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超声引导下皮质类固醇注射与安慰剂联合运动疗法治疗跟腱病的随机临床试验。

Effect of Ultrasonography-Guided Corticosteroid Injection vs Placebo Added to Exercise Therapy for Achilles Tendinopathy: A Randomized Clinical Trial.

机构信息

Institute of Sports Medicine, Department of Orthopedic Surgery M, Bispebjerg Hospital, Copenhagen, Denmark.

Center for General Practice at Aalborg University, Aalborg University, Aalborg, Denmark.

出版信息

JAMA Netw Open. 2022 Jul 1;5(7):e2219661. doi: 10.1001/jamanetworkopen.2022.19661.

Abstract

IMPORTANCE

Corticosteroid injections and exercise therapy are commonly used to treat chronic midportion Achilles tendinopathy, but the evidence for this combination is limited.

OBJECTIVE

To investigate the effect of corticosteroid injection and exercise therapy compared with placebo injection and exercise therapy for patients with Achilles tendinopathy.

DESIGN, SETTING, AND PARTICIPANTS: This was a participant-blinded, physician-blinded, and assessor-blinded randomized clinical trial of patients with Achilles tendinopathy verified by ultrasonography. Assessment of pain and function were conducted at baseline and at 1, 2, 3, 6, 12, and 24 months. Patients were recruited from a university medical clinic and a private rheumatology clinic in Denmark between April 2016 and September 2018. Data analysis was performed from June to September 2021.

INTERVENTIONS

Corticosteroid injection and placebo injection were performed with ultrasonography guidance. Exercise therapy was based on previous trials and consisted of 3 exercises done every second day.

MAIN OUTCOMES AND MEASURES

The primary outcome was the Victorian Institute of Sports Assessment-Achilles (VISA-A) score (range, 1-100, with 100 representing no symptoms) at 6 months. Secondary outcomes included pain measured using a 100-mm Visual Analog Scale for morning pain and pain during exercise (with higher scores indicating worse pain), global assessment (Likert scale), and tendon thickness.

RESULTS

A total of 100 patients were included, with 52 randomized to placebo (mean age, 46 years [95% CI, 44-48 years]; 32 men [62%]) and 48 randomized to corticosteroid injection (mean age, 47 years [95% CI, 45-49 years]; 28 men [58%]). Patients in the 2 groups had similar height (mean [SD], 177 [8] cm), weight (mean [SD], 79 [12] kg), and VISA-A score (mean [SD], 46 [18]) at baseline. The group receiving exercise therapy combined with corticosteroid injections had a 17.7-point (95% CI, 8.4-27.0 points; P < .001) larger improvement in VISA-A score compared with patients receiving exercise therapy combined with placebo injections at 6 months. No severe adverse events were observed in either group, and there was no deterioration in the long term (2-year follow-up).

CONCLUSIONS AND RELEVANCE

Corticosteroid injections combined with exercise therapy were associated with better outcomes in the treatment of Achilles tendinopathy compared with placebo injections and exercise therapy. A combination of exercise therapy and corticosteroid injection should be considered in the management of long-standing Achilles tendinopathy.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02580630.

摘要

重要性

皮质类固醇注射和运动疗法常用于治疗慢性中段跟腱病,但这种联合治疗的证据有限。

目的

研究皮质类固醇注射和运动疗法与安慰剂注射和运动疗法治疗跟腱病患者的效果。

设计、地点和参与者:这是一项参与者盲法、医生盲法和评估者盲法的随机临床试验,研究对象为经超声检查证实的跟腱病患者。在基线、1、2、3、6、12 和 24 个月时进行疼痛和功能评估。患者于 2016 年 4 月至 2018 年 9 月在丹麦的一所大学诊所和一家私人风湿病诊所招募。数据分析于 2021 年 6 月至 9 月进行。

干预措施

皮质类固醇注射和安慰剂注射均在超声引导下进行。运动疗法基于以往的试验,包括每天进行 3 次的 3 项运动。

主要结局和测量指标

主要结局是 6 个月时的维多利亚运动评估-跟腱(VISA-A)评分(范围 1-100,100 表示无症状)。次要结局包括使用 100 毫米视觉模拟量表评估早晨疼痛和运动时疼痛(得分越高表示疼痛越严重)、总体评估(Likert 量表)和跟腱厚度。

结果

共有 100 名患者入选,其中 52 名患者随机分配至安慰剂组(平均年龄 46 岁[95%置信区间 44-48 岁];32 名男性[62%]),48 名患者随机分配至皮质类固醇注射组(平均年龄 47 岁[95%置信区间 45-49 岁];28 名男性[58%])。两组患者的身高(平均[标准差],177[8]cm)、体重(平均[标准差],79[12]kg)和 VISA-A 评分(平均[标准差],46[18])在基线时相似。接受皮质类固醇注射联合运动疗法的患者在 6 个月时 VISA-A 评分的改善幅度比接受安慰剂注射联合运动疗法的患者大 17.7 分(95%置信区间,8.4-27.0 分;P < .001)。两组均未观察到严重不良事件,且长期(2 年随访)无恶化。

结论和相关性

与安慰剂注射和运动疗法相比,皮质类固醇注射联合运动疗法在治疗跟腱病方面的效果更好。在治疗慢性跟腱病时,应考虑将运动疗法与皮质类固醇注射相结合。

试验注册

ClinicalTrials.gov 标识符:NCT02580630。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fb1a/9274322/d6bc8a6c3831/jamanetwopen-e2219661-g001.jpg

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