Ultrasound guided lavage with corticosteroid injection versus sham lavage with and without corticosteroid injection for calcific tendinopathy of shoulder: randomised double blinded multi-arm study

Abstract

Objective: To compare treatment effects between ultrasound guided lavage with corticosteroid injection and sham lavage with and without corticosteroid injection in patients with calcific tendinopathy of the shoulder.

Design: Pragmatic, three arm, parallel group, double blinded, sham controlled, randomised, superiority trial with repeated measurements over 24 months.

Setting: Six hospitals in Norway and Sweden.

Participants: 220 adults with calcific tendinopathy of the shoulder, persistent for at least three months.

Interventions: Ultrasound guided deposit lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (lavage+steroid); sham lavage plus subacromial injection of 20 mg triamcinolone acetonide and 9 mL 1% lidocaine hydrochloride (sham lavage+steroid); or sham lavage plus subacromial injection of 10 mL 1% lidocaine hydrochloride (sham). All patients received a physiotherapeutic treatment regimen consisting of four home exercises.

Main outcome measures: The primary outcome was the result on the 48 point scale (0=worst; 48=best) of the Oxford Shoulder Score (OSS) at four month follow-up. Secondary outcomes included measurements on the short form of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) and of pain intensity up to 24 months. The influence of the size of the deposit at baseline and of the persistence or disappearance of the deposit was investigated.

Results: Data from 218 (99%) participants were included in the primary analysis. Differences between groups on the OSS at four months were not significant: lavage+steroid versus sham 0.2 (95% confidence interval -2.3 to 2.8; P=1.0); sham lavage+steroid versus sham 2.0 (-0.5 to 4.6; P=0.35); lavage+steroid versus sham lavage+steroid -1.8 (-4.3 to 0.7; P=0.47). After four months, 143 patients with insufficient treatment effect received supplementary treatment. At 24 months, none of the study procedures was superior to sham. No serious adverse events were reported.

Conclusions: This study found no benefit for ultrasound guided lavage with a corticosteroid injection or for sham lavage with a corticosteroid injection compared with sham treatment in patients with calcific rotator cuff tendinopathy of the shoulder.

Trial registration: NCT02419040EudraCT 2015-002343-34; Ethical committee Norway 2015-002343-34; Ethical committee Sweden 2015/79-31; Clinicaltrials.gov NCT02419040.

Fig 1

Trial flowchart. Screening, randomisation, and primary outcome population. ESWT=extracorporal shock wave therapy; ITT=intention to treat. *Protocol violations related to treatment (supplementary treatment was given) were noted before the 4 month follow-up for 14 participants (4 for lavage+steroid, 3 for sham lavage+steroid, 7 for sham) and after the 4 month follow-up for 129 patients (42 for lavage+steroid, 50 for sham lavage+steroid, and 37 for sham)

Fig 2

Results by treatment group. Whiskers represent 95% confidence intervals. X axes are not proportionally displayed. (A) Oxford Shoulder Score (OSS). Y axis shows interval only from 20 to 40 points. Higher score indicates better shoulder function. (B) Shortened version of Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH). Y axis shows interval only from 0 to 50 points. Lower score indicates better upper extremity function. (C) Visual analogue scale (VAS) for pain at night by treatment group. Y axis shows interval only from 0 to 80 mm. Lower result indicates less pain. (D) VAS for pain at rest. Y axis shows interval only from 0 to 80 mm. Lower result indicates less pain. (E) VAS for pain at activity. Y axis shows interval only from 20 to 80 mm. Lower result indicates less pain. (F) EQ-5D-5L general health score. Y axis shows only interval from 0.50 to 1.0 index points. Higher index value indicates better health related quality of life