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Rehabilitation medicine
Protocol
Evaluation of a digital platform for osteoarthritis treatment: study protocol for a randomised clinical study
  1. Håkan Nero1,2,
  2. Jonas Ranstam1,
  3. Aliasghar Ahmad Kiadaliri3,
  4. Leif E Dahlberg2,4
  1. 1 Orthopedics, Department of Clinical Sciences Lund, Lund University, Lund, Sweden
  2. 2 Joint Academy, Malmö, Sweden
  3. 3 Clinical Epidemiology Unit, Department of Clinical Sciences Lund, Lund University, Lund, Sweden
  4. 4 Orthopedics, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden
  1. Correspondence to Dr Håkan Nero; hakan.nero{at}med.lu.se

Abstract

Introduction Despite favourable results from structured face-to-face treatment of osteoarthritis (OA) in Sweden through the Better management of patients with OsteoArthritis (BOA) initiative, only around 20% of people with knee or hip OA receive the primary treatment recommended by international guidelines (ie, information, exercise, weight management). In 2014, a digital treatment programme named Joint Academy was introduced in Sweden, based on the same concept as the face-to-face BOA programme. In line with BOA, Joint Academy follows national and international guidelines and best practice for OA treatment. Results from observational studies suggest that this digital treatment is a valuable alternative to the traditional treatment approach and can positively impact patients’ function and pain. However, conclusions from such studies commonly suggest that more rigorous testing is necessary to ascertain the benefits of digital treatment delivery for people with OA.

Methods and analysis A randomised clinical trial will be performed, comparing regular face-to-face care according to BOA with the digital version, Joint Academy. A total of 270 participants with clinically diagnosed knee OA will be recruited at primary care centres and randomised to either standard treatment (BOA) for 3 months, or the experimental group (digital intervention programme). Both groups will receive educational sessions and exercises yet with a difference in programme deliverance. The objective of the trial is to evaluate the effectiveness of the online treatment programme, in comparison with BOA. The two treatment groups will be compared with respect to the number of repetitions of the 30 s chair stand test at 3, 6 and 12 months, using a mixed model repeated measures analysis of variance.

Ethics and dissemination Ethical approval has been attained from the Regional Board of Ethics in Lund, Sweden (Dnr 2017/719). Results will be published in peer-reviewed journals.

Trial registration number NCT03328741.

  • adult orthopaedics
  • knee
  • telemedicine

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/.

https://doi.org/10.1136/bmjopen-2018-022925

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    Footnotes

    • Contributors HN, JR, AAK and LED designed the study. HN wrote the first draft of the manuscript and together with JR, AAK and LED revised the manuscript and produced the final draft. All authors have read and approved the final version of the manuscript. For this protocol and the final trial report, no ghost authors, guest authors or professional medical writers have or will be used and author eligibility is and will be based upon the ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals.

    • Funding This work has been supported by the Swedish Rheumatism Association (R-753221), Stiftelsen för bistånd åt rörelsehindrade i Skåne and Vinnova (2016-04187). Non-financial support in the form of assistance in reaching potential participating healthcare units has been received from the BOA register, while non-financial support from Arthro Therapeutics comes in the form of technical assistance in matters regarding the digital platform.

    • Disclaimer The study sponsors and funders have had no role in study design; collection, management, analysis and interpretation of data; writing of the report; or the decision to submit the report for publication, and do not own ultimate authority over any of these activities.

    • Competing interests HN is hired as a part-time consultant for Arthro, the corporation behind JA, and LED is the unemployed CMO of Arthro.

    • Patient consent Not required.

    • Ethics approval Regional Board of Ethics, Lund University, Sweden (Dnr 2017/719).

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