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SelfBack

By SelfBack

SelfBack is an evidence based, AI driven digital therapeutics solution for low back pain; developed over 5 years by World leading researchers and practitioners in the musculoskeletal and work environmental field to help patients self-manage and adhere to the best treatment possible.

Level 1

I am a CE-certified medical device

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General description
Additional info
Media

General description (provided by company)

Main purpose

SelfBack delivers a brand-new AI-driven digital therapeutics solution with clinical evidence for patients with Low Back Pain (LBP).
SelfBack was developed over the course of 5 years by a multidisciplinary team of world leading scientists in the musculoskeletal and work environmental field.
The primary functionality of SelfBack helps citizens follow a personalized treatment plan based on exercises, (both strength and flexibility), educational elements regarding LBP and physical activity through the counting of steps taken during the day.
Using AI and data, the patient is continuously monitored – also between consultations - which ensures consistently high-quality treatment for Low Back Pain and increases the insight in the treatment for the health care professional through the consistent collection and utilization of PREMs and PROMs data, as long as the patient agrees to it.
The plans are fulfilling all the requirements of the National Clinical Guidelines and SelfBack underwent an extensive test in a large scale RCT (Randomized Controlled Trial), in Denmark and Norway, back in 2019-2020, while multiple studies have been conducted afterwards. This information is found under the sections in Profile -> General.

Target audience

The users of the app are patients who have been diagnosed with non-specific low back pain through an assessment by a healthcare professional (I.e. physiotherapist, chiropractor or general practitioner), and who have also been assessed suitable for treatment with SelfBack. They must be 18 years or over and have access to a smartphone with internet access and a registered phone number able to receive text messages from their health care professional in the form of an activation code. This is clearly stated in Terms & Conditions within the app as well as within the Instructions of Use.

Approach

The personalized treatment plan and educational elements are offered on a smartphone and will be based on Artificial Intelligence. The activity data is collected through integration with Google Fit or Apple Health. Treatment plans are personalized using the answers from the questionnaires and exercise feedback the patients are highly encouraged to answer and give promptly when necessary. Duration and difficulty are then adjusted accordingly. The PREMs and PROMs data collected can be shared with the patients’ health care professional when given clear consent to do so.

Connectivity to sensors and platforms

SelfBack can be connected to a variety of platforms in the healthcare system as it was built that way. If not integrated, the only external platforms connected to SelfBack are Google Fit or Apple Health, depending on the patient’s phone. SelfBack uses no sensors or wearables.

Financing and pricing model

Payment for the app is based on a subscription model for 1 license for 1 patient with unlimited use for 3 months for €100. Renewing the license can be done at the end for further 3 months unlimited use for 1 patient. Server hosting and updates, on-going support for clinicians and users, continuous updates for the app, cyber security updates, certification maintenance etc., costs 7.5% of the total license payment in a year.

Pathology

Other Pain Rehabilitation Treatment adherence

Functions

Alerts & Notifications Automated Guidance Data Sharing Goal Setting & Gamification Health Tracking Personal Health Record Remote Clinical Monitoring Treatment Support

Users

Men Women Elderly Clinicians

Additional info

Compliance to M1 criteria

CE certification

Download document Granted by Self-declaration Assessed and certified meeting the requirements of:
Medical Device Directive: MDD 93/42/EEC (old regulation) Medical Device Regulation: MDR 2017/745 (new regulation)
Certificate granted on 13/12/2020 Certificate valid till 25/05/2024 Class type of medical device (More info): 1
ISO Standards:
ISO 13485 Quality Management Systems for Medical Devices (on company level) ISO 14155 Clinical Investigations of Medical Devices in Human Subjects ISO 14971 Risk Management of Medical Devices ISO 27000 series: Information Security Management Systems ISO 62304 Medical Device Software Lifecycle Processes ISO 62366 Application of Usability Engineering to Medical Devices

FAMHP registration and notification

Company registration number at FAMHP: 73659 Product identification code at FAMHP: 880511

General Data Protection Regulation (More info)

Company declares explicitly to be compliant with GDPR rules Company declares that the data are stored in EU only

The app is only available through prescription

Reference publication

SelfBack has been developed by a consortium consisting of world leading researchers and clinicians from:

University of Southern Denmark
Norwegian University of Science and Technology
University of Glasgow
Keele University
National Research Centre for the Working Environment Denmark
Chiropractic Knowledge Hub Denmark

Publications list:
https://www.selfback.dk/en/publications

Further, SelfBack is in use in the NHS and has been assessed positively by NICE in an Early Value Assessment:
NICE assessment: https://www.nice.org.uk/guidance/indevelopment/gid-hte10021/documents

User instructions

To download SelfBack go to the App Store or Google Play and search for "SelfBack". Once
you have found the page for SelfBack, press 'Install'. SelfBack should now be installed on
your device. Make sure your device is running Android version 8.1 or later, or iOS version 12.0 or later, otherwise you are not able to install SelfBack.

To create your account, open the app and press the “I’m a new user” button. You will now be asked to enter your activation code which you should have received from your health care professional. After entering your activation code, you will be asked to enter in your phone number. This will make you receive a 6-digit verification code to confirm your phone number. You have now created an account!

The first step to start using the app is beginning the self-management program.
SelfBack will need some information about you, and therefore you will have to answer a few questionnaires. Later on, there will be weekly follow up questionnaires which will be available throughout your use of SelfBack.
It is important to be honest when filling out the questionnaires as they create the foundation of your personal program.

Once you have completed the initial questionnaire you will be brought to the main part of the SelfBack app, where a few initial questions regarding your self-management goals will be asked.
You will now be able to see four additional questionnaires, the four questionnaires collect further data for adjustment and optimization of your plan including sleep, pain perception, everyday health, and mental health. These can be filled out when you deem fit, however we do recommend doing it as soon as possible.

To use SelfBack in your everyday life, log in each day and complete the tasks presented on the Today tab, and explore the different sections with educational elements, steps tracking, exercises, stats, achievements and toolboxes for pain relief & more.

Components of the application

Native app

Complaints handling

Via e-mail: support@selfback.dkVia telephone: +45 43 32 63 52

Media

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