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| ID | Type | Description | Link |
|---|---|---|---|
| P30AR072572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controls | Placebo Comparator | Patients receiving lidocaine |
|
| Cases | Active Comparator | Patients receiving Kenalog |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| kenalog | Drug | Cortisone injection into shoulder |
| |
| Lidocaine |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale | pain scale - high is bad - low is good 0-100 | 24 weeks |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Jonah Hebert-Davies, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Controls | Patients receiving lidocaine Lidocaine: Lidocaine injection into shoulder |
| FG001 | Cases | Patients receiving Kenalog kenalog: Cortisone injection into shoulder |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Controls | Patients receiving lidocaine Lidocaine: Lidocaine injection into shoulder |
| BG001 | Cases | Patients receiving Kenalog kenalog: Cortisone injection into shoulder |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Controls | Patients receiving lidocaine Lidocaine: Lidocaine injection into shoulder |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonah Hebert-Davies | University of Washington | 2067443466 | jdavies2@uw.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 16, 2018 | Aug 31, 2023 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 11, 2019 | Feb 2, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006810 | Humeral Fractures |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
Lidocaine injection into shoulder |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ASES | American Shoulder Elbow Society Score The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder.0 (worst-100 (best) | Mean | Standard Deviation | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Visual Analogue Scale | pain scale - high is bad - low is good 0-100 | Population at 24 weeks | Posted | Mean | Standard Deviation | units on a scale | 24 weeks |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Cases | Patients receiving Kenalog kenalog: Cortisone injection into shoulder | 0 | 4 | 0 | 4 | 0 | 4 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |