Shoulder Injections for Shoulder Osteoarthritis

Overseen By Fidaa Al-Shakfa, M.Sc, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Rotator cuff tear, Pregnancy, Avascular necrosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 1 day

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to relieve pain from shoulder osteoarthritis by comparing two treatments: a traditional cortisone injection (Triamcinolone Hexacetonide) and a new combination injection called Cingal, which includes both cortisone and a gel-like substance for joints. The researchers aim to determine if Cingal provides better pain relief than cortisone alone. Individuals with moderate to severe shoulder osteoarthritis who experience significant pain and can complete a questionnaire might be suitable for this study. As an unphased trial, this study allows participants to contribute to innovative pain relief research for shoulder osteoarthritis.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cingal, a combination of sodium hyaluronate and triamcinolone, is generally well-tolerated. In a study with 642 participants who received Cingal injections, the treatment proved safe. Another study demonstrated that Cingal significantly relieved osteoarthritis pain, with effects lasting up to 26 weeks. This indicates that the treatment has undergone thorough testing and is considered safe.

Triamcinolone, used in cortisone treatments, is already a common and well-known option for pain relief in osteoarthritis, widely used to reduce inflammation and pain. When comparing both treatments, research supports their safety, but Cingal may provide longer-lasting relief. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard treatments for shoulder osteoarthritis, which often involve separate injections of cortisone or hyaluronic acid, the new treatment, Cingal, combines these two components into a single injection. This combination is unique because it merges the anti-inflammatory power of triamcinolone hexacetonide with the joint-lubricating benefits of hyaluronic acid. Researchers are excited because this dual-action approach has the potential to provide more comprehensive relief by reducing inflammation and improving joint mobility simultaneously. Additionally, the convenience of a single injection could enhance patient compliance and comfort.

What evidence suggests that this trial's treatments could be effective for shoulder osteoarthritis?

Research has shown that Cingal, a combination of hyaluronic acid and the steroid triamcinolone hexacetonide, can quickly and effectively relieve osteoarthritis pain. One study found that Cingal's benefits lasted up to 26 weeks compared to a placebo. In this trial, some participants will receive Cingal, which might be more effective than cortisone alone, especially for ongoing pain and stiffness. The hyaluronic acid in Cingal cushions and lubricates joints, enhancing the relief provided by the steroid. These findings suggest that Cingal could offer longer-lasting pain relief for people with shoulder osteoarthritis. ^{1 2 6 7 8}

Who Is on the Research Team?

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

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.

I have been diagnosed with avascular necrosis.

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?

Group I: Cingal Experimental Treatment 1 Intervention

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

Group II: Cortisone Active Control 1 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

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 32 patients with external shoulder impingement syndrome, ketorolac injections led to significantly greater improvements in shoulder function and patient satisfaction compared to triamcinolone injections after 4 weeks.

Both treatments were effective in reducing pain and improving range of motion, but ketorolac showed superior results in the UCLA shoulder rating scale, suggesting it may be a safer alternative to corticosteroids with fewer potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind randomized controlled trial comparing the effects of subacromial injection with corticosteroid versus NSAID in patients with shoulder impingement syndrome. Min, KS., St Pierre, P., Ryan, PM., et al.[2022]

In a study of 159 patients with subacromial impingement, triamcinolone acetonide injections provided the most significant pain relief within the first week compared to hyaluronic acid and sodium chloride injections.

The study found that while the first and second triamcinolone acetonide injections led to substantial pain reduction, the third injection offered only minimal additional benefit, suggesting that more than two injections may not be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subacromial triamcinolone acetonide, hyaluronic acid and saline injections for shoulder pain an RCT investigating the effectiveness in the first days. Penning, LI., de Bie, RA., Walenkamp, GH.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 involving 52 patients with shoulder impingement syndrome, low-volume corticosteroid injections (4 cc) provided similar pain relief and functional outcomes compared to high-volume injections (10 cc), indicating that less medication can be just as effective.

Both injection methods resulted in significant pain reduction over time, with no statistically significant differences in outcomes, suggesting that low-volume injections may be a safer and more efficient option for treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Boonard, M., Sumanont, S., Arirachakaran, A., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Intraarticular injection of triamcinolone hexacetonide (TH) combined with lidocaine (LD) significantly improved pain during movement and reduced joint swelling in patients with osteoarthritis of the hand interphalangeal joints compared to lidocaine alone, with results observed as early as one week after treatment.

The study involved 60 patients, primarily women with an average age of 60.7 years, and found no significant adverse effects from the treatment, indicating that TH/LD is a safe and effective option for managing symptoms of osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Triamcinolone Hexacetonide Intraarticular Injection in Interphalangeal Joints: A 12-week Randomized Controlled Trial in Patients with Hand Osteoarthritis. Spolidoro Paschoal, Nde O., Natour, J., Machado, FS., et al.[2017]

Intra-articular administration of triamcinolone hexacetonide (THG) significantly improved weight distribution and pain scores in patients over a period of 180 days compared to saline, with notable improvements starting as early as 8 days post-treatment.

The study involved 40 hip joints in children with a mean age of 6.5 years, and THG showed better outcomes in joint function and thermographic evaluations, indicating its efficacy in managing joint issues, although factors like age and radiographic findings influenced treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The intra-articular administration of triamcinolone hexacetonide in the treatment of osteoarthritis. Its effects in a naturally occurring canine osteoarthritis model. Alves, JC., Santos, A., Jorge, P., et al.[2023]

Intra-articular injection of hyaluronic acid (HA) significantly reduces pain and improves function in patients with rotator cuff tears, based on a systematic review of 11 studies involving 1102 patients.

The review found no severe adverse reactions associated with HA injections, indicating that it is a safe treatment option compared to corticosteroid injections and other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evidence in the treatment of rotator cuff tears with hyaluronic acid. Osti, L., Buda, M., Buono, AD., et al.[2022]

A new treatment for hip osteoarthritis using an intraneural injection of Triamcinolone Hexacetonide shows better results than traditional systemic or intra-articular steroid methods.

This method provides rapid relief from muscle spasms and pain, supporting findings from previous studies that highlight its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Osteo-arthritis of the hip treated by intraneural injection. A simplified technique for the relief of intractable osteo-arthritic pain. Pybus, PK.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 phase 2 study involving 25 patients with shoulder osteoarthritis, triamcinolone acetonide extended-release (TA-ER) demonstrated a lower systemic exposure compared to the crystalline suspension (TAcs), suggesting a potentially improved safety profile for TA-ER.

Both formulations were well-tolerated, with no serious adverse events reported, indicating that TA-ER may provide effective treatment with reduced risk of systemic side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Hanson, P., Kivitz, A., Mehra, P., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04640961

Study of Cingal® for Symptomatic Relief of Osteoarthritis ... This Trial will obtain clinical data to support an expanded indication for a single injection of Cingal used for the symptomatic relief of osteoarthritis in the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05408065

NCT05408065 | Comparison of the Analgesic Effect of 2 ... The objective is to compare the analgesic effect of 2 infiltrations: Cingal (sodium hyaluronate and triamcinolone) versus cortisone (triamcinolone). It is ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28535076/

Intraarticular Injection of a Cross-Linked Sodium ... Cingal provides immediate and long-term relief of osteoarthritis-related pain, stiffness, and function, significant through 26 weeks compared to saline.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05408065/comparison-of-the-analgesic-effect-of-2-shoulder-infiltrations

Comparison of the Analgesic Effect of 2 Shoulder Infiltrations The objective is to compare the analgesic effect of 2 infiltrations: Cingal (sodium hyaluronate and triamcinolone) versus cortisone (triamcinolone).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7941755/

Recent Advances in Clinical Translation of Intra-Articular ... Anika Therapeutics is developing an injectable, cross-linked HA gel loaded with triamcinolone hexacetonide (TH) for IA therapy of OA (Cingal). This product is ...

6. cingal.com cingal.com/for-physicians/clinical-evidence/

Clinical Evidence - Cingal The results of the Cingal 13-01 study confirm the safety and effectiveness of a single intra-articular injection of Cingal for rapid and long-term relief of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2059775424002104

Intra-articular injection of a cross-linked hyaluronic acid ... The objective of this study was to assess the use of a hyaluronic acid and corticosteroid-based injection (Cingal™; Anika Therapeutics, Bedford, MA, USA) in ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/61/NCT04640961/Prot_000.pdf

Cingal 20-02 Cingal® studies generated a safety data base of 642 subjects treated intra-articularly with a CingalR injection, including 94 subjects retreated ...