Comparison of the Analgesic Effect of 2 Shoulder Infiltrations

NCT05408065 | Recruiting DMC

• 1 other identifier: 2023-10659
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Keywords

infiltration; Osteoarthritis; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Change in VAS score

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

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

Secondary Outcomes (11)

• Change in VAS score

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

• Change in VAS score

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

• Change in QuickDash disability/symptoms score

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

• Change in QuickDash disability/symptoms score

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

• Change QuickDash disability/symptoms score

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

Study Arms (2)

Cingal

EXPERIMENTAL

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

Drug: Triamcinolone Hexacetonide and hyaluronic acid

Cortisone

ACTIVE COMPARATOR

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

Drug: Triamcinolone Hexacetonide

Interventions

Triamcinolone Hexacetonide and hyaluronic acid DRUG

infiltration under fluoroscopy

Also known as: Cingal

Cingal

Triamcinolone Hexacetonide DRUG

infiltration under fluoroscopy

Also known as: Cortisone

Cortisone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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.
• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

Related Publications (11)

• Brox JI, Lereim P, Merckoll E, Finnanger AM. Radiographic classification of glenohumeral arthrosis. Acta Orthop Scand. 2003 Apr;74(2):186-9. doi: 10.1080/00016470310013932.

  PMID: 12807327 BACKGROUND

• Hangody L, Szody R, Lukasik P, Zgadzaj W, Lenart E, Dokoupilova E, Bichovsk D, Berta A, Vasarhelyi G, Ficzere A, Hangody G, Stevens G, Szendroi M. Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial. Cartilage. 2018 Jul;9(3):276-283. doi: 10.1177/1947603517703732. Epub 2017 May 23.

  PMID: 28535076 BACKGROUND

• Noel E, Hardy P, Hagena FW, Laprelle E, Goebel F, Faure C, Favard L, Gaudin P, Christ R, Baudot C, Dietl J, Goupille P. Efficacy and safety of Hylan G-F 20 in shoulder osteoarthritis with an intact rotator cuff. Open-label prospective multicenter study. Joint Bone Spine. 2009 Dec;76(6):670-3. doi: 10.1016/j.jbspin.2009.10.008.

  PMID: 19945321 BACKGROUND

• He WW, Kuang MJ, Zhao J, Sun L, Lu B, Wang Y, Ma JX, Ma XL. Efficacy and safety of intraarticular hyaluronic acid and corticosteroid for knee osteoarthritis: A meta-analysis. Int J Surg. 2017 Mar;39:95-103. doi: 10.1016/j.ijsu.2017.01.087. Epub 2017 Jan 27.

  PMID: 28137554 BACKGROUND

• Petrella RJ, Petrella M. A prospective, randomized, double-blind, placebo controlled study to evaluate the efficacy of intraarticular hyaluronic acid for osteoarthritis of the knee. J Rheumatol. 2006 May;33(5):951-6.

  PMID: 16652426 BACKGROUND

• Petrella RJ, Emans PJ, Alleyne J, Dellaert F, Gill DP, Maroney M. Safety and performance of Hydros and Hydros-TA for knee osteoarthritis: a prospective, multicenter, randomized, double-blind feasibility trial. BMC Musculoskelet Disord. 2015 Mar 18;16:57. doi: 10.1186/s12891-015-0513-6.

  PMID: 25887932 BACKGROUND

• Smith C, Patel R, Vannabouathong C, Sales B, Rabinovich A, McCormack R, Belzile EL, Bhandari M. Combined intra-articular injection of corticosteroid and hyaluronic acid reduces pain compared to hyaluronic acid alone in the treatment of knee osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2019 Jun;27(6):1974-1983. doi: 10.1007/s00167-018-5071-7. Epub 2018 Jul 25.

  PMID: 30046992 BACKGROUND

• Samilson RL, Prieto V. Dislocation arthropathy of the shoulder. J Bone Joint Surg Am. 1983 Apr;65(4):456-60.

  PMID: 6833319 BACKGROUND

• Tammachote N, Kanitnate S, Yakumpor T, Panichkul P. Intra-Articular, Single-Shot Hylan G-F 20 Hyaluronic Acid Injection Compared with Corticosteroid in Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial. J Bone Joint Surg Am. 2016 Jun 1;98(11):885-92. doi: 10.2106/JBJS.15.00544.

  PMID: 27252432 BACKGROUND

• Walch G, Badet R, Boulahia A, Khoury A. Morphologic study of the glenoid in primary glenohumeral osteoarthritis. J Arthroplasty. 1999 Sep;14(6):756-60. doi: 10.1016/s0883-5403(99)90232-2.

  PMID: 10512449 BACKGROUND

• Zhang B, Thayaparan A, Horner N, Bedi A, Alolabi B, Khan M. Outcomes of hyaluronic acid injections for glenohumeral osteoarthritis: a systematic review and meta-analysis. J Shoulder Elbow Surg. 2019 Mar;28(3):596-606. doi: 10.1016/j.jse.2018.09.011. Epub 2018 Nov 28.

  PMID: 30502030 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

triamcinolone hexacetonide; Hyaluronic Acid; Cortisone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Patrice Tétreault, MD FRCSC

  CHUM

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fidaa Al-Shakfa, M.Sc, MBA

CONTACT

5148908000; f.alshakfa.crchum@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: June 7, 2022
• Study Start: November 15, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)