Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT05408065

Comparison of the Analgesic Effect of 2 Shoulder Infiltrations

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2024-02-12

84

Participants Needed

1

Research Sites

211 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Comparison of the Analgesic Effect of 2 Shoulder Infiltrations

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada, H2X 0C1

Actively Recruiting

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Research Team

F

Fidaa Al-Shakfa, M.Sc, MBA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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