Comparison of the Analgesic Effect of 2 Shoulder Infiltrations

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.

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

Study Overview

• Status: Recruiting
• Conditions: Shoulder Osteoarthritis; Infiltration
• Intervention / Treatment: Drug: Triamcinolone Hexacetonide and hyaluronic acid; Drug: Triamcinolone Hexacetonide

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fidaa Al-Shakfa, M.Sc, MBA; Phone Number: 26103 5148908000; Email: f.alshakfa.crchum@gmail.com

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 0C1
      • Recruiting
      • Centre Hospitalier de l'Universite de Montreal (CHUM)
      • Contact: Fidaa Al-Shakfa, M.Sc; Phone Number: 26103 5148908000; Email: f.alshakfa.crchum@gmail.com
      • Principal Investigator: Patrice Tétreault, MD FRCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cingal; A single infiltration of Cingal, 4 mL, 88 of mg hyaluronic acid and 18 mg of triamcinolone hexacetonide	Drug: Triamcinolone Hexacetonide and hyaluronic acid; infiltration under fluoroscopy; Other Names: Cingal
Active Comparator: Cortisone; A single infiltration of cortisone, 40mg of triamcinolone and 4mL of bupivacaine 0.25%	Drug: Triamcinolone Hexacetonide; infiltration under fluoroscopy; Other Names: Cortisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 1 month after the infiltration
Change in VAS score	Visual analogue score VAS; 0-10 scale, 0: no pain 10: worst pain	Change from baseline (preinfiltration visit) VAS score at 6 months after the infiltration
Change in QuickDash disability/symptoms score	QuickDash; 0-100 scale, 0: no difficulties 100: unable	Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration
Change in QuickDash disability/symptoms score	QuickDash; 0-100 scale, 0: no difficulties 100: unable	Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration
Change QuickDash disability/symptoms score	QuickDash; 0-100 scale, 0: no difficulties 100: unable	Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration
Change in QuickDash Work score	QuickDash; 0-100 scale, 0: no difficulties 100: unable	Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration
Change in QuickDash Work score	QuickDash; 0-100 scale, 0: no difficulties 100: unable	Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration
Change in QuickDash Work score	QuickDash; 0-100 scale, 0: no difficulties 100: unable	Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration
Change in QuickDash Sport/Music score	QuickDash; 0-100 scale, 0: no difficulties 100: unable	Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration
Change in QuickDash Sport/Music score	QuickDash; 0-100 scale, 0: no difficulties 100: unable	Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration
Change in QuickDash Sport/Music score	QuickDash; 0-100 scale, 0: no difficulties 100: unable	Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Patrice Tétreault, MD FRCSC, CHUM

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Osteoarthritis; hyaluronic acid; infiltration
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Hyaluronic Acid; Cortisone
• Other Study ID Numbers: 2023-10659

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No