Effects of adjuvant application of corticosteroid and ozone after ultrasound-guided puncture and lavage for the treatment of rotator cuff calcifific tendinitis: study protocol for a non-inferiority randomized controlled trial

Abstract

Abstract Background: Steroid injection after percutaneous irrigation of calcific deposits is a common method for treatment of rotator cuff calcifific tendinitis(RCCT). However, steroid may prevent calcification resorption and cause potential irreversible damage to tendons. Recent studies have confirmed the positive effects of ozone injection in shoulder tendinopathies,but the application in RCCT has not been reported.Thus, our study aims to evaluate the non-inferiority of ozone versus steroid injection. Methods: This is a prospective, randomized, parallel control and non-inferiority trial. A total of 100 patients with unilateral symptomatic RCCT will be enrolled and randomised in a 1:1 ratio to two groups: ultrasound-guided injection with ozone or corticosteroid.The primary outcome is the numeric rating scale for pain(NRS) at 1 week and 3 months following the procedure. Secondary outcomes include multi- dimensional evaluation of shoulder disability and quality of life improvement,degree of calcification absorption after treatment and the number of multiple treatments. Discussion: The results of this study will provide short-term and long-term evidence for ozone treatment of RCCT in relieving pain or improving shoulder function. Trial registration: Chinese Clinical Trial Registry ChiCTR2200063469.Registered on 7 September 2022.