Osteoarthritis of the Glenohumeral Joint Clinical Trial
Official title:
Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint
| Verified date | June 2021 |
| Source | University of Florida |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 25 |
| Est. completion date | June 6, 2019 |
| Est. primary completion date | June 6, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 100 Years |
| Eligibility | Inclusion Criteria: - Patients with a diagnosis of symptomatic primary osteoarthritis of the shoulder will be recruited from the patient population seeking treatment at the Orthopaedics Sports Medicine Institute. - those who have failed previous treatment including over-the-counter analgesics and activity modification - have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder. Exclusion Criteria: - Patients will be excluded from the study for any of the following reasons: - Post traumatic osteoarthritis - Inflammatory osteoarthritis - Imaging confirmed rotator cuff tear - Prior ipsilateral shoulder surgery - Memory loss or inability to complete study measures - History of allergy to injection medications - Diabetic patients with patient-reported fasting blood glucose >200 - Prior injection in the ipsilateral shoulder within three months |
| Country | Name | City | State |
|---|---|---|---|
| United States | UF and Shands Orthopaedics and Sports Medicine Institute | Gainesville | Florida |
| United States | UF Health Orthopaedics and Sports Medicine Institute | Gainesville | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| University of Florida |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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). | Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months | |
| 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. | Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months | |
| 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) | Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months |