Comparison of the Analgesic Effect of 2 Shoulder Infiltrations
Key facts
- Where
- Montreal, CanadaSee the site
Where in Canada
- Centre Hospitalier de l'Universite de Montreal (CHUM)Montreal, CanadaContact: Fidaa Al-Shakfa, M.ScTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Centre hospitalier de l'Université de Montréal (CHUM)
- Trial code
- NCT05408065
- Record updated
- 12 February 2024
- Original description
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.Read full original descriptionShow less
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.
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
Inclusion: 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: No previous shoulder reconstruction surgery; A patient who has received a cortisone infiltration within 6 months prior to the start of the study; Disease affecting the studied joint (systemic inflammatory disease, history of septic arthritis, osteonecrosis, etc.); 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; A patient who has received a platelet-rich plasma or a hyaluronic acid infiltration within 12 months prior to the start of the study; Presence of a transfixing rotator cuff tear assessed on MRI; Pregnant woman; Diagnosis of avascular necrosis; Suspicion or presence of active local infectious process; Presence or suspicion of neoplasia or local metastasis; Severe trauma to the shoulder ( ≤ 3 months).