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

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Non-surgical and surgical treatments for rotator cuff disease: a pragmatic randomised clinical trial with 2-year follow-up after initial rehabilitation
  1. Sanna Cederqvist1,
  2. Tapio Flinkkilä2,
  3. Markus Sormaala3,
  4. Jari Ylinen4,
  5. Hannu Kautiainen5,6,
  6. Tero Irmola1,
  7. Heidi Lehtokangas1,7,
  8. Juho Liukkonen8,
  9. Konsta Pamilo9,
  10. Tero Ridanpää9,
  11. Kai Sirniö2,
  12. Juhana Leppilahti2,
  13. Ilkka Kiviranta10,11,
  14. Juha Paloneva9,12
  1. 1 Department of Orthopaedics and Traumatology, Tampere University Hospital, Tampere, Finland
  2. 2 Department of Surgery, Division of Orthopaedic and Trauma Surgery, Medical Research Center, Oulu University Hospital, Oulu, Finland
  3. 3 Department of Radiology, Helsinki University Hospital, Helsinki, Finland
  4. 4 Department of Physical Medicine and Rehabilitation, Central Finland Central Hospital, Jyväskylä, Finland
  5. 5 Research Center, Folkhälsan, Helsinki, Finland
  6. 6 Primary Health Care Unit, Kuopio University Hospital, Kuopio, Finland
  7. 7 Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland
  8. 8 Department of Emergency Medicine, Central Finland Central Hospital, Jyväskylä, Finland
  9. 9 Department of Surgery, Central Finland Central Hospital, Jyväskylä, Finland
  10. 10 Department of Orthopaedics and Traumatology, Helsinki University Hospital, Helsinki, Finland
  11. 11 Department of Orthopaedics and Traumatology, University of Helsinki, Helsinki, Finland
  12. 12 Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland
  1. Correspondence to Dr Sanna Cederqvist, Department of Orthopaedics and Traumatology, Tampere University Hospital, Tampere, Finland; sanna.cederqvist{at}icloud.com

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.

  • rehabilitation
  • tendinopathy
  • orthopedic procedures
  • patient reported outcome measures

Data availability statement

Data sharing not applicable as no data sets generated and/or analysed for this study. Study data cannot be shared publicly because of confidentiality requirements under Finnish law. De-identified patient data is available from the study group and from Central Finland Hospital (contact via www.ksshp.fi, juha.paloneva@ksshp.fi) for researchers who meet the criteria for access to confidential data.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

http://dx.doi.org/10.1136/annrheumdis-2020-219099

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    Data availability statement

    Data sharing not applicable as no data sets generated and/or analysed for this study. Study data cannot be shared publicly because of confidentiality requirements under Finnish law. De-identified patient data is available from the study group and from Central Finland Hospital (contact via www.ksshp.fi, juha.paloneva@ksshp.fi) for researchers who meet the criteria for access to confidential data.

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    Footnotes

    • Handling editor Josef S Smolen

    • Correction notice This article has been corrected since it published Online First. The first supplemental file has been replaced.

    • Contributors Concept and design: JP, IK, HK and JY. Acquisition analysis or data interpretation: SC, TF, MS, JY, HK, IK, JP, TI, HL, JLe, JLi, KP, TR and KS. SC and JP had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drafting the manuscript: SC, TF, MS, JY, HK, IK and JP. Critical revision of the manuscript for important intellectual content: SC, TF, MS, JY, HK, IK, JP, TI, HL, JLe, JLi, KP, TR and KS. Statistical analysis: HK, SC and JP. Funding procurement: JP, IK and JLe. Administrative, technical or material support: Study physiotherapists: Saara-Maija Hinkkanen and Nina Sevander-Kreus. Supervision: JP, IK and HK.

    • Funding This work was supported by grants from the Academy of Finland (grant 12321/13.9.2007) 265646/17.4.2013) and National Competitive Research Funding of the University of Eastern Finland. None of the writers have any conflicts of interest relevant to this article.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.