RCT between subacromial decompression versus diagnostic arthroscopy for shoulder impingement

30-10-2018
The management of shoulder pain is estimated at 4.5 million visits to doctors and a financial burden of € 2.6 billion each year in the US alone. Since 44-70% of patients with shoulder pain are diagnosed with shoulder impingement syndrome, the annual direct medical costs of this complaint are estimated at more than $ 1bn in the US. The pathognomonic clinical sign of shoulder impingement syndrome, subacromial shoulder pain during lifting of the arm, is often attributed to "impingement" of the tendons of the rotator cuff between the humerus head and the overlying acromion.

Subacromial decompression is one of the most commonly performed orthopedic procedures in the world despite the fact that different non-surgical treatment modalities are recommended as initial treatment for patients with shoulder impact symptoms. Between the 1980s and 2010, the number of subacromial decompression procedures increased many times with the advent of arthroscopy.

A multicentre, randomized, double-blind, placebo-surgically controlled study by Paavola et al (BMJ 2018) was performed at the orthopedic department in three public hospitals in Finland. Participants consist of 210 patients with symptoms consistent with shoulder impingement syndrome, enrolled from 1 February, 2005 with a follow-up of two years completed before June 25, 2015. The aim of the study is to assess the efficacy of arthroscopic subacromial decompression (ASD) in patients with shoulder complaints consistent with shoulder impingement syndrome by comparing it with diagnostic arthroscopy, a placebo surgical intervention and with a non-surgical alternative, exercise therapy, in a more pragmatic setting.

With the primary intent to treat the analysis (ASD versus diagnostic arthroscopy), there was no clinically relevant difference between the group differences in the two primary outcomes (mean change for ASD 36.0 at rest and 55.4 for activity at 24 months) for diagnostic arthroscopy 31.4 at rest and 47.5 for activity). The observed mean difference between the groups (ASD minus diagnostic arthroscopy) in pain VAS was -4.6 (95% confidence interval -11.3 to 2.1) points (P = 0.18) at rest and -9.0 (-18.1 to 0.2) points (P = 0.054)) on arm activity. No differences were observed between the ASD and diagnostic arthroscopy groups in the secondary outcomes or adverse reactions. In the secondary equation (ASD versus exercise therapy), statistically significant differences were found after 24 months in both VAS at rest (-7.5, -14.0 to -1.0, points, P = 0.023) in favor of ASD in the two primary outcomes and VAS on arm activity (-12.0, -20.9 to -3.2, points, P = 0.008). The mean differences between groups do not exceed the pre-specified minimum clinically important difference.

The results of this randomized, placebo-surgically controlled study show that arthroscopic subacromial decompression after 24 months does not offer a clinically relevant advantage over diagnostic arthroscopy in patients with shoulder impingement syndrome.

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