Comparing two types of shoulder injections for osteoarthritis pain relief
A Randomized Single-blinded Clinical Trial of the Efficacy of Intra-articular Infiltration of Cingal (Sodium Hyaluronate/Triamcinolone) Versus Cortisone (Triamcinolone) in Patients With Osteoarthritis of the Shoulder.
This study is testing whether a new shoulder injection called Cingal can help people with moderate to severe shoulder osteoarthritis feel less pain compared to a standard cortisone injection.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05408065 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 90 with moderate to severe primary shoulder osteoarthritis and a pain level of at least 4/10.
Not a fit: Patients with certain exclusions, such as those with a rotator cuff tear or who have had recent cortisone injections, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective pain management option for patients with shoulder osteoarthritis.
How similar studies have performed: While several studies have shown the effectiveness of hyaluronic acid for other joint conditions, the specific comparison of Cingal and cortisone for shoulder osteoarthritis is less explored, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Montreal, Quebec
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.