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

Sanna Cederqvist, Tapio Flinkkilä, Markus Sormaala, Jari Ylinen, Hannu Kautiainen, Tero Irmola, Heidi Lehtokangas, Juho Liukkonen, Konsta Pamilo, Tero Ridanpää, Kai Sirniö, Juhana Leppilahti, Ilkka Kiviranta, Juha Paloneva, Sanna Cederqvist, Tapio Flinkkilä, Markus Sormaala, Jari Ylinen, Hannu Kautiainen, Tero Irmola, Heidi Lehtokangas, Juho Liukkonen, Konsta Pamilo, Tero Ridanpää, Kai Sirniö, Juhana Leppilahti, Ilkka Kiviranta, Juha Paloneva

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.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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.

References

    1. Mitchell C, Adebajo A, Hay E, et al. . Shoulder pain: diagnosis and management in primary care. BMJ 2005;331:1124–8. 10.1136/bmj.331.7525.1124
    1. Oh LS, Wolf BR, Hall MP, et al. . Indications for rotator cuff repair: a systematic review. Clin Orthop Relat Res 2007;455:52–63. 10.1097/BLO.0b013e31802fc175
    1. Brox JI, Gjengedal E, Uppheim G, et al. . 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. J Shoulder Elbow Surg 1999;8:102–11. 10.1016/S1058-2746(99)90001-0
    1. Haahr JP, Østergaard S, Dalsgaard J, et al. . Exercises versus arthroscopic decompression in patients with subacromial impingement: a randomised, controlled study in 90 cases with a one year follow up. Ann Rheum Dis 2005;64:760–4. 10.1136/ard.2004.021188
    1. Ketola S, Lehtinen J, Arnala I, et al. . Does arthroscopic acromioplasty provide any additional value in the treatment of shoulder impingement syndrome?: a two-year randomised controlled trial. J Bone Joint Surg Br 2009;91:1326–34. 10.1302/0301-620X.91B10.22094
    1. Seitz AL, McClure PW, Finucane S, et al. . Mechanisms of rotator cuff tendinopathy: intrinsic, extrinsic, or both? Clin Biomech 2011;26:1–12. 10.1016/j.clinbiomech.2010.08.001
    1. Brox JI. Shoulder pain. Best Pract Res Clin Rheumatol 2003;17:33–56. 10.1016/S1521-6942(02)00101-8
    1. Neer CS. Impingement lesions. Clin Orthop Relat Res 1983:70–7 10.1097/00003086-198303000-00010
    1. Paloneva J, Lepola V, Äärimaa V, et al. . Increasing incidence of rotator cuff repairs--A nationwide registry study in Finland. BMC Musculoskelet Disord : 2015;16:189. 10.1186/s12891-015-0639-6
    1. Hashimoto T, Nobuhara K, Hamada T. Pathologic evidence of degeneration as a primary cause of rotator cuff tear. Clin Orthop Relat Res 2003;415:111–20. 10.1097/01.blo.0000092974.12414.22
    1. Ryösä A, Laimi K, Äärimaa V, et al. . Surgery or conservative treatment for rotator cuff tear: a meta-analysis. Disabil Rehabil 2017;39:1357–63. 10.1080/09638288.2016.1198431
    1. Paloneva J, Lepola V, Karppinen J, et al. . Declining incidence of acromioplasty in Finland. Acta Orthop 2015;86:220–4. 10.3109/17453674.2014.977703
    1. Carr A, Cooper C, Campbell MK, et al. . Effectiveness of open and arthroscopic rotator cuff repair (UKUFF): a randomised controlled trial. Bone Joint J 2017;99-B:107–15. 10.1302/0301-620X.99B1.BJJ-2016-0424.R1
    1. Paavola M, Malmivaara A, Taimela S, et al. . Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial. BMJ 2018;362:k2860. 10.1136/bmj.k2860
    1. Beard DJ, Rees JL, Cook JA, et al. . Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial. Lancet 2018;391:329–38. 10.1016/S0140-6736(17)32457-1
    1. Vandvik PO, Lähdeoja T, Ardern C, et al. . Subacromial decompression surgery for adults with shoulder pain: a clinical practice guideline. BMJ 2019;364:l294. 10.1136/bmj.l294
    1. Tv K, Nb J, Cm P, et al. . Subacromial decompression surgery for rotator cuff disease (review). Cochrane Database Syst Rev 2019;1. 10.1002/14651858.CD005619.pub3
    1. Moosmayer S, Lund G, Seljom U, et al. . Comparison between surgery and physiotherapy in the treatment of small and medium-sized tears of the rotator cuff: a randomised controlled study of 103 patients with one-year follow-up. J Bone Joint Surg Br 2010;92:83–91. 10.1302/0301-620X.92B1.22609
    1. Moosmayer S, Lund G, Seljom US, et al. . Tendon repair compared with physiotherapy in the treatment of rotator cuff tears: a randomized controlled study in 103 cases with a five-year follow-up. J Bone Joint Surg Am 2014;96:1504–14. 10.2106/JBJS.M.01393
    1. Kukkonen J, Joukainen A, Lehtinen J, et al. . Treatment of nontraumatic rotator cuff tears. J Bone Joint Surg 2015;97:1729–37. 10.2106/JBJS.N.01051
    1. Kukkonen J, Joukainen A, Lehtinen J, et al. . Treatment of non-traumatic rotator cuff tears: a randomised controlled trial with one-year clinical results. Bone Joint J 2014;96-B:75–81. 10.1302/0301-620X.96B1.32168
    1. Lambers Heerspink FO, van Raay JJAM, Koorevaar RCT, et al. . Comparing surgical repair with conservative treatment for degenerative rotator cuff tears: a randomized controlled trial. J Shoulder Elbow Surg 2015;24:1274–81. 10.1016/j.jse.2015.05.040
    1. Constant CR, Gerber C, Emery RJH, et al. . A review of the constant score: modifications and guidelines for its use. J Shoulder Elbow Surg 2008;17:355–61. 10.1016/j.jse.2007.06.022
    1. Zelman DC, Dukes E, Brandenburg N, et al. . Identification of cut-points for mild, moderate and severe pain due to diabetic peripheral neuropathy. Pain 2005;115:29–36. 10.1016/j.pain.2005.01.028
    1. Aalto AM, Aro AR, Teperi J. Rand-36 terveyteen liittyvän elämänlaadun mittarina: Mittarin luotettavuus JA suomalaiset väestöarvot. Research reports / National Research and Development Centre for Welfare and Health. 1999.
    1. Kenward MG, Roger JH. Small sample inference for fixed effects from restricted maximum likelihood. Biometrics 1997;53:983. 10.2307/2533558
    1. Kukkonen J, Joukainen A, Lehtinen J, et al. . Treatment of nontraumatic rotator cuff tears: a randomized controlled trial with two years of clinical and imaging follow-up. J Bone Joint Surg Am 2015;97:1729–37. 10.2106/JBJS.N.01051
    1. Holmgren T, Öberg B, Adolfsson L, et al. . Minimal important changes in the Constant-Murley score in patients with subacromial pain. J Shoulder Elbow Surg 2014;23:1083–90. 10.1016/j.jse.2014.01.014
    1. Kukkonen J, Kauko T, Vahlberg T, et al. . Investigating minimal clinically important difference for constant score in patients undergoing rotator cuff surgery. J Shoulder Elbow Surg 2013;22:1650–5. 10.1016/j.jse.2013.05.002
    1. Odak S, Powell E, Temperley D, et al. . A randomized controlled trial to assess the efficacy of arthroscopic subacromial decompression with and without rotator cuff repair using a Mini-open technique. Shoulder Elbow 2012;4:112–6. 10.1111/j.1758-5740.2011.00175.x
    1. Ranebo MC, Björnsson Hallgren HC, Holmgren T, et al. . Surgery and physiotherapy were both successful in the treatment of small, acute, traumatic rotator cuff tears: a prospective randomized trial. J Shoulder Elbow Surg 2020;29:459–70. 10.1016/j.jse.2019.10.013
    1. Kannus P. Etiology and pathophysiology of chronic tendon disorders in sports. Scand J Med Sci Sports 1997;7:78–85. 10.1111/j.1600-0838.1997.tb00123.x

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner