Department of Rheumatology, CHU Nantes, Nantes, France.
Department of Rheumatology, CHD Vendée, La Roche sur Yon, France.
Ann Rheum Dis. 2019 Jun;78(6):837-843. doi: 10.1136/annrheumdis-2018-214971. Epub 2019 Apr 11.
Steroid injections are common after an ultrasound-guided puncture and lavage (UGPL) of calcific tendonitis of the rotator cuff. However, steroids may prevent calcification resorption and negatively affect tendon healing. Our study was designed to determine whether saline solution was non-inferior to steroids in the prevention of acute pain reactions in the week following UGPL.
This was a randomised, double-blinded, controlled non-inferiority trial with 12-month follow-up. We included 132 patients (66 in each group) with symptomatic calcification measuring more than 5 mm. Patients received 1 mL of saline or steroid (methylprednisolone 40 mg) in the subacromial bursa at the end of UGPL. Primary outcome was the maximal pain during the week following the procedure with a prespecified non-inferiority margin of 10 mm (0-100 visual analogue scale). Secondary outcomes included pain at rest and during activity, function (disabilities of the arm, shoulder and hand score) and radiological evolution of the calcification over the 12-month follow-up.
The estimated mean difference in the first week's maximal pain between these two groups was 11.76 (95% CI 3.78 to 19.75). Steroids significantly improved VAS pain at rest and during activities, as well as function at 7 days and 6 weeks. They did not change the rate of calcification resorption, which occurred in 83% and 74% of patients at 12 months in the saline and steroid groups.
Non-inferiority of saline when compared with steroids could not be established. However, steroid injection improved pain in the 6 weeks following the procedure, and function in the 3 months after, with no significant effect on calcification resorption.
NTC02403856.
在超声引导下肩袖钙化性肌腱炎穿刺灌洗（UGPL）后，常进行类固醇注射。然而，类固醇可能会阻止钙化吸收并对肌腱愈合产生负面影响。我们的研究旨在确定在 UGPL 后一周内，生理盐水是否在预防急性疼痛反应方面不劣于类固醇。
这是一项随机、双盲、对照的非劣效性试验，随访时间为 12 个月。我们纳入了 132 名（每组 66 名）症状性钙化超过 5 毫米的患者。在 UGPL 结束时，患者在肩峰下囊内接受 1 毫升生理盐水或类固醇（甲泼尼龙 40 毫克）。主要结局是术后一周内的最大疼痛，规定非劣效性边界为 10 毫米（0-100 视觉模拟评分）。次要结局包括休息和活动时的疼痛、功能（手臂、肩和手功能障碍评分）以及 12 个月随访期间钙化的影像学演变。
这两组在第一周的最大疼痛估计平均差异为 11.76（95%CI 3.78 至 19.75）。类固醇显著改善了休息和活动时的 VAS 疼痛以及 7 天和 6 周时的功能。它们并没有改变钙化吸收的速度，在 12 个月时，生理盐水组和类固醇组分别有 83%和 74%的患者发生钙化吸收。
生理盐水与类固醇相比，不能确定其非劣效性。然而，类固醇注射可改善术后 6 周内的疼痛，并在术后 3 个月内改善功能，对钙化吸收无显著影响。
NTC02403856。
