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Randomized Controlled Trial
. 2021 Jun;80(6):796-802.
doi: 10.1136/annrheumdis-2020-219099. Epub 2020 Dec 3.

Non-surgical and surgical treatments for rotator cuff disease: a pragmatic randomised clinical trial with 2-year follow-up after initial rehabilitation

Sanna Cederqvist  1 , Tapio Flinkkilä  2 , Markus Sormaala  3 , Jari Ylinen  4 , Hannu Kautiainen  5   6 , Tero Irmola  7 , Heidi Lehtokangas  7   8 , Juho Liukkonen  9 , Konsta Pamilo  10 , Tero Ridanpää  10 , Kai Sirniö  2 , Juhana Leppilahti  2 , Ilkka Kiviranta  11   12 , Juha Paloneva  10   13
Affiliations
Randomized Controlled Trial

Non-surgical and surgical treatments for rotator cuff disease: a pragmatic randomised clinical trial with 2-year follow-up after initial rehabilitation

Sanna Cederqvist et al. Ann Rheum Dis. 2021 Jun.

Abstract

Background: Rotator cuff disease (RCD) causes prolonged shoulder pain and disability in adults. RCD is a continuum ranging from tendinopathy to full-thickness tendon tear. Recent studies have shown that subacromial decompression and non-surgical treatments provide equivalent results in RCD without a full-thickness tendon lesion. However, the importance of surgery for full-thickness tendon tears remains unclear.

Methods: In a pragmatic, randomised, controlled trial, 417 patients with subacromial pain underwent 3-month initial rehabilitation and MRI arthrography (MRA) for the diagnosis of RCD. Of these, 190 shoulders remained symptomatic and were randomised to non-surgical or surgical treatments. The primary outcomes were the mean changes in the Visual Analogue Scale for pain and the Constant Murley Score for shoulder function at the 2-year follow-up.

Results: At the 2-year follow-up, both non-surgical and surgical treatments for RCD reduced pain and improved shoulder function. The scores differed between groups by 4 (95% CI -3 to 10, p=0.25) for pain and 3.4 (95% CI -0.4 to 7.1, p=0.077) for function. Among patients with full-thickness ruptures, the reduction in pain (13, 95% CI 5 to 22, p=0.002) and improvement in function (7.0, 95% CI 1.8 to 12.2, p=0.008) favoured surgery.

Conclusions: Non-surgical and surgical treatments for RCD provided equivalent improvements in pain and function. Therefore, we recommend non-surgical treatment as the primary choice for patients with RCD. However, surgery yielded superior improvement in pain and function for full-thickness rotator cuff rupture. Therefore, rotator cuff repair may be suggested after failed non-surgical treatment.

Trial registration details: ClinicalTrials.gov, NCT00695981 and NCT00637013.

Keywords: orthopedic procedures; patient reported outcome measures; rehabilitation; tendinopathy.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Trial flow chart. MRA of the shoulder. aMRA. bLack of co-operation or change of diagnosis. mo, months; MRA, MRI arthrography; y, years.
Figure 2
Figure 2
Cumulative frequency of shoulders receiving surgery in surgical and non-surgical randomisation groups with 95% CIs.
Figure 3
Figure 3
Graphs showing the change in pain in the visual analogue scale (VAS, mm) and the Constant score between baseline and the 2-year follow-up in all patients with rotator cuff disease and without and with full-thickness rotator cuff rupture.
See this image and copyright information in PMC

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