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| ID | Type | Description | Link |
|---|---|---|---|
| OCR18320 | Other Identifier | University of Florida |
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The physician in charge is leaving the University of Florida
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This study will examine the effectiveness of a single cortisone injection in patients with shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors to help predict how a patient with shoulder osteoarthritis will respond to a cortisone injection utilizing ultrasound guidance.
The purpose of this study is to assess the effectiveness of intraarticular corticosteroid injections (IACSI) for glenohumeral arthritis by 1) through patient-reported outcomes and 2) identifying clinical and radiographic predictors of IACSI success.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| symptomatic primary osteoarthritis of the shoulder | Other | Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraarticular corticosteroid injections (IACSI) | Procedure | ultrasound-guided IACSI will be administered |
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| Measure | Description | Time Frame |
|---|---|---|
| ASES Scores at Each Time Point | ASES (American Shoulder & Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better). | Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months |
| Visual Analog Scale Scores at Each Time Point. | VAS (Visual Analog Scale) pain score improvement > 1.4 points (The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0=no pain and 10=worst pain). The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0=no pain and 10=worst pain. | Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months |
| SST (Simple Shoulder Test) Scores at Each Time Point | SST (Simple Shoulder Test) score improvement > 2.4 points. 12 items that are answered yes/no (measures functional limitations of the affected shoulder): Scored: 0-12 (Higher score is better) | Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley Schoch, M.D. | Faculty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF and Shands Orthopaedics and Sports Medicine Institute | Gainesville | Florida | 32611 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Symptomatic Primary Osteoarthritis of the Shoulder | Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder Ultrasound: ultrasound-guided IACSI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2018 |
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| corticosteroid injections | Drug | Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder |
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| Ultrasound | Device | ultrasound-guided IACSI |
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| UF Health Orthopaedics and Sports Medicine Institute |
| Gainesville |
| Florida |
| 32611 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Symptomatic Primary Osteoarthritis of the Shoulder | Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder Ultrasound: ultrasound-guided IACSI |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | ASES Scores at Each Time Point | ASES (American Shoulder & Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better). | All participants did not return for all outcome measure time points | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months |
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| Primary | Visual Analog Scale Scores at Each Time Point. | VAS (Visual Analog Scale) pain score improvement > 1.4 points (The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0=no pain and 10=worst pain). The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0=no pain and 10=worst pain. | All participants did not return for all outcome measure time points | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months |
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| Primary | SST (Simple Shoulder Test) Scores at Each Time Point | SST (Simple Shoulder Test) score improvement > 2.4 points. 12 items that are answered yes/no (measures functional limitations of the affected shoulder): Scored: 0-12 (Higher score is better) | All participants did not return for all outcome measure time points | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months |
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6 months
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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 | Symptomatic Primary Osteoarthritis of the Shoulder | Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder intraarticular corticosteroid injections (IACSI): ultrasound-guided IACSI will be administered corticosteroid injections: Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder Ultrasound: ultrasound-guided IACSI | 0 | 25 | 0 | 25 | 0 | 25 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MaryBeth Horodyski, Ed.D., ATC, LAT, FNATA | University of Florida | 352-273-7074 | horodmb@ortho.ufl.edu |
| Jan 8, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 2, 2017 | Jan 8, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D000077555 | Methylprednisolone Acetate |
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| >=65 years |
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| 1 Month ASES scrore |
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| 2 Month ASES score |
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| 3 Month ASES score |
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| 6 Month ASES score |
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