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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) vas score at 1 month 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 belowSelect...
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 1 month after the infiltration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline (preinfiltration visit) quickdash score at 1 month after the infiltration
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 moreAwards & 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%
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.
Gait patterns after intraarticular treatment of patients with osteoarthritis of the knee--hyaluronan versus triamcinolone: a prospective, randomized, doubleblind, monocentric study.
Find a Location
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,296 Total Patients Enrolled
Patrice Tétreault, MD FRCSCPrincipal InvestigatorCHUM
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious health issues that prevent me from joining the study.I can read and understand either French or English.I might have or do have an active infection.I have been diagnosed with avascular necrosis.My joint condition is not due to systemic inflammation, infection, or bone death.I have arthritis in both shoulders but will choose one side for the study.I have not had a cortisone shot in the last 6 months.My pain level is at least a 4 out of 10.I am between 20 and 90 years old.I have not had treatments with platelet-rich plasma or hyaluronic acid in the last year.I have had a severe shoulder injury in the last 3 months.My shoulder pain is due to severe arthritis, confirmed by both a doctor's exam and X-rays.I have not had shoulder reconstruction surgery.I might have cancer or cancer that has spread locally.I have arthritis in both shoulders but will choose one side for the study.My pain level is at least a 4 out of 10.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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