Clinical trial NCT05408065: Comparison of the Analgesic Effect of 2 Shoulder Infiltrations
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infiltration
Shoulder Osteoarthritis
Keywords: infiltration
Osteoarthritis
hyaluronic acid
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: Change in VAS score
timeFrame: Change from baseline (preinfiltration visit) VAS score at 3 months after the infiltration
Secondary outcomes:
measure: Change in VAS score
timeFrame: Change from baseline (preinfiltration visit) VAS score at 1 month after the infiltration
measure: Change in VAS score
timeFrame: Change from baseline (preinfiltration visit) VAS score at 6 months after the infiltration
measure: Change in QuickDash disability/symptoms score
timeFrame: Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration
measure: Change in QuickDash disability/symptoms score
timeFrame: Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration
measure: Change QuickDash disability/symptoms score
timeFrame: Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration
measure: Change in QuickDash Work score
timeFrame: Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration
measure: Change in QuickDash Work score
timeFrame: Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration
measure: Change in QuickDash Work score
timeFrame: Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration
measure: Change in QuickDash Sport/Music score
timeFrame: Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration
measure: Change in QuickDash Sport/Music score
timeFrame: Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration
measure: Change in QuickDash Sport/Music score
timeFrame: Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: CHUM
name: Patrice Tétreault, MD FRCSC
role: PRINCIPAL_INVESTIGATOR
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