Deviation 20 |
| Cases | American Shoulder Elbow Society Score | 87 score on a scale | Standard Deviation 8 |
Secondary
Visual Analogue Scale
pain scale - high is bad - low is good 0-100
Time frame: 24 weeks
Population: Population at 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Controls | Visual Analogue Scale | 4 units on a scale | Standard Deviation 3.7 |
| Cases | Visual Analogue Scale | 1 units on a scale | Standard Deviation 0.8 |