Glenohumeral Osteoarthritis
Conditions
Keywords
Ultrasound guided injection
Brief summary
The purpose of this study is to determine the most effective intraarticular steroid dose for the treatment of glenohumeral osteoarthritis. The investigators aim to randomize patients into low, medium, and high dose groups of injectable corticosteroids as these doses are typically used in the standard of care for our patients. To date there has been no study to evaluate which dose is most efficient with the fewest side effects for glenohumeral osteoarthritis. The investigators objective will be to provide ultrasound guided intraarticular glenohumeral injections of these randomized concentrations and to evaluate pain and function before and following injection with the Shoulder Pain and Disability Index (SPADI). The investigators hypothesize that the low dose steroid will provide equivalent improvement of the pain and function to the medium and high doses, while minimizing side effects.
Detailed description
Osteoarthritis (OA) affects 54.4 million US adults and 23.7 million (43.5%) have arthritis-attributable activity limitation. As the condition progresses, pain and functional disability increase. Patients usually begin treatment with conservative measures including physical therapy and administration of nonsteroidal anti-inflammatory drugs before obtaining a corticosteroid injection. Corticosteroid injections have a patient-specific duration that often provide relief for a month before the effects begin to taper with most individuals returning to baseline by 2-3 months post injection. Unfortunately, data on intraarticular injections is not robust and primarily focused on hip, knee, and disease processes rather than the glenohumeral joint. For example, steroid concentrations have been studied in adhesive capsulitis, where 20 and 40mg of triamcinolone acenotide were used with no statistical significance between the two. When a placebo was added, both doses were better than the placebo, but once again no difference was seen between the two steroid concentrations. Another study, looking at knee osteoarthritis, found that high dose steroids had a larger effect on duration, but other studies have shown no difference in duration between the 40mg and 80mg concentration of triamcinolone acetonide. Intraarticular injections do have adverse effects. Similar to steroids taken orally or intravenously, intraarticular injections have a similar side effect profile. Fortunately, intraarticular injections are localized, by the nature of the procedure, and the chances of experiencing a significant side effect is rare. The most common side effects are steroid flare, allergic reaction, facial erythema, hypo-pigmentation, fat pad necrosis, cutaneous atrophy, and a transient increase in blood glucose. Some of the rare side effects have been seen in case reports include idiopathic central serous chorioretinopathy, decrease in breast milk production, sepsis, tendon rupture, and cataracts. In addition, the administration of steroid injections are limited to being done every three months due to risk of weakening tendons, and acceleration of cartilage loss. There is a void of literature for understating the ideal injectable steroid concentrations in glenohumeral osteoarthritis. Because of this, providers who perform intraarticular injections tend to perform them based on prior training experience or anecdotal evidence. We aim to evaluate the ideal steroid concentration that will maximize treatment effect for glenohumeral osteoarthritis, but at the same time minimize side effects, and better train our future providers.
Interventions
Ultrasound guided glenohumeral shoulder joint injection
Sponsors
Study design
Eligibility
Inclusion criteria
* An X-ray within a year with Radiographic evidence of OA * 18 years of age or older * Clinical diagnosis established due to symptoms that will include pain attributed to glenohumeral osteoarthritis, pain with range of motion, and/or functional limitations longer than 3 months.
Exclusion criteria
* Previous guided steroid injection of the glenohumeral joint within 3 months * Previous diagnosis of inflammatory arthritis, rotator cuff tear, or immunocompromised * Previous shoulder surgery * Allergy to steroid or lidocaine * A Kellgren and Lawrence classification of 1 or less on radiograph * Non-English Speaking * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. | baseline, 2, 4, and 6 months. Baseline SPADI score was collected prior to injection. | The Shoulder Pain and Disability Index (SPADI) measures current shoulder pain and disability using a 13 item assessment. Scores range from 0-100 with higher scores indicating greater impairment or disability |
| Assess Reactions to the Steroid | baseline, 2, 4, and 6 months. Baseline data was collected at 2wks post injection phone call. | Adverse events will only include those that are determined to be related to steroid Adverse Reactions to the Steroid are reported as combined for all the participants and not at the per-participant level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Shoulder Arthroplasty Following Injection | 12 months | Shoulder arthroplasty is defined as total shoulder replacement |
| Change in Overall SPADI Scores for Those Receiving Shoulder Arthroplasty at 1 Year | 12 months | The Shoulder Pain and Disability Index (SPADI) measures current shoulder pain and disability using a 13 item assessment. Scores range from 0-100 with higher scores indicating greater impairment or disability |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 20 mg 20mg Triamcinolone with 3cc of 1% Lidocaine
Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection | 6 |
| 40 mg 40mg Triamcinolone with 3cc of 1% Lidocaine
Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection | 9 |
| 80 mg 80mg Triamcinolone with 3cc of 1% Lidocaine
Triamcinolone: Ultrasound guided glenohumeral shoulder joint injection | 4 |
| Total | 19 |
Baseline characteristics
| Characteristic | 20 mg | 40 mg | 80 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 63.67 years STANDARD_DEVIATION 12.26 | 69.33 years STANDARD_DEVIATION 6.93 | 64.50 years STANDARD_DEVIATION 12.29 | 66.53 years STANDARD_DEVIATION 9.79 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 1 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 9 | 0 / 4 |
| other Total, other adverse events | 1 / 6 | 2 / 9 | 0 / 4 |
| serious Total, serious adverse events | 0 / 6 | 0 / 9 | 0 / 4 |
Outcome results
Assess Reactions to the Steroid
Adverse events will only include those that are determined to be related to steroid Adverse Reactions to the Steroid are reported as combined for all the participants and not at the per-participant level.
Time frame: baseline, 2, 4, and 6 months. Baseline data was collected at 2wks post injection phone call.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 20 mg Triamcinolone With 3cc of 1% Lidocaine | Assess Reactions to the Steroid | 6 month follow up | 0 Reactions |
| 20 mg Triamcinolone With 3cc of 1% Lidocaine | Assess Reactions to the Steroid | 4 month follow up | 0 Reactions |
| 20 mg Triamcinolone With 3cc of 1% Lidocaine | Assess Reactions to the Steroid | 2 month follow up | 0 Reactions |
| 20 mg Triamcinolone With 3cc of 1% Lidocaine | Assess Reactions to the Steroid | Baseline | 1 Reactions |
| 40 mg Triamcinolone With 3cc of 1% Lidocaine | Assess Reactions to the Steroid | 2 month follow up | 0 Reactions |
| 40 mg Triamcinolone With 3cc of 1% Lidocaine | Assess Reactions to the Steroid | 6 month follow up | 0 Reactions |
| 40 mg Triamcinolone With 3cc of 1% Lidocaine | Assess Reactions to the Steroid | Baseline | 2 Reactions |
| 40 mg Triamcinolone With 3cc of 1% Lidocaine | Assess Reactions to the Steroid | 4 month follow up | 0 Reactions |
| 80 mg Triamcinolone With 3cc of 1% Lidocaine | Assess Reactions to the Steroid | 6 month follow up | 0 Reactions |
| 80 mg Triamcinolone With 3cc of 1% Lidocaine | Assess Reactions to the Steroid | Baseline | 0 Reactions |
| 80 mg Triamcinolone With 3cc of 1% Lidocaine | Assess Reactions to the Steroid | 4 month follow up | 0 Reactions |
| 80 mg Triamcinolone With 3cc of 1% Lidocaine | Assess Reactions to the Steroid | 2 month follow up | 0 Reactions |
Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months.
The Shoulder Pain and Disability Index (SPADI) measures current shoulder pain and disability using a 13 item assessment. Scores range from 0-100 with higher scores indicating greater impairment or disability
Time frame: baseline, 2, 4, and 6 months. Baseline SPADI score was collected prior to injection.
Population: Difference in subjects analyzed for all arms was due to the need of subsequent treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 20 mg Triamcinolone With 3cc of 1% Lidocaine | Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. | Baseline SPADI Score | 58.17 score on a scale | Standard Deviation 17.88 |
| 20 mg Triamcinolone With 3cc of 1% Lidocaine | Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. | 2 month SPADI Score | 30.60 score on a scale | Standard Deviation 22.6 |
| 20 mg Triamcinolone With 3cc of 1% Lidocaine | Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. | 4 month SPADI Score | 44.80 score on a scale | Standard Deviation 30.11 |
| 20 mg Triamcinolone With 3cc of 1% Lidocaine | Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. | 6 month SPADI Score | 44.60 score on a scale | Standard Deviation 25.6 |
| 40 mg Triamcinolone With 3cc of 1% Lidocaine | Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. | 6 month SPADI Score | 57.71 score on a scale | Standard Deviation 18.62 |
| 40 mg Triamcinolone With 3cc of 1% Lidocaine | Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. | Baseline SPADI Score | 60.67 score on a scale | Standard Deviation 17.91 |
| 40 mg Triamcinolone With 3cc of 1% Lidocaine | Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. | 4 month SPADI Score | 51.12 score on a scale | Standard Deviation 27.53 |
| 40 mg Triamcinolone With 3cc of 1% Lidocaine | Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. | 2 month SPADI Score | 48.67 score on a scale | Standard Deviation 22.01 |
| 80 mg Triamcinolone With 3cc of 1% Lidocaine | Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. | 6 month SPADI Score | 26.00 score on a scale | Standard Deviation 7.07 |
| 80 mg Triamcinolone With 3cc of 1% Lidocaine | Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. | 2 month SPADI Score | 22.25 score on a scale | Standard Deviation 19.97 |
| 80 mg Triamcinolone With 3cc of 1% Lidocaine | Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. | 4 month SPADI Score | 35.67 score on a scale | Standard Deviation 34.43 |
| 80 mg Triamcinolone With 3cc of 1% Lidocaine | Change in Overall SPADI Scores at Baseline Compared to 2,4, and 6 Months. | Baseline SPADI Score | 44.50 score on a scale | Standard Deviation 18.34 |
Change in Overall SPADI Scores for Those Receiving Shoulder Arthroplasty at 1 Year
The Shoulder Pain and Disability Index (SPADI) measures current shoulder pain and disability using a 13 item assessment. Scores range from 0-100 with higher scores indicating greater impairment or disability
Time frame: 12 months
Population: Subjects who underwent shoulder arthroplasty by/at 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 20 mg Triamcinolone With 3cc of 1% Lidocaine | Change in Overall SPADI Scores for Those Receiving Shoulder Arthroplasty at 1 Year | 2 score on a scale |
| 40 mg Triamcinolone With 3cc of 1% Lidocaine | Change in Overall SPADI Scores for Those Receiving Shoulder Arthroplasty at 1 Year | 12 score on a scale |
| 80 mg Triamcinolone With 3cc of 1% Lidocaine | Change in Overall SPADI Scores for Those Receiving Shoulder Arthroplasty at 1 Year | 4 score on a scale |
Rate of Shoulder Arthroplasty Following Injection
Shoulder arthroplasty is defined as total shoulder replacement
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 20 mg Triamcinolone With 3cc of 1% Lidocaine | Rate of Shoulder Arthroplasty Following Injection | 3 Participants |
| 40 mg Triamcinolone With 3cc of 1% Lidocaine | Rate of Shoulder Arthroplasty Following Injection | 1 Participants |
| 80 mg Triamcinolone With 3cc of 1% Lidocaine | Rate of Shoulder Arthroplasty Following Injection | 1 Participants |