Comparison of the Analgesic Effect of 2 Shoulder Infiltrations
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.
Centre hospitalier de l'Université de Montréal (CHUM)
84 participants
Nov 15, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria12
- 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.
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Interventions
infiltration under fluoroscopy
infiltration under fluoroscopy
Locations(1)
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NCT05408065