Osteoarthritis Shoulder Injection Study
| Status: | Recruiting |
|---|---|
| Conditions: | Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/19/2018 |
| Start Date: | July 13, 2018 |
| End Date: | July 30, 2021 |
| Contact: | Andrea Horne |
| Email: | andreah1115@hotmail.com |
| Phone: | 7176150957 |
Clinical Outcomes Following Randomization of Steroid Concentration in Patients With Glenohumeral Osteoarthritis
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.
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.
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.
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.
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
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