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

BackgroundRotator 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 f...

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Published in:	Annals of the rheumatic diseases Vol. 80; no. 6; pp. 796 - 802
Main Authors:	Cederqvist, Sanna, Flinkkilä, Tapio, Sormaala, Markus, Ylinen, Jari, Kautiainen, Hannu, Irmola, Tero, Lehtokangas, Heidi, Liukkonen, Juho, Pamilo, Konsta, Ridanpää, Tero, Sirniö, Kai, Leppilahti, Juhana, Kiviranta, Ilkka, Paloneva, Juha
Format:	Journal Article
Language:	English
Published:	England BMJ Publishing Group Ltd and European League Against Rheumatism 01.06.2021 Elsevier Limited BMJ Publishing Group
Subjects:	Adult Arthritis Arthroscopy - methods Decompression Follow-Up Studies Hospitals Humans Informed consent Injuries Magnetic resonance imaging orthopedic procedures Pain patient reported outcome measures Patients Rehabilitation Rotator cuff Rotator Cuff - diagnostic imaging Rotator Cuff - surgery Shoulder Shoulder Pain - etiology Surgery tendinopathy Tendons Treatment Treatment Outcome Finland orthopedic procedures patient reported outcome measures rehabilitation tendinopathy
ISSN:	0003-4967, 1468-2060, 1468-2060
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Abstract	BackgroundRotator 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.MethodsIn 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.ResultsAt 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.ConclusionsNon-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 detailsClinicalTrials.gov, NCT00695981 and NCT00637013.
AbstractList	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. 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. 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. 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. ClinicalTrials.gov, NCT00695981 and NCT00637013. BackgroundRotator 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.MethodsIn 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.ResultsAt 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.ConclusionsNon-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 detailsClinicalTrials.gov, NCT00695981 and NCT00637013. 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.BACKGROUNDRotator 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.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.METHODSIn 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.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.RESULTSAt 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.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.CONCLUSIONSNon-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.ClinicalTrials.gov, NCT00695981 and NCT00637013.TRIAL REGISTRATION DETAILSClinicalTrials.gov, NCT00695981 and NCT00637013.
Author	Sormaala, Markus Kautiainen, Hannu Ylinen, Jari Pamilo, Konsta Lehtokangas, Heidi Flinkkilä, Tapio Irmola, Tero Paloneva, Juha Kiviranta, Ilkka Sirniö, Kai Ridanpää, Tero Liukkonen, Juho Leppilahti, Juhana Cederqvist, Sanna
AuthorAffiliation	9 Department of Surgery , Central Finland Central Hospital , Jyväskylä , Finland 11 Department of Orthopaedics and Traumatology , University of Helsinki , Helsinki , Finland 1 Department of Orthopaedics and Traumatology , Tampere University Hospital , Tampere , Finland 3 Department of Radiology , Helsinki University Hospital , Helsinki , Finland 5 Research Center , Folkhälsan , Helsinki , Finland 6 Primary Health Care Unit , Kuopio University Hospital , Kuopio , Finland 4 Department of Physical Medicine and Rehabilitation , Central Finland Central Hospital , Jyväskylä , Finland 10 Department of Orthopaedics and Traumatology , Helsinki University Hospital , Helsinki , Finland 12 Institute of Clinical Medicine , University of Eastern Finland , Kuopio , Finland 7 Faculty of Medicine and Health Technology , Tampere University , Tampere , Finland 8 Department of Emergency Medicine , Central Finland Central Hospital , Jyväskylä , Finland 2 Department of Surgery, Division of Orthopaedic and Trauma Surge
AuthorAffiliation_xml	– name: 6 Primary Health Care Unit , Kuopio University Hospital , Kuopio , Finland – name: 1 Department of Orthopaedics and Traumatology , Tampere University Hospital , Tampere , Finland – name: 4 Department of Physical Medicine and Rehabilitation , Central Finland Central Hospital , Jyväskylä , Finland – name: 7 Faculty of Medicine and Health Technology , Tampere University , Tampere , Finland – name: 5 Research Center , Folkhälsan , Helsinki , Finland – name: 8 Department of Emergency Medicine , Central Finland Central Hospital , Jyväskylä , Finland – name: 11 Department of Orthopaedics and Traumatology , University of Helsinki , Helsinki , Finland – name: 3 Department of Radiology , Helsinki University Hospital , Helsinki , Finland – name: 9 Department of Surgery , Central Finland Central Hospital , Jyväskylä , Finland – name: 10 Department of Orthopaedics and Traumatology , Helsinki University Hospital , Helsinki , Finland – name: 12 Institute of Clinical Medicine , University of Eastern Finland , Kuopio , Finland – name: 2 Department of Surgery, Division of Orthopaedic and Trauma Surgery, Medical Research Center , Oulu University Hospital , Oulu , Finland
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Keywords	orthopedic procedures patient reported outcome measures rehabilitation tendinopathy
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PublicationCentury	2000
PublicationDate	2021-06-01
PublicationDateYYYYMMDD	2021-06-01
PublicationDate_xml	– month: 06 year: 2021 text: 2021-06-01 day: 01
PublicationDecade	2020
PublicationPlace	England
PublicationPlace_xml	– name: England – name: Kidlington – name: BMA House, Tavistock Square, London, WC1H 9JR
PublicationTitle	Annals of the rheumatic diseases
PublicationTitleAbbrev	Ann Rheum Dis
PublicationTitleAlternate	Ann Rheum Dis
PublicationYear	2021
Publisher	BMJ Publishing Group Ltd and European League Against Rheumatism Elsevier Limited BMJ Publishing Group
Publisher_xml	– name: BMJ Publishing Group Ltd and European League Against Rheumatism – name: Elsevier Limited – name: BMJ Publishing Group
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10.1136/ard.2004.021188 – volume: 17 start-page: 355 year: 2008 ident: 10.1136/annrheumdis-2020-219099_bib23 article-title: A review of the constant score: modifications and guidelines for its use publication-title: J Shoulder Elbow Surg doi: 10.1016/j.jse.2007.06.022 – start-page: 70 year: 1983 ident: 10.1136/annrheumdis-2020-219099_bib8 article-title: Impingement lesions publication-title: Clin Orthop Relat Res – volume: 391 start-page: 329 year: 2018 ident: 10.1136/annrheumdis-2020-219099_bib15 article-title: Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial publication-title: Lancet doi: 10.1016/S0140-6736(17)32457-1 – volume: 91 start-page: 1326 year: 2009 ident: 10.1136/annrheumdis-2020-219099_bib5 article-title: Does arthroscopic acromioplasty provide any additional value in the treatment of shoulder impingement syndrome?: a two-year randomised 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ident: 10.1136/annrheumdis-2020-219099_bib11 article-title: Surgery or conservative treatment for rotator cuff tear: a meta-analysis publication-title: Disabil Rehabil doi: 10.1080/09638288.2016.1198431 – volume: 86 start-page: 220 year: 2015 ident: 10.1136/annrheumdis-2020-219099_bib12 article-title: Declining incidence of acromioplasty in Finland publication-title: Acta Orthop doi: 10.3109/17453674.2014.977703 – volume: 97 start-page: 1729 year: 2015 ident: 10.1136/annrheumdis-2020-219099_bib20 article-title: Treatment of nontraumatic rotator cuff tears publication-title: J Bone Joint Surg doi: 10.2106/JBJS.N.01051 – volume: 362 start-page: 2860 year: 2018 ident: 10.1136/annrheumdis-2020-219099_bib14 article-title: Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial publication-title: BMJ doi: 10.1136/bmj.k2860 – volume: 455 start-page: 52 year: 2007 ident: 10.1136/annrheumdis-2020-219099_bib2 article-title: Indications for rotator cuff repair: a systematic review publication-title: Clin Orthop Relat Res doi: 10.1097/BLO.0b013e31802fc175 – volume: 8 start-page: 102 year: 1999 ident: 10.1136/annrheumdis-2020-219099_bib3 article-title: Arthroscopic surgery versus supervised exercises in patients with rotator cuff disease (stage II impingement syndrome): a prospective, randomized, controlled study in 125 patients with a 2 1/2-year follow-up publication-title: J Shoulder Elbow Surg doi: 10.1016/S1058-2746(99)90001-0 – volume: 7 start-page: 78 year: 1997 ident: 10.1136/annrheumdis-2020-219099_bib32 article-title: Etiology and pathophysiology of chronic tendon disorders in sports publication-title: Scand J Med Sci Sports doi: 10.1111/j.1600-0838.1997.tb00123.x – volume: 415 start-page: 111 year: 2003 ident: 10.1136/annrheumdis-2020-219099_bib10 article-title: Pathologic evidence of degeneration as a primary cause of rotator cuff tear publication-title: Clin Orthop Relat Res doi: 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Snippet	BackgroundRotator cuff disease (RCD) causes prolonged shoulder pain and disability in adults. RCD is a continuum ranging from tendinopathy to full-thickness... Rotator cuff disease (RCD) causes prolonged shoulder pain and disability in adults. RCD is a continuum ranging from tendinopathy to full-thickness tendon tear....
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SubjectTerms	Adult Arthritis Arthroscopy - methods Decompression Follow-Up Studies Hospitals Humans Informed consent Injuries Magnetic resonance imaging orthopedic procedures Pain patient reported outcome measures Patients Rehabilitation Rotator cuff Rotator Cuff - diagnostic imaging Rotator Cuff - surgery Shoulder Shoulder Pain - etiology Surgery tendinopathy Tendons Treatment Treatment Outcome
Title	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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