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Research

Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial

BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k2860 (Published 19 July 2018) Cite this as: BMJ 2018;362:k2860
  1. Mika Paavola, chief surgeon1,
  2. Antti Malmivaara, chief physician2,
  3. Simo Taimela, research director1 3,
  4. Kari Kanto, consultant orthopedic surgeon4,
  5. Jari Inkinen, senior physiotherapist5,
  6. Juha Kalske, consultant orthopedic surgeon6,
  7. Ilkka Sinisaari, consultant orthopedic surgeon7,
  8. Vesa Savolainen, consultant orthopedic surgeon8,
  9. Jonas Ranstam, professor9,
  10. Teppo L N Järvinen, professor1 3
  11. for the Finnish Subacromial Impingement Arthroscopy Controlled Trial (FIMPACT) Investigators
  1. 1Department of Orthopedics and Traumatology, Helsinki University Hospital, Töölö hospital, Helsinki, Finland
  2. 2National Institute for Health and Welfare, Centre for Health and Social Economics, Helsinki, Finland
  3. 3Finnish Centre for Evidence-Based Orthopedics (FICEBO), Department of Orthopedics and Traumatology, University of Helsinki, Helsinki, Finland
  4. 4Department of Orthopedics and Traumatology, Tampere University Hospital, TAYS Hatanpää, Tampere, Finland
  5. 5Fysios Finlayson, Physiotherapy Centre Kunnon Klinikka Oy, Tampere, Finland
  6. 6Department of Orthopedics and Traumatology, Helsinki University Hospital, Jorvi Hospital, Espoo, Finland
  7. 7Terveystalo, Helsinki, Finland
  8. 8Pohjola Hospital, Helsinki, Finland
  9. 9Department of Clinical Sciences Lund, Orthopedics, Lund University, Lund, Sweden
  1. Correspondence to: M Paavola mika.paavola{at}hus.fi
  • Accepted 8 June 2018

Abstract

Objective To assess the efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy, a placebo surgical intervention, and with a non-operative alternative, exercise therapy, in a more pragmatic setting.

Design Multicentre, three group, randomised, double blind, sham controlled trial.

Setting Orthopaedic departments at three public hospitals in Finland.

Participants 210 patients with symptoms consistent with shoulder impingement syndrome, enrolled from 1 February 2005 with two year follow-up completed by 25 June 2015.

Interventions ASD, diagnostic arthroscopy (placebo control), and exercise therapy.

Main outcome measures Shoulder pain at rest and on arm activity (visual analogue scale (VAS) from 0 to 100, with 0 denoting no pain), at 24 months. The threshold for minimal clinically important difference was set at 15.

Results In the primary intention to treat analysis (ASD versus diagnostic arthroscopy), no clinically relevant between group differences were seen in the two primary outcomes at 24 months (mean change for ASD 36.0 at rest and 55.4 on activity; for diagnostic arthroscopy 31.4 at rest and 47.5 on activity). The observed mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were −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 between group differences were seen between the ASD and diagnostic arthroscopy groups in the secondary outcomes or adverse events. In the secondary comparison (ASD versus exercise therapy), statistically significant differences were found in favour of ASD in the two primary outcomes at 24 months in both VAS at rest (−7.5, −14.0 to −1.0, points; P=0.023) and VAS on arm activity (−12.0, −20.9 to −3.2, points; P=0.008), but the mean differences between groups did not exceed the pre-specified minimal clinically important difference. Of note, this ASD versus exercise therapy comparison is not only confounded by lack of blinding but also likely to be biased in favour of ASD owing to the selective removal of patients with likely poor outcome from the ASD group, without comparable exclusions from the exercise therapy group.

Conclusions In this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months.

Trial registration Clinicaltrials.gov NCT00428870.

Footnotes

  • Contributors: The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. MP and TJ were co-principal investigators. MP, AM, ST, and TJ conceived and designed the study, and JI also contributed to the design. KK, JK, IS, and VS recruited most of the patients, FIMPACT Investigators followed up the patients. MP, AM, ST, KK, and TJ collected the data. ST designed the database and cleaned the data. ST, TJ, and JR contributed to the study analysis plan and data analysis. MP, ST, KK, AM, JR, and TJ participated in the analysis and interpretation of the data, JR led the blinded data analysis process. TJ, ST, KK, MP, JR, and AM drafted the manuscript. All authors contributed to final data interpretation and contributed to and approved the final draft of the manuscript. TJ obtained funding. MP is the guarantor.

  • Steering Committee: MP, TJ, AM, and ST.

  • Writing Committee: TJ, ST, MP, KK, and AM.

  • Participating investigators (FIMPACT Investigators): Mika Paavola, Teppo Järvinen, Simo Taimela, Antti Malmivaara, Kari Kanto.

  • Participating clinical sites: Helsinki University Hospital, Jorvi Hospital: Kalevi Hietaniemi, Juha Kalske, Vesa Lepola, Jyrki Salmenkivi, Sikri Tukiainen; Helsinki University Hospital, Herttoniemi Hospital: Jarkko Pajarinen, Mikko Salmela, Vesa Savolainen, Ilkka Sinisaari; Hatanpää City Hospital, Tampere: Timo Järvelä, Kari Kanto, Janne Lehtinen, Mikael Salmela.

  • FIMPACT Methods Centre: Leena Caravitis, Sari Karesvuori, Pirjo Toivonen (project management), Mathias Bäck (data management), Ville Haapamäki (imaging), Jari Inkinen (physiotherapy), Esa Läärä (randomisation), Harri Sintonen (health related quality of life outcomes).

  • Funding: The FIMPACT trial was supported by the Sigrid Juselius Foundation, the state funding for university level health research (Tampere and Helsinki University Hospitals), the Academy of Finland, and the Jane and Aatos Erkko Foundation. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. Sponsors had no access to the data and did not perform any of the study analysis. The corresponding authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.

  • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work other than those described above; ST reports personal fees from Evalua group of companies, personal fees from DBC group of companies, and personal fees from insurance companies, outside the submitted work; KK reports an honorarium for a lecture from Linvatec, outside the submitted work; TLNJ reports an honorarium for a lecture on osteoporosis from AMGEN (donated to AllTrials campaign); no other relationships or activities that could appear to have influenced the submitted work.

  • Ethical approval: This study was approved by the Institutional Review Board of the Pirkanmaa Hospital District (R04200; 28 December 2004), and informed consent was obtained from all patients.

  • Data sharing: FIMPACT data are not publicly available owing to data privacy issues, but access to the anonymised dataset can be obtained from the corresponding author on reasonable request.

  • Transparency: The lead author affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

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