近日，芬兰赫尔辛基大学教授Mika Paavola及其研究小组开发出关节镜肩峰下减压与安慰剂手术治疗肩峰下疼痛综合征：FIMPACT随机、安慰剂手术对照试验的10年随访。这一研究成果于2025年12月2日发表在国际顶尖学术期刊《英国医学杂志》上。

目的：评估关节镜下肩峰下减压（ASD）与安慰剂手术（诊断性关节镜）和运动治疗对肩峰下疼痛综合征患者的长期疗效。

设计：随机、安慰剂手术对照试验。

设置：芬兰三家公立医院的骨科。

参与者：从2005年2月1日至2023年9月20日，210名年龄在35至65岁之间，症状符合肩峰下疼痛综合征超过3个月的成年人入组，随访10年。参与者:结果评估者对初始组（ASD与安慰剂手术）的分组进行盲法比较。干预措施ASD、安慰剂手术和运动疗法（1:1:1）。运动疗法被用作实用比较。

主要结果：测量主要结果是休息时的肩痛和手臂活动时的肩痛，两者都是在10年内使用视觉模拟量表（VAS，范围从0到100,0表示无疼痛）进行评估。最小重要差异定义为15。采用混合模型重复测量方差分析，处理参与者:作为随机因素，结合基线值作为协变量。

参与者：随机分为ASD组（n=59）、安慰剂组（n=63）和运动组（n=71）。其中，共有168个参与者:（87%）完成了10年随访。在主要意向治疗分析（ASD与安慰剂手术）中，在10年的两个主要结局中，两组之间没有观察到差异：各组（ASD减去安慰剂手术）休息时VAS疼痛评分的平均差异为1.5分（95%置信区间（CI） 8.6至5.6），手臂活动时VAS疼痛评分的平均差异为3.2分（13.0至6.5）。在次要结局或不良事件方面，两组间无显著差异。在语用性比较中，两组（ASD减去运动治疗）休息时VAS疼痛评分的平均差异为- 4.0分（- 11.0 ~ 3.0），手臂活动时VAS疼痛评分的平均差异为- 9.4分（- 19.0 ~ 0.3）。在次要结局或不良事件方面，组间无显著差异。

结论：在10年的随访中，对于肩峰下疼痛综合征患者，ASD没有比安慰剂手术或运动治疗更好的疗效。

附：英文原文

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

Author: Kari Kanto, Mathias Bck, Thomas Ibounig, Robert Bjrkenheim, Antti Malmivaara, Tomasz Czuba, Jari Inkinen, Juha Kalske, Vesa Savolainen, Ilkka Sinisaari, Pirjo Toivonen, Simo Taimela, Teppo L N Jrvinen, Mika Paavola

Issue&Volume: 2025/12/02

Abstract: Objective To assess the long term efficacy of arthroscopic subacromial decompression (ASD) versus placebo surgery (diagnostic arthroscopy) and exercise therapy in patients with subacromial pain syndrome.

Design Randomised, placebo surgery controlled trial.

Setting Orthopaedic department of three public hospitals in Finland.

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

Interventions ASD, placebo surgery, and exercise therapy (1:1:1). Exercise therapy was used as a pragmatic comparator.

Main outcome measures 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). The minimally important difference was defined as 15. A mixed model repeated measures analysis of variance was used, treating participants as random factors, incorporating baseline values as covariates.

Results Participants were randomly assigned to ASD (n=59), placebo surgery (n=63), and exercise therapy (n=71). Of these, a total of 168 participants (87%) completed the 10 year follow-up. In the primary intention-to-treat analysis (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. No significant between group differences were found for any of the secondary outcomes or adverse events. 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. No significant between group differences were observed for the secondary outcomes or adverse events.

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

DOI: 10.1136/bmj-2025-086201

Source: https://www.bmj.com/content/391/bmj-2025-086201