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NCT Number: NCT05408065

Comparison of the Analgesic Effect of 2 Shoulder Infiltrations

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

Recruiting

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0C1, Canada

Location status: Recruiting

Location contact

Fidaa Al-Shakfa, M.Sc

CONTACT

[email protected]

5148908000 ext. 26103

Patrice Tétreault, MD FRCSC

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triamcinolone Hexacetonide and hyaluronic acid

Drug

infiltration under fluoroscopy

Other names: Cingal

Triamcinolone hexacetonide

Drug

infiltration under fluoroscopy

Other names: Cortisone

Primary outcomes

  1. Change in VAS score

    Time frame: Change from baseline (preinfiltration visit) VAS score at 3 months after the infiltration

    Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst possible pain

Secondary outcomes

  1. Change in VAS score

    Time frame: Change from baseline (preinfiltration visit) VAS score at 1 month after the infiltration

    Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst possible pain

  2. Change in VAS score

    Time frame: Change from baseline (preinfiltration visit) VAS score at 6 months after the infiltration

    Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst pain

  3. Change in QuickDash disability/symptoms score

    Time frame: Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration

    QuickDash; 0-100 scale, 0: no difficulties 100: unable

  4. Change in QuickDash disability/symptoms score

    Time frame: Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration

    QuickDash; 0-100 scale, 0: no difficulties 100: unable

  5. Change QuickDash disability/symptoms score

    Time frame: Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration

    QuickDash; 0-100 scale, 0: no difficulties 100: unable

  6. Change in QuickDash Work score

    Time frame: Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration

    QuickDash; 0-100 scale, 0: no difficulties 100: unable

  7. Change in QuickDash Work score

    Time frame: Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration

    QuickDash; 0-100 scale, 0: no difficulties 100: unable

  8. Change in QuickDash Work score

    Time frame: Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration

    QuickDash; 0-100 scale, 0: no difficulties 100: unable

  9. Change in QuickDash Sport/Music score

    Time frame: Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration

    QuickDash; 0-100 scale, 0: no difficulties 100: unable

  10. Change in QuickDash Sport/Music score

    Time frame: Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration

    QuickDash; 0-100 scale, 0: no difficulties 100: unable

  11. Change in QuickDash Sport/Music score

    Time frame: Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration

    QuickDash; 0-100 scale, 0: no difficulties 100: unable

Study contacts

Contact information is provided by the study sponsor or research team.

Fidaa Al-Shakfa, M.Sc, MBA

CONTACT

[email protected]

5148908000 ext. 26103

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 7, 2022
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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