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New treatment option for Infiltration
Official title Comparison of the Analgesic Effect of 2 Shoulder Infiltrations
ClinicalTrials.gov ID: NCT05408065
What this study is testing
What is Triamcinolone Hexacetonide and hyaluronic acid?
Triamcinolone Hexacetonide and hyaluronic acid is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for infiltration.
Also referred to as Cingal.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- A clinical examination that confirms the radiological diagnosis of moderate to severe primary shoulder osteoarthritis, stage II and above, according...
- 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.
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.