Department of Orthopaedics, Leiden University Medical Center, Leiden, the Netherlands.
Department of Radiology, Leiden University Medical Center, Leiden, the Netherlands.
Am J Sports Med. 2017 Dec;45(14):3305-3314. doi: 10.1177/0363546517721686. Epub 2017 Sep 12.
Barbotage (needling and lavage) is often applied in the treatment of calcific tendinitis of the rotator cuff (RCCT). In a previously published randomized controlled trial, we reported superior clinical and radiological 1-year outcomes for barbotage combined with a corticosteroid injection in the subacromial bursa (SAIC) compared with an isolated SAIC. There are no trials with a midterm or long-term follow-up of barbotage available.
To compare the 5-year results of 2 regularly applied treatments of RCCT: ultrasound (US)-guided barbotage combined with a SAIC (group 1) versus an isolated US-guided SAIC (group 2).
Randomized controlled trial; Level of evidence, 1.
Patients were randomly assigned to group 1 or 2 and evaluated before and after treatment at regular time points until 12 months and also at 5 years using the Constant score (CS), the Western Ontario Rotator Cuff Index (WORC), and the Disabilities of the Arm, Shoulder and Hand (DASH). The calcification location and size and Gärtner classification were assessed on radiographs. The rotator cuff condition was evaluated with US. Results were analyzed using t tests, linear regression, and a mixed model for repeated measures.
Forty-eight patients were included (mean age, 52.0 ± 7.3 years; 25 [52%] female) with a mean baseline CS of 68.7 ± 11.9. After a mean follow-up of 5.1 ± 0.5 years, the mean CS was 90 (95% CI, 83.0-95.9) in group 1 versus 87 (95% CI, 80.5-93.5) in group 2 ( P = .58). The mean improvement in the CS in group 1 was 18 (95% CI, 12.3-23.0) versus 21 (95% CI, 16.2-26.2) in group 2 ( P = .32). There was total resorption in 62% of group 1 and 73% of group 2 ( P = .45). The US evaluation of the rotator cuff condition showed no significant differences between the groups. With the mixed model for repeated measures, taking into account the baseline CS and Gärtner classification, the mean treatment effect for barbotage was 6 (95% CI, -8.9 to 21.5), but without statistical significance. Follow-up scores were significantly associated with baseline scores and the duration of follow-up. Results for the DASH and WORC were similar. There were no significant complications, but 4 patients in group 1 and 16 in group 2 underwent additional treatment during the follow-up period ( P < .001).
No more significant differences were found in the clinical and radiological outcomes between barbotage combined with a SAIC versus an isolated SAIC after 5 years of follow-up. Registration: NTR2282 (Dutch Trial Registry).
滑囊冲洗术（针刺和灌洗）常用于治疗肩袖钙化性肌腱炎（RCCT）。在之前发表的一项随机对照试验中，我们报告了滑囊冲洗术联合肩峰下囊（SAIC）皮质类固醇注射的临床和影像学 1 年结果优于单纯 SAIC。目前尚无中期或长期随访滑囊冲洗术的试验。
比较 2 种常规治疗 RCCT 的 5 年结果：超声（US）引导下滑囊冲洗术联合 SAIC（组 1）与单纯 US 引导下 SAIC（组 2）。
随机对照试验；证据水平，1 级。
患者随机分配至组 1 或组 2，并在治疗前和治疗后定期进行评估，直至 12 个月，并在 5 年时使用常数评分（CS）、Western Ontario Rotator Cuff Index（WORC）和 Disabilities of the Arm, Shoulder and Hand（DASH）进行评估。在 X 线片上评估钙化位置和大小及 Gärtner 分级。使用 US 评估肩袖状况。使用 t 检验、线性回归和重复测量混合模型分析结果。
共纳入 48 例患者（平均年龄 52.0±7.3 岁；25 [52%] 为女性），基线 CS 平均为 68.7±11.9。平均随访 5.1±0.5 年后，组 1 的 CS 平均为 90（95%CI，83.0-95.9），组 2 为 87（95%CI，80.5-93.5）（P=.58）。组 1 的 CS 平均改善 18（95%CI，12.3-23.0），组 2 为 21（95%CI，16.2-26.2）（P=.32）。组 1 中 62%的患者和组 2 中 73%的患者完全吸收（P=.45）。两组间 US 评估肩袖状况无显著差异。采用重复测量混合模型，考虑基线 CS 和 Gärtner 分级，滑囊冲洗术的平均治疗效果为 6（95%CI，-8.9 至 21.5），但无统计学意义。随访评分与基线评分和随访时间显著相关。DASH 和 WORC 评分结果相似。无明显并发症，但组 1 中有 4 例患者和组 2 中有 16 例患者在随访期间接受了额外治疗（P<0.001）。
5 年随访后，滑囊冲洗术联合 SAIC 与单纯 SAIC 相比，在临床和影像学结果方面未发现显著差异。
NTR2282（荷兰试验注册处）。
