84 Participants Needed

Shoulder Injections for Shoulder Osteoarthritis

FA
FA
Overseen ByFidaa Al-Shakfa, M.Sc, MBA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have had a cortisone injection in the last 6 months or a platelet-rich plasma or hyaluronic acid injection in the last 12 months, you cannot participate.

Is the treatment of shoulder osteoarthritis with triamcinolone injections safe?

Research indicates that triamcinolone injections, including extended-release versions, have been evaluated for safety in patients with shoulder osteoarthritis. These studies generally support the safety and tolerability of triamcinolone injections in humans.12345

How does the drug Triamcinolone Hexacetonide combined with hyaluronic acid differ from other treatments for shoulder osteoarthritis?

This drug combination is unique because it combines Triamcinolone Hexacetonide, a steroid that reduces inflammation, with hyaluronic acid, which acts as a lubricant in the joint, potentially offering both pain relief and improved joint function. This dual approach may provide benefits over treatments that use only one of these components.16789

What data supports the effectiveness of the drug for shoulder osteoarthritis?

Research shows that both triamcinolone hexacetonide and hyaluronic acid, components of the treatment, have been used to reduce pain and improve joint function in osteoarthritis of the knee and hand. This suggests they may also help with shoulder osteoarthritis.2371011

Who Is on the Research Team?

PT

Patrice Tétreault, MD FRCSC

Principal Investigator

CHUM

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can read and understand either French or English.
I have arthritis in both shoulders but will choose one side for the study.
The patient must have the cognitive ability to read and fill out the questionnaires
See 3 more

Exclusion Criteria

I do not have any serious health issues that prevent me from joining the study.
I might have or do have an active infection.
Presence of a transfixing rotator cuff tear assessed on MRI
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Pre-infiltration Evaluation

Standard x-ray and MRI examination, demographic data collection, medical history review, and completion of 2 questionnaires

1 week
1 visit (in-person)

Treatment

Participants receive a single intra-articular infiltration of either Cingal or cortisone under fluoroscopy

1 day
1 visit (in-person)

Follow-up

Participants complete electronic questionnaires and maintain a medication diary at 1, 3, and 6 months post-infiltration

6 months
3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Triamcinolone Hexacetonide
  • Triamcinolone Hexacetonide and hyaluronic acid
Trial Overview 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.
How Is the Trial Designed?
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%

Triamcinolone Hexacetonide is already approved in United States, Canada, European Union for the following indications:

🇺🇸
Approved in United States as Aristospan for:
  • Osteoarthritis
  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Bursitis
  • Tendinitis
  • Gouty arthritis
🇨🇦
Approved in Canada as Kenalog for:
  • Osteoarthritis
  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Bursitis
  • Tendinitis
  • Gouty arthritis
🇪🇺
Approved in European Union as Triamcinolone Hexacetonide for:
  • Osteoarthritis
  • Rheumatoid arthritis
  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Bursitis
  • Tendinitis
  • Gouty arthritis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials
389
Recruited
143,000+

Published Research Related to This Trial

In a study of 63 patients with knee osteoarthritis, intra-articular hyaluronic acid (HA) injections showed a trend towards less pain and better outcomes compared to triamcinolone hexacetonide (TH) over a 6-month follow-up period.
Despite the promising results for HA, the study did not find statistically significant differences between HA and TH, indicating that while HA may be a beneficial treatment option, further research is needed to confirm its efficacy over traditional treatments.
Intra-articular hyaluronic acid compared to intra-articular triamcinolone hexacetonide in inflammatory knee osteoarthritis.Jones, AC., Pattrick, M., Doherty, S., et al.[2019]
In a study of 70 patients with primary shoulder osteoarthritis, a single intra-articular injection of hylan G-F 20 (hyaluronic acid) resulted in significant pain reduction and improved range of motion, particularly in those with mild to moderate arthritis, with pain levels decreasing from an average of 8.1 to 4.9 over 6 months.
While both hylan G-F 20 and triamcinolone injections reduced pain and increased patient satisfaction, the effects of hylan G-F 20 appeared to be more effective and longer-lasting compared to triamcinolone.
HYLAN G-F 20 VERSUS TRIAMCINOLONE IN THE TREATMENT OF PRIMARY SHOULDER OSTEOARTHRITIS. RANDOMIZED TRIAL.Tortato, S., Pochini, AC., Andreoli, CV., et al.[2022]
In a study of 60 osteoarthritis patients receiving intra-articular injections, triamcinolone hexacetonide combined with lidocaine significantly reduced joint swelling and decreased the need for pain relief medication over 48 weeks.
However, the treatment did not show any impact on the radiographic progression of osteoarthritis in the injected joints, indicating that while it helps with symptoms, it does not alter the underlying disease progression.
Intra-articular triamcinolone hexacetonide injections in hands osteoarthritis ‒ A double-blinded randomized controlled trial with a one year follow-up.Paschoal, NOS., Natour, J., Machado, FS., et al.[2022]

Citations

Intra-articular hyaluronic acid compared to intra-articular triamcinolone hexacetonide in inflammatory knee osteoarthritis. [2019]
HYLAN G-F 20 VERSUS TRIAMCINOLONE IN THE TREATMENT OF PRIMARY SHOULDER OSTEOARTHRITIS. RANDOMIZED TRIAL. [2022]
Intra-articular triamcinolone hexacetonide injections in hands osteoarthritis ‒ A double-blinded randomized controlled trial with a one year follow-up. [2022]
The intra-articular administration of triamcinolone hexacetonide in the treatment of osteoarthritis. Its effects in a naturally occurring canine osteoarthritis model. [2023]
Clinical evidence in the treatment of rotator cuff tears with hyaluronic acid. [2022]
A double-blind randomized controlled trial comparing the effects of subacromial injection with corticosteroid versus NSAID in patients with shoulder impingement syndrome. [2022]
Safety and Systemic Exposure of Triamcinolone Acetonide Following Ultrasound-Guided Intra-Articular Injection of Triamcinolone Extended-Release or Standard Triamcinolone Acetonide in Patients with Shoulder Osteoarthritis: An Open-Label, Randomized Study. [2023]
Effectiveness of Triamcinolone Hexacetonide Intraarticular Injection in Interphalangeal Joints: A 12-week Randomized Controlled Trial in Patients with Hand Osteoarthritis. [2017]
Subacromial triamcinolone acetonide, hyaluronic acid and saline injections for shoulder pain an RCT investigating the effectiveness in the first days. [2022]
Short-term outcomes of subacromial injection of combined corticosteroid with low-volume compared to high-volume local anesthetic for rotator cuff impingement syndrome: a randomized controlled non-inferiority trial. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Osteo-arthritis of the hip treated by intraneural injection. A simplified technique for the relief of intractable osteo-arthritic pain. [2019]
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