Recruiting

Shoulder Infiltrations

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT05408065

Conditions

Infiltration

Shoulder Osteoarthritis

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

Interventions

Triamcinolone Hexacetonide and hyaluronic acid

Triamcinolone Hexacetonide

Study Details

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

Conditions

Infiltration

Shoulder Osteoarthritis

Study ID

NCT05408065

Start date

Nov 15, 2022

Status verified date

Feb, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Cingal

A single infiltration of Cingal, 4 mL, 88 of mg hyaluronic acid and 18 mg of triamcinolone hexacetonide

active comparator: Cortisone

A single infiltration of cortisone, 40mg of triamcinolone and 4mL of bupivacaine 0.25%

Interventions

Triamcinolone Hexacetonide and hyaluronic acid

infiltration under fluoroscopy

Triamcinolone Hexacetonide

infiltration under fluoroscopy

Primary outcome measure

  • Change in VAS score [ Time Frame: Change from baseline (preinfiltration visit) VAS score at 3 months after the infiltration ]

Central Contacts and Locations

Central contacts

Fidaa Al-Shakfa, M.Sc, MBA

5148908000f.alshakfa.crchum@gmail.com

Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Contacts

Fidaa Al-Shakfa, M.Sc

5148908000f.alshakfa.crchum@gmail.com

Principal Investigator:

Patrice Tétreault, MD FRCSC

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Feb 12, 2024

Last verified

Feb, 2024

Keywords

  • infiltration
  • Osteoarthritis
  • hyaluronic acid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2024-02-12.