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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cingal | Experimental | A single infiltration of Cingal, 4 mL, 88 of mg hyaluronic acid and 18 mg of triamcinolone hexacetonide |
|
| Cortisone | Active Comparator | A single infiltration of cortisone, 40mg of triamcinolone and 4mL of bupivacaine 0.25% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone Hexacetonide and hyaluronic acid | Drug | infiltration under fluoroscopy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fidaa Al-Shakfa, M.Sc, MBA | Contact | 5148908000 | 26103 | f.alshakfa.crchum@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Patrice Tétreault, MD FRCSC | CHUM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal (CHUM) | Recruiting | Montreal | Quebec | H2X 0C1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12807327 | Background | 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. | |
| 28535076 | 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. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C005900 | triamcinolone hexacetonide |
| D006820 | Hyaluronic Acid |
| D003348 | Cortisone |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D011283 | Pregnenes |
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| Triamcinolone Hexacetonide | Drug | infiltration under fluoroscopy |
|
|
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 |
| 19945321 | 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. |
| 28137554 | 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. |
| 16652426 | 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. |
| 25887932 | 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. |
| 30046992 | 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. |
| 6833319 | Background | Samilson RL, Prieto V. Dislocation arthropathy of the shoulder. J Bone Joint Surg Am. 1983 Apr;65(4):456-60. |
| 27252432 | 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. |
| 10512449 | 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. |
| 30502030 | 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. |
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015065 | 17-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |