Comparison of the Analgesic Effect of 2 Shoulder Infiltrations

Recruiting now · Not applicable

Conditions studied: Infiltration, Shoulder Osteoarthritis

In brief

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

Key facts

Study ID

NCT05408065

Run by

Centre hospitalier de l'Université de Montréal (CHUM)

People needed

84

Starts

2022-11-15

Expected to finish

2026-12-01

Last updated by the study team

2024-02-12

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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