Osteoarthritis of the Glenohumeral Joint
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREintraarticular corticosteroid injections (IACSI)
ultrasound-guided IACSI will be administered
Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder
DEVICEUltrasound
ultrasound-guided IACSI
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ASES Scores at Each Time Point | Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months | 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). |
| Visual Analog Scale Scores at Each Time Point. | Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months | 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. |
| SST (Simple Shoulder Test) Scores at Each Time Point | Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Symptomatic Primary Osteoarthritis of the Shoulder | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 17 Participants | — |
| Age, Categorical Between 18 and 65 years | 8 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 25 participants | — |
| Sex: Female, Male Female | 11 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
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).
Time frame: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months
Population: All participants did not return for all outcome measure time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Symptomatic Primary Osteoarthritis of the Shoulder | ASES Scores at Each Time Point | Baseline ASES score | 48.52 score on a scale | Standard Deviation 13.18 |
| Symptomatic Primary Osteoarthritis of the Shoulder | ASES Scores at Each Time Point | 2 Week ASES score | 79.72 score on a scale | Standard Deviation 23.32 |
| Symptomatic Primary Osteoarthritis of the Shoulder | ASES Scores at Each Time Point | 1 Month ASES scrore | 73.86 score on a scale | Standard Deviation 28.24 |
| Symptomatic Primary Osteoarthritis of the Shoulder | ASES Scores at Each Time Point | 2 Month ASES score | 28.60 score on a scale | Standard Deviation 28.57 |
| Symptomatic Primary Osteoarthritis of the Shoulder | ASES Scores at Each Time Point | 3 Month ASES score | 71.78 score on a scale | Standard Deviation 22.34 |
| Symptomatic Primary Osteoarthritis of the Shoulder | ASES Scores at Each Time Point | 6 Month ASES score | 61.48 score on a scale | Standard Deviation 25.78 |
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)
Time frame: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months
Population: All participants did not return for all outcome measure time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Symptomatic Primary Osteoarthritis of the Shoulder | SST (Simple Shoulder Test) Scores at Each Time Point | Baseline SST Score | 5.29 score on a scale | Standard Deviation 2.46 |
| Symptomatic Primary Osteoarthritis of the Shoulder | SST (Simple Shoulder Test) Scores at Each Time Point | 2 Week SST Score | 8.40 score on a scale | Standard Deviation 2.36 |
| Symptomatic Primary Osteoarthritis of the Shoulder | SST (Simple Shoulder Test) Scores at Each Time Point | 1 Month SST Score | 7.32 score on a scale | Standard Deviation 3.82 |
| Symptomatic Primary Osteoarthritis of the Shoulder | SST (Simple Shoulder Test) Scores at Each Time Point | 2 Month SST Score | 5.92 score on a scale | Standard Deviation 3.43 |
| Symptomatic Primary Osteoarthritis of the Shoulder | SST (Simple Shoulder Test) Scores at Each Time Point | 3 Month SST Score | 6.73 score on a scale | Standard Deviation 3.32 |
| Symptomatic Primary Osteoarthritis of the Shoulder | SST (Simple Shoulder Test) Scores at Each Time Point | 6 Month SST Score | 7.00 score on a scale | Standard Deviation 2.73 |
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.
Time frame: Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months
Population: All participants did not return for all outcome measure time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Symptomatic Primary Osteoarthritis of the Shoulder | Visual Analog Scale Scores at Each Time Point. | Baseline VAS score | 4.54 score on a scale | Standard Deviation 2.62 |
| Symptomatic Primary Osteoarthritis of the Shoulder | Visual Analog Scale Scores at Each Time Point. | Post-injection VAS score | 1.86 score on a scale | Standard Deviation 1.8 |
| Symptomatic Primary Osteoarthritis of the Shoulder | Visual Analog Scale Scores at Each Time Point. | 2 Weeks VAS score | 1.18 score on a scale | Standard Deviation 1.59 |
| Symptomatic Primary Osteoarthritis of the Shoulder | Visual Analog Scale Scores at Each Time Point. | 1 Month VAS score | 2.05 score on a scale | Standard Deviation 2.06 |
| Symptomatic Primary Osteoarthritis of the Shoulder | Visual Analog Scale Scores at Each Time Point. | 2 Month VAS score | 2.56 score on a scale | Standard Deviation 2.97 |
| Symptomatic Primary Osteoarthritis of the Shoulder | Visual Analog Scale Scores at Each Time Point. | 3 Month VAS score | 2.50 score on a scale | Standard Deviation 2.38 |
| Symptomatic Primary Osteoarthritis of the Shoulder | Visual Analog Scale Scores at Each Time Point. | 6 Month VAS score | 2.44 score on a scale | Standard Deviation 3.05 |