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Clinical Trials in Canada / NCT05408065
Recruiting Not applicable

Comparison of the Analgesic Effect of 2 Shoulder Infiltrations

NCT05408065 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2022-11-15
Last updated
2024-02-12

Condition(s) studied

InfiltrationShoulder Osteoarthritis

Investigational drug(s) / intervention(s)

Triamcinolone Hexacetonide and hyaluronic acidTriamcinolone Hexacetonide →

Triamcinolone Hexacetonide and hyaluronic acid: infiltration under fluoroscopy

Triamcinolone Hexacetonide: infiltration under fluoroscopy

Study 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

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier de l'Université de Montréal (CHUM) Montreal Quebec Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05408065 on ClinicalTrials.gov ↗ ← All trials in Canada