Comparison of the Analgesic Effect of 2 Shoulder Infiltrations

Shoulder Osteoarthritis Clinical Trial

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05408065
• Other study ID #: 2023-10659
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Fidaa Al-Shakfa, M.Sc, MBA
• Phone: 5148908000
• Email: f.alshakfa.crchum[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infiltration
• Osteoarthritis
• Shoulder Osteoarthritis

Intervention

Drug:
• Triamcinolone Hexacetonide and hyaluronic acid
infiltration under fluoroscopy
• Triamcinolone Hexacetonide
infiltration under fluoroscopy

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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