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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.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
RECRUITING
Montreal
Contact Information
Primary
Fidaa Al-Shakfa, M.Sc, MBA
f.alshakfa.crchum@gmail.com
5148908000
Time Frame
Start Date: 2022-11-15
Estimated Completion Date: 2026-12
Participants
Target number of participants: 84
Treatments
Experimental: Cingal
A single infiltration of Cingal, 4 mL, 88 of mg hyaluronic acid and 18 mg of triamcinolone hexacetonide
Active_comparator: Cortisone
A single infiltration of cortisone, 40mg of triamcinolone and 4mL of bupivacaine 0.25%
Related Therapeutic Areas
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)

This content was sourced from clinicaltrials.gov