Comparison of the Analgesic Effect of 2 Shoulder Infiltrations
Study Details
Study Description
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:
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Randomized controlled trial
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Monocentric
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Randomization will be done using sealed envelopes
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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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:
|
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:
|
Outcome Measures
Primary Outcome Measures
- Change in VAS score [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 Outcome Measures
- Change in VAS score [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
- Change in VAS score [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
- Change in QuickDash disability/symptoms score [Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration]
QuickDash; 0-100 scale, 0: no difficulties 100: unable
- Change in QuickDash disability/symptoms score [Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration]
QuickDash; 0-100 scale, 0: no difficulties 100: unable
- Change QuickDash disability/symptoms score [Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration]
QuickDash; 0-100 scale, 0: no difficulties 100: unable
- Change in QuickDash Work score [Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration]
QuickDash; 0-100 scale, 0: no difficulties 100: unable
- Change in QuickDash Work score [Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration]
QuickDash; 0-100 scale, 0: no difficulties 100: unable
- Change in QuickDash Work score [Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration]
QuickDash; 0-100 scale, 0: no difficulties 100: unable
- Change in QuickDash Sport/Music score [Change from baseline (preinfiltration visit) QuickDash score at 1 month after the infiltration]
QuickDash; 0-100 scale, 0: no difficulties 100: unable
- Change in QuickDash Sport/Music score [Change from baseline (preinfiltration visit) QuickDash score at 3 months after the infiltration]
QuickDash; 0-100 scale, 0: no difficulties 100: unable
- Change in QuickDash Sport/Music score [Change from baseline (preinfiltration visit) QuickDash score at 6 months after the infiltration]
QuickDash; 0-100 scale, 0: no difficulties 100: unable
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Patients aged between 20 and 90 years.
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A patient with bilateral shoulder osteoarthritis will choose the side of the infiltration, only one side can be chosen to participate in the study.
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The patient must have a clinical pain threshold of a minimum of 4/10 on the visual analogue scale.
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The patient must have the cognitive ability to read and fill out the questionnaires.
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The patient must be able to read and understand French or English
Exclusion Criteria:
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Presence of a transfixing rotator cuff tear assessed on MRI.
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No previous shoulder reconstruction surgery.
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Pregnant woman.
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A patient who has received a cortisone infiltration within 6 months prior to the start of the study.
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A patient who has received a platelet-rich plasma or a hyaluronic acid infiltration within 12 months prior to the start of the study.
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Diagnosis of avascular necrosis.
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Disease affecting the studied joint (systemic inflammatory disease, history of septic arthritis, osteonecrosis, etc.)
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Suspicion or presence of active local infectious process.
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Presence or suspicion of neoplasia or local metastasis.
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Severe trauma to the shoulder ( ≤ 3 months)
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Significant cognitive impairment or insufficient language proficiency to adequately answer the questionnaires.
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Any other serious medical condition that does not allow participation in the study or may be a contraindication to cortisone injection.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Centre Hospitalier de l'Université de Montréal (CHUM) | Montreal | Quebec | Canada | H2X 0C1 |
Sponsors and Collaborators
- Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
- Principal Investigator: Patrice Tétreault, MD FRCSC, CHUM
Study Documents (Full-Text)
None provided.More Information
Publications
- Brox JI, Lereim P, Merckoll E, Finnanger AM. Radiographic classification of glenohumeral arthrosis. Acta Orthop Scand. 2003 Apr;74(2):186-9.
- Hangody L, Szody R, Lukasik P, Zgadzaj W, Lénárt 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.
- 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. Review.
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- 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.
- 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.
- Samilson RL, Prieto V. Dislocation arthropathy of the shoulder. J Bone Joint Surg Am. 1983 Apr;65(4):456-60.
- 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. Review.
- 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.
- 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.
- 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.
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