The efficacy of intra-articular triamcinolone acetonide 10 mg vs. 40 mg in patients with knee osteoarthritis: a non-inferiority, randomized, controlled, double-blind, multicenter study

Komchan Utamawatin, Ong-Art Phruetthiphat, Rit Apinyankul, Sumapa Chaiamnuay, Komchan Utamawatin, Ong-Art Phruetthiphat, Rit Apinyankul, Sumapa Chaiamnuay

Abstract

Background: Intra-articular (IA) corticosteroid injection is recommended in refractory knee osteoarthritis patients. However, 40-mg of triamcinolone IA every 3 months for 2 years reduces cartilage volume as compared to saline IA.

Objective: To determine the non-inferiority of 10-mg versus 40-mg of triamcinolone acetonide (TA) for treatment of pain in symptomatic knee osteoarthritis at week 12.

Methods: This was a double-blind, randomized, controlled trial conducted in 84 symptomatic knee osteoarthritis patients. The 10-mg or 40-mg of TA were 1:1 randomized and injected to the affected knees. The primary outcome was the 12-week difference from baseline in pain VAS, with a pre-specified lower margin for non-inferiority of 10 mm. The measuring instruments used were: Visual analog scale (VAS: 0-10), modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), EuroQol Group 5 Dimensions (EQ5D), Knee Injuries and Osteoarthritis Outcome Score (KOOS) questionnaire, chair standing test and 20-m walking time at baseline, at week 4, and week 12 after randomization. Adverse events were recorded.

Results: Baseline characteristics were similar between two groups. The mean differences of pain VAS (95% confidence interval: CI) between the two groups at baseline and week 12 were 0.8 (-0.8, 2.4) with p of 0.002 for non-inferiority. There were no differences in pain reduction and quality of life improvement between 10-mg and 40-mg groups. The mean differences (95%CI) of WOMAC, KOOS pain, EQ5D and KOOS quality of life between baseline and week 12 were 0.4 (-1.1, 1.9). -8.7 (-21.3, 3.9), 1.3(-7.1, 9.6) and 1.8 (-11.5, 15.0), respectively. There were significant improvements in pain and quality of life between baseline and week 12 in both groups.

Conclusion: The 10 mg of TA is non-inferior to 40 mg TA in improving pain in patients with symptomatic knee OA. Both 10 mg and 40 mg of TA significantly improved pain and quality of life in patients with symptomatic knee OA.

Trial registration: TCTR, I TCTR20210224002. Retrospectively registered 24 February 2021, http://www.thaiclinicaltrials.org/show/TCTR20210224002.

Keywords: Intra-articular corticosteriod injection; Knee; Non-inferiority trial; Osteoarthritis; Triamcinolone acetonide.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2023. The Author(s).

Figures

Fig. 1
Fig. 1
Flowchart of patients with symptomatic knee osteoarthritis throughout the study
Fig. 2
Fig. 2
Non-inferiority of intraarticular Triamcinolone 10 mg versus Triamcinolone 40 mg for the treatment of symptomatic knee osteoarthritis
Fig. 3
Fig. 3
Treatment effects of triamcinolone acetonide 10 and 40 mg on secondary efficacy outcomes including WOMAC pain subscale (a), WOMAC stiffness subscale (b), EQ5D assessment (c) and global visual analog scale assessment (d)

References

    1. Long H, Liu Q, Yin H, Wang K, Diao N, Zhang Y, et al. Prevalence trends of site-specific osteoarthritis from 1990 to 2019: findings from the global burden of disease study 2019. Arthritis Rheumatol. 2022;74(7):1172–1183. doi: 10.1002/art.42089.
    1. Bruyere O, Honvo G, Veronese N, Arden NK, Branco J, Curtis EM, et al. An updated algorithm recommendation for the management of knee osteoarthritis from the European society for clinical and economic aspects of osteoporosis, osteoarthritis and musculoskeletal diseases (ESCEO) Semin Arthritis Rheum. 2019;49(3):337–350. doi: 10.1016/j.semarthrit.2019.04.008.
    1. Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, et al. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019;27(11):1578–1589. doi: 10.1016/j.joca.2019.06.011.
    1. Lomonte AB, de Morais MG, de Carvalho LO, Zerbini CA. Efficacy of triamcinolone hexacetonide versus methylprednisolone acetate intraarticular injections in knee osteoarthritis: a randomized, double-blinded, 24-week Study. J Rheumatol. 2015;42(9):1677–1684. doi: 10.3899/jrheum.150297.
    1. Juni P, Hari R, Rutjes AW, Silletta MG, Reichenbach S, et al. Intra-articular corticosteroid for knee osteoarthritis. Cochrane Database Syst Rev. 2015;2015(10):CD005328..
    1. Wernecke C, Braun HJ, Dragoo JL. The effect of intra-articular corticosteroids on articular cartilage: a systematic review. Orthop J Sports Med. 2015;3(5):2325967115581163. doi: 10.1177/2325967115581163.
    1. Kolasinski SL, Neogi T, Hochberg MC, Oatis C, Guyatt G, Block J, et al. 2019 American college of rheumatology/arthritis foundation guideline for the management of osteoarthritis of the hand, hip, and knee. Arthritis Rheumatol. 2020;72(2):220–233. doi: 10.1002/art.41142.
    1. van Doormaal MCM, Meerhoff GA, Vliet Vlieland TPM, Peter WF. A clinical practice guideline for physical therapy in patients with hip or knee osteoarthritis. Musculoskeletal Care. 2020;18(4):575–595. doi: 10.1002/msc.1492.
    1. McAlindon TE, LaValley MP, Harvey WF, Price LL, Driban JB, Zhang M, et al. Effect of intra-articular triamcinolone vs saline on knee cartilage volume and pain in patients with knee osteoarthritis: a randomized clinical trial. JAMA. 2017;317(19):1967–1975. doi: 10.1001/jama.2017.5283.
    1. Yavuz U, Sokucu S, Albayrak A, Ozturk K. Efficacy comparisons of the intraarticular steroidal agents in the patients with knee osteoarthritis. Rheumatol Int. 2012;32(11):3391–3396. doi: 10.1007/s00296-011-2188-0.
    1. Deyle GD, Allen CS, Allison SC, Gill NW, Hando BR, Petersen EJ, et al. Physical therapy versus glucocorticoid injection for osteoarthritis of the knee. N Engl J Med. 2020;382(15):1420–1429. doi: 10.1056/NEJMoa1905877.
    1. Beyaz SG. Comparison of efficacy of intra-articular morphine and steroid in patients with knee osteoarthritis. J Anaesthesiol Clin Pharmacol. 2012;28(4):496–500. doi: 10.4103/0970-9185.101940.
    1. Chao J, Wu C, Sun B, Hose MK, Quan A, Hughes TH, et al. Inflammatory characteristics on ultrasound predict poorer longterm response to intraarticular corticosteroid injections in knee osteoarthritis. J Rheumatol. 2010;37(3):650–655. doi: 10.3899/jrheum.090575.
    1. Kohn MD, Sassoon AA, Fernando ND. Classifications in brief: Kellgren-Lawrence classification of osteoarthritis. Clin Orthop Relat Res. 2016;474(8):1886–1893. doi: 10.1007/s11999-016-4732-4.
    1. Kuptniratsaikul V, Rattanachaiyanont M. Validation of a modified Thai version of the Western Ontario and McMaster (WOMAC) osteoarthritis index for knee osteoarthritis. Clin Rheumatol. 2007;26(10):1641–1645. doi: 10.1007/s10067-007-0560-y.
    1. Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee injury and osteoarthritis outcome score (KOOS)–development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998;28(2):88–96. doi: 10.2519/jospt.1998.28.2.88.
    1. Chaipinyo K. Test-retest reliability and construct validity of the Thai version of knee osteoarthritis outcome scores (KOOS) Thai J Physical Therapy. 2009;31(2):67–76.
    1. Pattanaphesaj J, Thavorncharoensap M, Ramos-Goni JM, Tongsiri S, Ingsrisawang L, Teerawattananon Y. The EQ-5D-5L valuation study in Thailand. Expert Rev Pharmacoecon Outcomes Res. 2018;18(5):551–558. doi: 10.1080/14737167.2018.1494574.
    1. Ehrich EW, Davies GM, Watson DJ, Bolognese JA, Seidenberg BC, Bellamy N. Minimal perceptible clinical improvement with the Western Ontario and McMaster universities osteoarthritis index questionnaire and global assessments in patients with osteoarthritis. J Rheumatol. 2000;27(11):2635–2641.
    1. Arroll B, Goodyear-Smith F. Corticosteroid injections for osteoarthritis of the knee: meta-analysis. BMJ. 2004;328(7444):869. doi: 10.1136/bmj.38039.573970.7C.
    1. Popma JW, Snel FW, Haagsma CJ, Brummelhuis-Visser P, Oldenhof HG, van der Palen J, et al. Comparison of 2 dosages of intraarticular triamcinolone for the treatment of knee arthritis: results of a 12-week randomized controlled clinical trial. J Rheumatol. 2015;42(10):1865–1868. doi: 10.3899/jrheum.141630.
    1. Gaffney K, Ledingham J, Perry JD. Intra-articular triamcinolone hexacetonide in knee osteoarthritis: factors influencing the clinical response. Ann Rheum Dis. 1995;54(5):379–381. doi: 10.1136/ard.54.5.379.
    1. Friedman DM, Moore ME. The efficacy of intraarticular steroids in osteoarthritis: a double-blind study. J Rheumatol. 1980;7(6):850–856.
    1. van Vliet-Daskalopoulou E, Jentjens T, Scheffer RT. Intra-articular rimexolone in the rheumatoid knee: a placebo-controlled, double-blind, multicentre trial of three doses. Br J Rheumatol. 1987;26(6):450–453. doi: 10.1093/rheumatology/26.6.450.
    1. Lazaro D, Alon L, Ramessar N, Cabas-Vargas J, Shwin K, Stefanov DG. Intra-articular, bursa, and tendon sheath injections: a survey of practice patterns among members of the American college of rheumatology. J Clin Rheumatol. 2014;20(2):91–93. doi: 10.1097/RHU.0000000000000080.

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する