Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
ID05408065

Randomized Trial Comparing Cingal (Sodium Hyaluronate/Triamcinolone) Versus Cortisone (Triamcinolone) Injections for Shoulder Osteoarthritis

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2024-02-12

84

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the pain relief effects of two types of shoulder joint injections for patients with moderate to severe osteoarthritis. The trial compares an injection called Cingal, which combines sodium hyaluronate and triamcinolone, against a standard cortisone injection containing triamcinolone. The study aims to determine if Cingal provides better pain control and functional improvement in the shoulder than cortisone alone. The study involves 84 patients randomly assigned to receive a single injection of either Cingal (4 mL, containing 88 mg of hyaluronic acid and 18 mg of triamcinolone hexacetonide) or cortisone (40 mg of triamcinolone with 4 mL of bupivacaine 0.25%). Before treatment, all participants undergo shoulder X-rays and MRI scans. The injection is performed under fluoroscopy by a radiologist. After treatment, patients complete electronic questionnaires and maintain a medication diary at 1, 3, and 6 months. Participants will be monitored through pain assessments using the visual analogue scale (VAS) at 1, 3, and 6 months after injection, which is the primary outcome at 3 months. Functional ability is evaluated with QuickDash questionnaires at the same time points. Medical history, demographic data, and baseline questionnaires are collected before injection to measure changes over time. The study follows patients for six months to assess both pain relief and shoulder function after treatment.

CONDITIONS

Brief Title

Comparison of the Analgesic Effect of 2 Shoulder Infiltrations

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical examination confirming moderate to severe primary shoulder osteoarthritis, stage II or higher by Samilson-Prieto classification
  • Age between 20 and 90 years
  • If both shoulders affected, patient chooses one side for infiltration
  • Pain level of at least 4 out of 10 on visual analogue scale
  • Ability to read and complete questionnaires
  • Ability to understand French or English
Not Eligible

You will not qualify if you...

  • Transfixing rotator cuff tear shown on MRI
  • Previous shoulder reconstruction surgery
  • Pregnancy
  • Cortisone infiltration within 6 months before study start
  • Platelet-rich plasma or hyaluronic acid infiltration within 12 months before study start
  • Diagnosis of avascular necrosis
  • Diseases affecting the studied joint, such as systemic inflammatory disease, septic arthritis, or osteonecrosis
  • Active or suspected local infection
  • Presence or suspicion of tumor or metastasis in the shoulder
  • Severe shoulder trauma within the last 3 months
  • Significant cognitive impairment or insufficient language skills to complete questionnaires
  • Any serious medical condition preventing study participation or contraindicating cortisone injection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - Single treatment visit

Participants receive a single shoulder infiltration injection of either Cingal (a combination of hyaluronic acid and triamcinolone hexacetonide) or cortisone (triamcinolone) under fluoroscopy.

1 treatment visit (in-person)

Follow-up

Duration - 6 months

Participants complete electronic questionnaires and maintain a medication diary to assess pain and functional abilities over time after the injection.

Questionnaires sent at 1, 3, and 6 months post-injection (remote)

Trial Site Locations

Total: 1 location

1

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada, H2X 0C1

Actively Recruiting

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Research Team

F

Fidaa Al-Shakfa, M.Sc, MBA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial.

Laszlo Hangody, Robert Szody, Piotr Lukasik...

https://pubmed.ncbi.nlm.nih.gov/28535076

Efficacy and safety of Hylan G-F 20 in shoulder osteoarthritis with an intact rotator cuff. Open-label prospective multicenter study.

Eric Noël, Philippe Hardy, Frank-Wolfgang Hagena...

https://pubmed.ncbi.nlm.nih.gov/19945321

A prospective, randomized, double-blind, placebo controlled study to evaluate the efficacy of intraarticular hyaluronic acid for osteoarthritis of the knee.

Robert J Petrella, Michael Petrella

https://pubmed.ncbi.nlm.nih.gov/16652426

Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial.

Robert J Petrella, Pieter J Emans, Julia Alleyne...

https://pubmed.ncbi.nlm.nih.gov/25887932

Combined intra-articular injection of corticosteroid and hyaluronic acid reduces pain compared to hyaluronic acid alone in the treatment of knee osteoarthritis.

Christopher Smith, Rahil Patel, Christopher Vannabouathong...

https://pubmed.ncbi.nlm.nih.gov/30046992

Intra-Articular, Single-Shot Hylan G-F 20 Hyaluronic Acid Injection Compared with Corticosteroid in Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial.

Nattapol Tammachote, Supakit Kanitnate, Thanasak Yakumpor...

https://pubmed.ncbi.nlm.nih.gov/27252432