Arthroscopic subacromial decompression versus placebo surgery for subacromial pain syndrome: 10 year follow-up of the FIMPACT randomised, placebo surgery controlled trial.

Methods

Randomised, placebo surgery controlled trial.

随机安慰手术对照试验。

Orthopaedic department of three public hospitals in Finland.

芬兰三家公立医院的骨科部门。

210 adults aged 35 to 65 years with symptoms consistent with subacromial pain syndrome for more than three months, enrolled from 1 February 2005 with 10 year follow-up to 20 September 2023.

210名年龄在35至65岁之间的成年人，其症状与肩峰下疼痛综合征一致，持续时间超过三个月，从2005年2月1日起开始招募，随访时间长达10年，直至2023年9月20日。

Participants and outcome assessors were blinded to group allocation in the primary (ASD versus placebo surgery) comparison.

在主要比较（ASD与安慰剂手术）中，参与者和结果评估者对组别分配不知情。

ASD, placebo surgery, and exercise therapy (1:1:1).

ASD、安慰剂手术和运动疗法（1:1:1）。

Exercise therapy was used as a pragmatic comparator.

运动疗法被用作实用的对照比较。

The primary outcomes were shoulder pain at rest and on arm activity, both assessed at 10 years using a visual analogue scale (VAS, ranging from 0 to 100, with 0 denoting no pain).

主要结果是静息时和手臂活动时的肩部疼痛，两者均在10年时使用视觉模拟量表（VAS，范围从0到100，0表示无疼痛）进行评估。

The minimally important difference was defined as 15.

最小重要差异被定义为15。

A mixed model repeated measures analysis of variance was used, treating participants as random factors, incorporating baseline values as covariates.

使用了混合模型重复测量方差分析，将参与者作为随机因素，并将基线值作为协变量。

Results

Participants were randomly assigned to ASD (n=59), placebo surgery (n=63), and exercise therapy (n=71).

参与者被随机分配到ASD组(n=59)，安慰剂手术组(n=63)和运动疗法组(n=71)。

Of these, a total of 168 participants (87%) completed the 10 year follow-up.

在这些参与者中，共有168名（87%）完成了10年的随访。

In the primary intention-to-treatanalysis (ASD versus placebo surgery), no between group differences were observed for the two primary outcomes at 10 years: the mean difference between groups (ASD minus placebo surgery) was -1.5 points (95% confidence interval(CI) -8.6 to 5.6) in VAS pain score at rest and -3.2 points (-13.0 to 6.5) in VAS pain score on arm activity.

在主要的意向治疗分析（ASD与安慰剂手术对比）中，10年时两个主要结果指标未见组间差异：两组间平均差异（ASD减去安慰剂手术）在静息时的VAS疼痛评分上为-1.5分（95%置信区间（CI）-8.6至5.6），在手臂活动时的VAS疼痛评分上为-3.2分（95%置信区间-13.0至6.5）。

No significant between group differences were found for any of the secondary outcomes or adverse events.

对于任何次要结果指标或不良事件，未发现组间有显著差异。

In the pragmatic comparison, the mean difference between groups (ASD minus exercise therapy) was -4.0 points (-11.0 to 3.0) in VAS pain score at rest and -9.4 points (-19.0 to 0.3) in VAS pain score on arm activity.

在实用性比较中，两组间平均差异（ASD减去运动疗法）在静息状态下的VAS疼痛评分中为-4.0分（-11.0至3.0），在手臂活动的VAS疼痛评分中为-9.4分（-19.0至0.3）。

No significant between group differences were observed for the secondary outcomes or adverse events.

对于次要结果或不良事件，未观察到两组之间有显著差异。

Conclusions

In patients with subacromial pain syndrome, ASD offered no benefit over placebo surgery or exercise therapy during 10 year follow-up.

在患有肩峰下疼痛综合征的患者中，与安慰剂手术或运动疗法相比，ASD在10年的随访期间没有显示出任何益处。

trial_registration

ClinicalTrials.gov NCT00428870.

ClinicalTrials.gov NCT00428870。