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Abstract
Objectives To assess the long-term efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy (primary comparison), a placebo surgical intervention, and with a non-operative alternative, exercise therapy (secondary comparison).
Methods We conducted a multicentre, three group, randomised, controlled superiority trial. We included 210 patients aged 35–65 years, who had symptoms consistent with shoulder impingement syndrome for more than 3 months. 175 participants (83%) completed the 5 years follow-up. Patient enrolment began on 1 February 2005 and the 5-year follow-up was completed by 10 October 2018. The two primary outcomes were shoulder pain at rest and on arm activity measured with Visual Analogue Scale (VAS). Minimally important difference (MID) was set at 15. We used a mixed-model repeated measurements analysis of variance with participant as a random factor, the baseline value as a covariate and assuming a covariance structure with compound symmetry.
Results In the primary intention to treat analysis (ASD vs diagnostic arthroscopy), there were no between-group differences that exceeded the MID for the primary outcomes at 5 years: the mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were −2.0 (95% CI −8.5 to 4.6; p=0.56) at rest and −8.0 (−17.3 to 1.3; p=0.093) on arm activity. There were no between-group differences in the secondary outcomes or adverse events that exceeded the MID. In our secondary comparison (ASD vs exercise therapy), the mean differences between groups (ASD minus exercise therapy) in pain VAS were 1.0 (−5.6 to 7.6; p=0.77) at rest and −3.9 (−12.8 to 5.1; p=0.40) on arm activity. There were no significant between-group differences for the secondary outcomes or adverse events.
Conclusions ASD provided no benefit over diagnostic arthroscopy (or exercise therapy) at 5 years for patients with shoulder impingement syndrome.
- shoulder
- acromioplasty
- impingement
- physiotherapy
- placebo
- sham
- randomised
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Footnotes
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MP and TLJ contributed equally.
Collaborators A complete list of the FIMPACT (Finnish Shoulder Impingement Arthroscopy Controlled Trial) Investigators (and their roles and responsibilities in the execution of the trial) is provided in the online supplementary appendix.
Contributors The corresponding author attests that the writing committee and all listed collaborators meet authorship criteria and that no others meeting the criteria have been omitted. MP and TLNJ were coprincipal investigators. MP, AM, ST and TLNJ 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, KK, ST and TLNJ collected the data. ST designed the database and cleaned the data. ST, KK, TLNJ and JR contributed to the study analysis plan and data analysis. MP, KK, ST, JR and TLNJ participated in the analysis and interpretation of the data. KK, ST, MP, JR and TLNJ drafted the manuscript. All authors contributed to final data interpretation and contributed to and approved the final draft of the manuscript. TLNJ obtained funding. MP is the guarantor.Writing Committee: MP, KK, ST and TLNJ. Steering committee: MP, AM, ST and TLNJ. 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; Tampere University Hospital/ TAYS Hatanpää, 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.
Disclaimer 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 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.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Ethics approval The protocol was approved by the Institutional Review Board of the Pirkanmaa Hospital District (R04200).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request. 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.