Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0C1, Canada
Location status: Recruiting
Location contact
Fidaa Al-Shakfa, M.Sc
CONTACT
5148908000 ext. 26103
Patrice Tétreault, MD FRCSC
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05408065
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
Interested in participating?
Request Info20 year and older
All sexes
Interventional
Not applicable
Montreal, Quebec, H2X 0C1, Canada
Location status: Recruiting
Fidaa Al-Shakfa, M.Sc
CONTACT
5148908000 ext. 26103
Patrice Tétreault, MD FRCSC
PRINCIPAL_INVESTIGATOR
Osteoarthritis is a degenerative joint disease. The progressive erosion of cartilage generates inflammation, pain, and progressive deterioration of joint mobility. Synthetic molecules similar to hyaluronic acid have made it possible to offer patients the option of visco-supplementation by intra-articular injection. It decreases inflammation and pain. CINGAL (Anika Therapeutics, Inc., Bedford, MA), which combines the lubricating action of hyaluronic acid and the anti-inflammatory action of triamcinolone hexacetonide, is one of the available treatments. Several studies have demonstrated the effectiveness of hyaluronic acid in the relief of gonarthrosis. However, the efficacy between an infiltration of hyaluronic acid combined with triamcinolone and a corticosteroid infiltration for glenohumeral osteoarthritis is hardly reviewed in scientific studies.
Primary objective: To compare the analgesic effect of two different infiltrations.
Secondary outcome: To evaluate the patient's functional ability
It is anticipated that a CINGAL infiltration will have a greater beneficial effect than a simple cortisone infiltration in patients with mild to severe shoulder OA.
84 patients with moderate to severe shoulder osteoarthritis will be recruited to receive intra-articular infiltration of CINGAL or cortisone. The infiltration will be randomly assigned. A standard x-ray and magnetic resonance imaging examination will be performed before the infiltration. Demographic data, medical history and 2 questionnaires will be completed prior to infiltration.
Once the evaluation is completed, the patient is randomized and referred to radiology to receive his infiltration under fluoroscopy by a radiologist assigned to the project. Two electronic questionnaires and a medication diary will be sent to the patient at 1, 3 and 6 months post-infiltration.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
infiltration under fluoroscopy
Other names: Cingal
infiltration under fluoroscopy
Other names: Cortisone
Time frame: Change from baseline (preinfiltration visit) VAS score at 3 months after the infiltration
Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst possible pain
Time frame: Change from baseline (preinfiltration visit) VAS score at 1 month after the infiltration
Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst possible pain
Time frame: Change from baseline (preinfiltration visit) VAS score at 6 months after the infiltration
Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst pain
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Time frame: Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Contact information is provided by the study sponsor or research team.
Centre hospitalier de l'Université de Montréal (CHUM)
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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