NCT05408065 Comparison of the Analgesic Effect of 2 Shoulder Infiltrations
| NCT ID | NCT05408065 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Infiltration |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2022-11-15 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2022-11-15 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
For patients suffering of osteoarthritis, only analgesic treatments such as anti-inflammatory drugs and cortisone infiltrations provide significant but temporary relief of their pain. The objective is to compare the analgesic effect of 2 infiltrations: Cingal (sodium hyaluronate and triamcinolone) versus cortisone (triamcinolone). It is anticipated that the Cingal infiltration will have a greater analgesic effect than a simple cortisone infiltration in patients with moderate to severe osteoarthritis of the shoulder. Method: * Randomized controlled trial * Monocentric * Randomization will be done using sealed envelopes
Eligibility 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.
Contact & Investigator
Patrice Tétreault, MD FRCSC
PRINCIPAL INVESTIGATOR
CHUM
Frequently Asked Questions
Who can join the NCT05408065 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Infiltration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05408065 currently recruiting?
Yes, NCT05408065 is actively recruiting participants. Contact the research team at f.alshakfa.crchum@gmail.com for enrollment information.
Where is the NCT05408065 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05408065 clinical trial?
NCT05408065 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The principal investigator is Patrice Tétreault, MD FRCSC at CHUM. The trial plans to enroll 84 participants.