AB1409 EFFICACY AND SAFETY OF SODIUM THIOSULFATE IN CALCIFIC TENDINITIS OF THE ROTATOR CUFF – ANALYSIS OF AN ONGOING RANDOMIZED CLINICAL TRIAL

• Published in: Annals of the rheumatic diseases Vol. 82; no. Suppl 1; pp. 1933 - 1934
• Main Authors: Parente, H, Azevedo, S, Guimarães, F, C Dantas Soares, M Pontes Ferreira, Faria, D, Peixoto, D, Tavares-Costa, J, Afonso, C, Teixeira, F
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group LTD 01.06.2023
• Subjects: Arm; Calcification; Clinical trials; Comorbidity; Elbow; Lavage; Pain; Patients; Range of motion; Rotator cuff; Shoulder; Sodium thiosulfate; Statistical analysis; Tendinitis; Ultrasonic imaging; Ultrasound
• ISSN: 0003-4967; 1468-2060
• DOI: 10.1136/annrheumdis-2023-eular.5156

BackgroundCalcific tendinitis of the rotator cuff is a major cause of omalgia. [1] Ultrasound guided percutaneous lavage (UGPL) is indicated when conservative treatments fail. [2] Recent reports interested the use of topical sodium thiosulfate (STS) in the treatment of other diseases with ectopic calcifications [3, 4, 5].ObjectivesTo assess the efficacy and safety of UGPL with STS versus with saline solution (standard of care - SOC) in calcific tendinitis.MethodsDouble-blinded randomized clinical trial including adult patients with calcific tendinitis, omalgia ≥3 months and ≥1 positive shoulder impingement test. Only dense type A calcifications (Molé Classification) >5 mm in diameter were included. Patients were randomized in two groups: STS and SOC lavage. Informed consents were collected. Both groups were reevaluated at week 1, month 1 and 3 after UGPL. Pain Visual Analogue Scale (VAS) at rest and during activities, shoulder range of motion and strength, impingement tests, Disabilities of the Arm, Shoulder and Hand (DASH), DASH-Work, EuroQol five-dimensional (EQ5D) and University of California at Los Angeles (UCLA) scores, ultrasound (US) and radiographic evaluations were performed on all follow up visits.SPSS was used for statistical analysis with a significance level of 2-sided p<0.05.ResultsWe included 32 patients, where 78.1% (25) were women, with a mean age of 51.0 (SD=8.5) years old. Pain’s mean duration before the procedure was 16.3 months (SD=22.3).We randomized 18 patients (56.3%) to the control group (SOC) and performed a saline UGPL; the other 14 patients (43.8%) to the treatment group (STS). Baseline characteristics are shown in table 1. Since patient inclusion is dynamic, our sample met 28 patients at week 1 (SOC=15 and STS=13), 26 patients at month 1 (SOC=14 and STS=12) and 21 patients at month 3 (SOC=10 and STS=11).Both procedures numerically improved pain, range of motion, functionality and calcification size, but only SOC lavage was statistically significant for calcification size reduction (p=0.005), EQ5D, DASH work and UCLA improvements (p=0.021, 0.042 and 0.03, respectively), while both STS and SOC lavage statistically reduced the DASH score (p=0.014 and 0.06, respectively).No adverse effects/complications were reported.ConclusionAlthough well tolerated with no side effects, STS UGPL has failed to uphold the SOC benefits for calcific tendinopathy. Further studies using STS are needed to ascertain its interest in this disease. This on-going work will be reevaluated with a larger sample.Table 1.Demographic and baseline clinical characteristics.STS lavage (n=14)Saline solution lavage (n=18)p-valueAge (years), mean (SD)52.1 (9.7)50.1 (7.6)NSSex, female % (n/N)78.6% (11/14)77.8% (14/18)NSNumber of comorbidities, median (IQR)1 (2)0 (1)NSDominant side, right % (n/N)92.9% (13/14)94.4% (17/18)NSNocturnal pain, yes % (n/N)100% (14/14)100% (18/18)NSPain duration, median (IQR)18 (31)6 (8)0.022Shoulder range of motion, median (IQR)165 (90)180 (90)NSVAS at rest (0–10), mean (SD)5.6 (1.8)5.8 (2.1)NSVAS during activities (0–10), mean (SD)7.1 (1.6)6.1 (2.2)NSDASH Score, mean (SD)56.4 (14.1)53.5 (14.8)NSDASH-Work Score, mean (SD)70.7 (10.4)65.1 (20.8)NSEQ5D, mean (SD)0.36 (0.33)0.41 (0.20)NSVAS EQ5D (0–100), mean (SD)56.4 (15.6)60.3 (21.3)NSUCLA score, mean (SD)17.7 (4.7)14.7 (3.2)0.041Bursitis, yes % (n/N)57.1% (8/14)61.1% (11/18)NSCalcification morphology, % (n/N) Acr-shaped Fragmented Nodular and dense, weel-defined21.4% (3/14) 21.4% (3/14) 57.1% (8/14)44.4% (8/18) 27.8% (5/18) 27.8% (5/18)NSCalcification size, median (IQR)12.6 (3.6)12.5 (6.3)NSSD: Standard deviation; M: Mean; NS: non-significant; IQR: interquartile rangeReferences[1]Louwerens JK et al. J Shoulder Elbow Surg. 2015; 24:1588–93.[2]De Witte PB et al. Am J Sports Med. 2013; 41:1665-73.[3]Ossorio-García L et al. Actas Dermosifiliogr. 2016; 107:359-62. 21.[4]Jost J et al. J Clin Endocrinol Metab. 2016; 101:2810-5. 22.[5]Guigonis V et al. Ann Endocrinol (Paris). 2015; 76:183-4.Acknowledgements:NIL.Disclosure of InterestsNone Declared.