Comparison of the Analgesic Effect of 2 Shoulder Infiltrations
Recruiting · NCT05408065 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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 is running
1 location listed.
- Centre Hospitalier de l'Université de Montréal (CHUM) - Montreal, Quebec, Canada