Comparison of the Analgesic Effect of 2 Shoulder Infiltrations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Triamcinolone Hexacetonide and hyaluronic acid
Druginfiltration under fluoroscopy
Triamcinolone Hexacetonide
Druginfiltration under fluoroscopy
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: CingalExperimental treatment 1 intervention
Group B: CortisoneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in VAS score
Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst possible pain
Time frame
Change from baseline (preinfiltration visit) VAS score at 3 months after the infiltrationSecondary outcomes
1
Change in VAS score
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 infiltration2
Change in VAS score
Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst pain
Time frame
Change from baseline (preinfiltration visit) VAS score at 6 months after the infiltration3
Change in QuickDash disability/symptoms score
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Time frame
Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration4
Change in QuickDash disability/symptoms score
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Time frame
Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltrationSponsors and contacts
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Source ClinicalTrials.gov