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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will compare the analgesic effect of two different types of shoulder injections in patients with osteoarthritis. It is expected that the Cingal injection will provide greater pain relief than a cortisone injection.

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.Check my eligibility

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.See study design

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

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

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

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I am between 20 and 90 years old.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change QuickDash disability/symptoms score

Change in QuickDash Sport/Music score

Change in QuickDash Work score

+2 more

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor

366 Previous Clinical Trials

129,553 Total Patients Enrolled

Patrice Tétreault, MD FRCSCPrincipal InvestigatorCHUM

Media Library

Triamcinolone Hexacetonide (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05408065 — N/A

Shoulder Osteoarthritis Clinical Trial 2023: Triamcinolone Hexacetonide Highlights & Side Effects. Trial Name: NCT05408065 — N/A

Triamcinolone Hexacetonide (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05408065 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for this clinical experiment?

"According to clinicaltrials.gov, this particular trial is no longer enrolling participants; its initial posting was on September 1st 2023 and the most recent update occurred June 3rd 2022. Fortunately, there are 617 other trials that still have open enrollment opportunities at present."

Answered by AI