What side effects are associated with this type of intervention?

The most common treatments for shoulder osteoarthritis, such as Sodium Hyaluronate and Triamcinolone, have known side effects. Sodium Hyaluronate injections can cause transient bruising, discomfort, edema, and erythema at the injection site. In rare cases, hypersensitivity reactions and infections may occur. Triamcinolone, a corticosteroid, can lead to side effects such as joint infection, post-injection flare (temporary worsening of symptoms), and potential weakening of tendons and ligaments with repeated use. Both treatments aim to provide pain relief and improve joint function, but patients should discuss potential risks with their healthcare provider.

What prior FDA approvals exist?

The FDA has approved various treatments for shoulder osteoarthritis that involve components similar to those in Cingal. Sodium hyaluronate, a form of hyaluronic acid, has been approved for intraarticular injections to provide joint lubrication and cushioning, commonly used in knee osteoarthritis but also applicable to other joints like the shoulder. Triamcinolone, a corticosteroid, is approved for its anti-inflammatory and analgesic effects in treating joint pain and inflammation. These treatments aim to provide temporary relief from pain and improve joint function.

What other types of research exist?

Promising novel alternatives to Cingal for shoulder osteoarthritis patients include: 1) Hyaluronic acid combined with ozone gas, which has shown potential in treating osteoarthritis in animal studies. 2) Advanced formulations of hyaluronic acid, such as those with higher molecular weight or cross-linking, which may offer improved joint lubrication and longer-lasting effects. 3) Combination therapies involving hyaluronic acid and other anti-inflammatory agents, which could provide synergistic benefits.

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Corticosteroid

Shoulder Injections for Shoulder Osteoarthritis

N/A

Recruiting

Led By Patrice Tétreault, MD FRCSC

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Suspicion or presence of active local infectious process

Diagnosis of avascular necrosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline (preinfiltration visit) quickdash score at 3 months after the infiltration

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two types of injections for shoulder osteoarthritis. It targets patients with moderate to severe pain and limited mobility. One injection combines a lubricating substance with an anti-inflammatory drug, while the other uses only an anti-inflammatory drug. The goal is to see which injection provides better pain relief and improves joint function. Diclofenac etalhyaluronate (DF-HA) has been studied for its effectiveness and safety in treating osteoarthritis in various joints, showing significant pain relief particularly in the hip joint.

Who is the study for?

This trial is for adults aged 20-90 with moderate to severe primary shoulder osteoarthritis, who can read and understand French or English. They must have pain of at least 4/10 on the visual scale and be able to fill out questionnaires. Exclusions include those with certain shoulder injuries, recent related treatments, pregnancy, joint diseases like avascular necrosis or infections, cognitive impairments that prevent questionnaire comprehension.

What is being tested?

The study compares two types of shoulder injections for pain relief in osteoarthritis: one combining Cingal (sodium hyaluronate and triamcinolone) versus just cortisone (triamcinolone). It's a randomized controlled trial where participants are chosen by sealed envelopes to determine which treatment they receive.

What are the potential side effects?

Potential side effects may include reactions at the injection site such as pain, swelling or infection; systemic effects from cortisone like elevated blood sugar levels; allergic reactions; and possibly worsening of joint inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have arthritis in both shoulders but will choose one side for the study.

Select...

My pain level is at least a 4 out of 10.

Select...

I am between 20 and 90 years old.

Select...

My shoulder pain is due to severe arthritis, confirmed by both a doctor's exam and X-rays.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I might have or do have an active infection.

Select...

I have been diagnosed with avascular necrosis.

Select...

My joint condition is not due to systemic inflammation, infection, or bone death.

Select...

I have not had shoulder reconstruction surgery.

Select...

I might have cancer or cancer that has spread locally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline (preinfiltration visit) quickdash score at 3 months after the infiltration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline (preinfiltration visit) quickdash score at 3 months after the infiltration

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (preinfiltration visit) quickdash score at 3 months after the infiltration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change QuickDash disability/symptoms score

Change in QuickDash Sport/Music score

Change in QuickDash Work score

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CingalExperimental Treatment1 Intervention

A single infiltration of Cingal, 4 mL, 88 of mg hyaluronic acid and 18 mg of triamcinolone hexacetonide

Group II: CortisoneActive Control1 Intervention

A single infiltration of cortisone, 40mg of triamcinolone and 4mL of bupivacaine 0.25%

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for shoulder osteoarthritis include sodium hyaluronate and triamcinolone. Sodium hyaluronate acts by lubricating and cushioning the joint, which helps to improve joint mobility and reduce pain. Triamcinolone, a corticosteroid, provides anti-inflammatory and analgesic effects, reducing inflammation and pain in the affected joint. These mechanisms are crucial for shoulder OA patients as they directly address the symptoms of pain and limited mobility, thereby improving the quality of life and functional ability of the patients.

Gait patterns after intraarticular treatment of patients with osteoarthritis of the knee--hyaluronan versus triamcinolone: a prospective, randomized, doubleblind, monocentric study.