Comparison of the Analgesic Effect of 2 Shoulder Infiltrations

Study Overview
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Brief Summary
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For patients suffering of osteoarthritis, only analgesic treatments such as anti-inflammatory drugs and cortisone infiltrations provide significant but temporary relief of their pain. The objective is to compare the analgesic effect of 2 infiltrations: Cingal (sodium hyaluronate and triamcinolone) versus cortisone (triamcinolone). It is anticipated that the Cingal infiltration will have a greater analgesic effect than a simple cortisone infiltration in patients with moderate to severe osteoarthritis of the shoulder. Method: Randomized controlled trial Monocentric Randomization will be done using sealed envelopes

Detailed Description
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Osteoarthritis is a degenerative joint disease. The progressive erosion of cartilage generates inflammation, pain, and progressive deterioration of joint mobility. Synthetic molecules similar to hyaluronic acid have made it possible to offer patients the option of visco-supplementation by intra-articular injection. It decreases inflammation and pain. CINGAL (Anika Therapeutics, Inc., Bedford, MA), which combines the lubricating action of hyaluronic acid and the anti-inflammatory action of triamcinolone hexacetonide, is one of the available treatments. Several studies have demonstrated the effectiveness of hyaluronic acid in the relief of gonarthrosis. However, the efficacy between an infiltration of hyaluronic acid combined with triamcinolone and a corticosteroid infiltration for glenohumeral osteoarthritis is hardly reviewed in scientific studies. Primary objective: To compare the analgesic effect of two different infiltrations. Secondary outcome: To evaluate the patient's functional ability It is anticipated that a CINGAL infiltration will have a greater beneficial effect than a simple cortisone infiltration in patients with mild to severe shoulder OA. 84 patients with moderate to severe shoulder osteoarthritis will be recruited to receive intra-articular infiltration of CINGAL or cortisone. The infiltration will be randomly assigned. A standard x-ray and magnetic resonance imaging examination will be performed before the infiltration. Demographic data, medical history and 2 questionnaires will be completed prior to infiltration. Once the evaluation is completed, the patient is randomized and referred to radiology to receive his infiltration under fluoroscopy by a radiologist assigned to the project. Two electronic questionnaires and a medication diary will be sent to the patient at 1, 3 and 6 months post-infiltration.

Official Title
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A Randomized Single-blinded Clinical Trial of the Efficacy of Intra-articular Infiltration of Cingal (Sodium Hyaluronate/Triamcinolone) Versus Cortisone (Triamcinolone) in Patients With Osteoarthritis of the Shoulder.

Conditions
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Infiltration, Shoulder Osteoarthritis

Intervention / Treatment
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* Drug: Triamcinolone Hexacetonide and hyaluronic acid
* Drug: Triamcinolone Hexacetonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A clinical examination that confirms the radiological diagnosis of moderate to severe primary shoulder osteoarthritis, stage II and above, according to the Samilson-Prieto classification. Patients aged between 20 and 90 years. A patient with bilateral shoulder osteoarthritis will choose the side of the infiltration, only one side can be chosen to participate in the study. The patient must have a clinical pain threshold of a minimum of 4/10 on the visual analogue scale. The patient must have the cognitive ability to read and fill out the questionnaires. The patient must be able to read and understand French or English Exclusion Criteria: Presence of a transfixing rotator cuff tear assessed on MRI. No previous shoulder reconstruction surgery. Pregnant woman. A patient who has received a cortisone infiltration within 6 months prior to the start of the study. A patient who has received a platelet-rich plasma or a hyaluronic acid infiltration within 12 months prior to the start of the study. Diagnosis of avascular necrosis. Disease affecting the studied joint (systemic inflammatory disease, history of septic arthritis, osteonecrosis, etc.) Suspicion or presence of active local infectious process. Presence or suspicion of neoplasia or local metastasis. Severe trauma to the shoulder ( ≤ 3 months) Significant cognitive impairment or insufficient language proficiency to adequately answer the questionnaires. Any other serious medical condition that does not allow participation in the study or may be a contraindication to cortisone injection.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cingal<br>A single infiltration of Cingal, 4 mL, 88 of mg hyaluronic acid and 18 mg of triamcinolone hexacetonide | Drug: Triamcinolone Hexacetonide and hyaluronic acid<br>* infiltration under fluoroscopy<br>* Other names: Cingal;|
| Active Comparator: Cortisone<br>A single infiltration of cortisone, 40mg of triamcinolone and 4mL of bupivacaine 0.25% | Drug: Triamcinolone Hexacetonide<br>* infiltration under fluoroscopy<br>* Other names: Cortisone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VAS score | Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst possible pain | Change from baseline (preinfiltration visit) VAS score at 3 months after the infiltration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in VAS score | Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst possible pain | Change from baseline (preinfiltration visit) VAS score at 1 month after the infiltration | 
| Change in VAS score | Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst pain | Change from baseline (preinfiltration visit) VAS score at 6 months after the infiltration | 
| Change in QuickDash disability/symptoms score | QuickDash; 0-100 scale, 0: no difficulties 100: unable | Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration | 
| Change in QuickDash disability/symptoms score | QuickDash; 0-100 scale, 0: no difficulties 100: unable | Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration | 
| Change QuickDash disability/symptoms score | QuickDash; 0-100 scale, 0: no difficulties 100: unable | Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration | 
| Change in QuickDash Work score | QuickDash; 0-100 scale, 0: no difficulties 100: unable | Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration | 
| Change in QuickDash Work score | QuickDash; 0-100 scale, 0: no difficulties 100: unable | Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration | 
| Change in QuickDash Work score | QuickDash; 0-100 scale, 0: no difficulties 100: unable | Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration | 
| Change in QuickDash Sport/Music score | QuickDash; 0-100 scale, 0: no difficulties 100: unable | Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration | 
| Change in QuickDash Sport/Music score | QuickDash; 0-100 scale, 0: no difficulties 100: unable | Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration | 
| Change in QuickDash Sport/Music score | QuickDash; 0-100 scale, 0: no difficulties 100: unable | Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infiltration, Osteoarthritis, hyaluronic acid