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Osteoarthritis Shoulder Injection Study

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ClinicalTrials.gov Identifier: NCT03586687
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Cayce Onks, Milton S. Hershey Medical Center

Brief Summary:
The purpose of this study is to determine the most effective intraarticular steroid dose for the treatment of glenohumeral osteoarthritis. We 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. Our objectives 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). We 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.

Condition or disease Intervention/treatment Phase
Glenohumeral Osteoarthritis Drug: Triamcinolone Phase 4

Detailed Description:

Osteoarthritis (OA) affects 54.4 million US adults and 23.7 million (43.5%) have arthritis-attributable activity limitation1. 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 injection2. 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 injection3,4.

Unfortunately, data on intraarticular injections is not robust and primarily focused on hip, knee, and disease processes rather than the glenohumeral joint6-8. 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 two6. When a placebo was ad¬¬ded, both doses were better than the placebo, but once again no difference was seen between the two steroid concentrations7. Another study, looking at knee osteoarthritis, found that high dose steroids had a larger effect on duration8, but other studies have shown no difference in duration between the 40mg and 80mg concentration of triamcinolone acetonide9.

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 rare10,11. 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 glucose11. 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 cataracts11. 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 loss11,12.

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 evidence13. 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Outcomes Following Randomization of Steroid Concentration in Patients With Glenohumeral Osteoarthritis
Estimated Study Start Date : July 2, 2018
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2021


Arm Intervention/treatment
Active Comparator: Group 1
20mg Triamcinolone with 3cc of 1% Lidocaine
Drug: Triamcinolone
Ultrasound guided glenohumeral shoulder joint injection

Active Comparator: Group 2
40mg Triamcinolone with 3cc of 1% Lidocaine
Drug: Triamcinolone
Ultrasound guided glenohumeral shoulder joint injection

Active Comparator: Group 3
80mg Triamcinolone with 3cc of 1% Lidocaine
Drug: Triamcinolone
Ultrasound guided glenohumeral shoulder joint injection




Primary Outcome Measures :
  1. Change in Overall SPADI scores at baseline compared to 2,4, and 6 months. [ Time Frame: baseline, 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

  2. Assess reactions to the steroid [ Time Frame: baseline, 2, 4, and 6 months ]
    Adverse events will only include those that are determined to be related to steroid


Secondary Outcome Measures :
  1. Rate of Shoulder Arthroplasty following injection [ Time Frame: 12 months ]
    Shoulder arthroplasty is defined as total shoulder replacement

  2. Change in overall SPADI scores for those receiving Shoulder Arthroplasty at 1 year [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586687


Contacts
Contact: Andrea Horne 7176150957 andreah1115@hotmail.com

Locations
United States, Pennsylvania
Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Andrea Horne    717-531-7127    ahorne@pennstatehealth.psu.edu   
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Cayce Onks, DO Penn State Hershey Medical Cen

Responsible Party: Cayce Onks, Assistant Professor of Family and Community Medicine and Orthopedics and Rehabilitation, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03586687     History of Changes
Other Study ID Numbers: 00008490
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Cayce Onks, Milton S. Hershey Medical Center:
Ultrasound guided injection

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action