Comparing two types of shoulder injections for osteoarthritis pain relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the analgesic effects of two different shoulder infiltrations: Cingal, which combines sodium hyaluronate and triamcinolone, and cortisone alone. It will involve 84 patients with moderate to severe shoulder osteoarthritis, who will be randomly assigned to receive one of the two treatments. The study will assess pain relief and functional ability through clinical examinations and patient questionnaires. The goal is to determine if Cingal provides greater pain relief than cortisone in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* A clinical examination that confirms the radiological diagnosis of moderate to severe primary shoulder osteoarthritis, stage II and above, according to the Samilson-Prieto classification.
* Patients aged between 20 and 90 years.
* 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.
* The patient must have the cognitive ability to read and fill out the questionnaires.
* The patient must be able to read and understand French or English

Exclusion Criteria:

* Presence of a transfixing rotator cuff tear assessed on MRI.
* No previous shoulder reconstruction surgery.
* Pregnant woman.
* A patient who has received a cortisone infiltration within 6 months prior to the start of the study.
* A patient who has received a platelet-rich plasma or a hyaluronic acid infiltration within 12 months prior to the start of the study.
* Diagnosis of avascular necrosis.
* Disease affecting the studied joint (systemic inflammatory disease, history of septic arthritis, osteonecrosis, etc.)
* Suspicion or presence of active local infectious process.
* Presence or suspicion of neoplasia or local metastasis.
* Severe trauma to the shoulder ( ≤ 3 months)
* Significant cognitive impairment or insufficient language proficiency to adequately answer the questionnaires.
* Any other serious medical condition that does not allow participation in the study or may be a contraindication to cortisone injection.

Where it's running

• Centre Hospitalier de l'Université de Montréal (CHUM)
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Patrice Tétreault, MD FRCSC — Chum
• Study coordinator: Fidaa Al-Shakfa, M.Sc, MBA
• Email: f.alshakfa.crchum@gmail.com
• Phone: 5148908000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.