A Phase 2 interventional study of kenalog and Lidocaine in Humeral Fractures, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by University of Washington · Phase 2, Interventional, and Treatment
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.
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.
175 studies on the registry are indexed under Humeral Fractures; 25 are open to participants now.
This study's enrollment of 9 is below the median of 55 across 99 interventional studies indexed under Humeral Fractures.
Browse Humeral Fractures studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
1.18-90
Exclusion Criteria:
Patients receiving lidocaine
Drug: Lidocaine
Patients receiving Kenalog
Drug: kenalog
Cortisone injection into shoulder
Lidocaine injection into shoulder
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
Visual Analogue Scale
pain scale - high is bad - low is good 0-100
Time frame: 24 weeks
| Milestone | Controls | Cases |
|---|---|---|
| Started | 5 | 4 |
| Completed | 4 | 4 |
| Not completed | 1 | 0 |
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.
| score on a scale | Controls | Cases |
|---|---|---|
| American Shoulder Elbow Society Score | 46 ± 20 | 87 ± 8 |
pain scale - high is bad - low is good 0-100
| units on a scale | Controls | Cases |
|---|---|---|
| Visual Analogue Scale | 4 ± 3.7 | 1 ± 0.8 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Controls | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Cases | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Controls | Cases | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 4 | 9 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Controls | Cases | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 2 | 2 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Controls | Cases | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 5 | 4 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Controls | Cases | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 5 | 4 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Controls | Cases | Total |
|---|---|---|---|
| United States | 5 | 4 | 9 |
| ASES(units on a scale) | Controls | Cases | Total |
|---|---|---|---|
| Mean | 43.4 ± 19.3 | 51.3 ± 5.4 | 46.9 ± 14.9 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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University of Washington