The DiGA ViViRA is a digital app for the treatment of back pain in non-specific back pain or arthrosis of the spine (osteochondrosis) that has been finally included in the DiGA directory by the BfArM. The app can be used according to a doctor's prescription and without a doctor's prescription. It offers, among other things, personalized and therapeutic training content that adapts based on user feedback, ways to monitor training activity and disease progression, ways to test movement ability, and knowledge articles on musculoskeletal health. These instructions for use describe how to use the ViViRA app as intended.
Before using the app, a doctor should confirm that ViViRA is suitable for you and your particular health situation.
ViViRA does not provide medical or therapeutic diagnosis or treatment.
Read these instructions carefully and completely before using ViViRA. Please pay particular attention to the following sections:
Section 2: Legal requirements for the use and processing of your data.
Section 3: Technical and medical conditions for use and contraindications
Section 4: Safety Instructions and Side Effects
Training with ViViRA can be done without supervision by a doctor or therapist.
Frequency of use
Unless otherwise instructed by a doctor, you should do one ViViRA training session of 4 exercises per day, at least 3 days per week.
Duration of use
The duration of use is limited to 90 days per prescription. If further therapy is needed, follow-up prescriptions may follow. There is no general duration of use to be observed. However, in case of complaints, a doctor should be consulted.
Note
Image excerpts from the app used in the instructions for use show the display on Apple devices. The display on devices using the Android operating system may differ slightly from this display.
Questions can be sent to service@diga.vivira.com at any time.
As a prerequisite for use, you confirm at the start of the introduction that you:
You can find our currently valid privacy policy at: www.vivira.com/datenschutzerklaerung/. You can revoke your consent to the processing of your data at any time in the ViViRA app under Profile > Settings > Manage your data.
3.1. Technical requirements for the application
ViViRA is currently compatible with operating systems from Android 7.0 and iOS 14.0.
In order to be able to use the ViViRA service to its full extent, you should urgently keep both the ViViRA App and the operating system of your end device up to date ("Updates"). We recommend that you check both the operating system and the ViViRA for updates at least once a month. If older or not commonly used software is used, you may be limited or unable to use the services, or you may become a target of cyberattacks.
It is not possible to use the service without a stable broadband internet connection.
3.2. Medical condition for use
A prerequisite for using the programs is a stable general state of health.
If you experience pain, discomfort, or loss of function during or after using the app, you should stop the program and, if necessary – at your own discretion – consult a doctor.
Pause ViViRA if
3.3. Contraindications
ViViRA may only be used if none of the following absolute contraindications are present.
| ICD-10 | Description |
| G55.1 | Compression of nerve roots and nerve plexus due to disc damage |
| G99.2 | Myelopathy in diseases classified elsewhere |
| I80 | Thrombosis, phlebitis and thrombophlebitis |
| M00 | Purulent arthritis |
| M01 | Direct joint infections in infectious and parasitic diseases classified elsewhere |
| M02 | Reactive arthritis |
| M03 | Post-infectious and reactive arthritides in diseases classified elsewhere |
| M23.4 | Free joint body in knee joint |
| M24.05 | Free joint body: pelvic region and thigh (pelvis, femur, buttocks, hip, hip joint, sacroiliac joint) |
| M50 | Cervical disc damage |
| M50.1 | Cervical disc damage with radiculopathy |
| M51.0 | Lumbar and other disc damage with myelopathy |
| M51.1 | Lumbar and other disc damage with radiculopathy |
| M87 | Bone necrosis |
| M93.2 | Osteochondrosis dissecans |
| T84 | Complications due to orthopaedic endoprostheses, implants or grafts |
Acute inflammation or fever
Do not use ViViRA if you have an acute infection or fever.
Spinal or joint infection
Do not use ViViRA if you have been diagnosed with a spinal, hip or knee infection.
3.3.2. Relative contraindications
In addition to the contraindications mentioned above, there are other restrictions that you should observe so that nothing stands in the way of a successful therapy. If one of the following points applies to you, please discuss the use of ViViRA with your doctor beforehand.
| ICD-10 | Description |
| M46 | Other inflammatory spondylopathies |
| Z96.6 | Presence of orthopaedic joint implants |
| Z96.64 | Presence of a hip joint prosthesis |
| Z96.65 | Presence of a knee joint prosthesis |
| Z96.68 | Presence of other specified orthopaedic joint implants |
Under neurological treatment
Do not use the app if you are receiving medical treatment for a stroke, paralysis, MS or seizure disorder.
Previous spinal surgery
Do not use the ViViRA app if you have had spinal surgery.
Possible spine, spinal cord, knee or hip joint injuries.
Do not use the ViViRA app if your pain is due to a fall or other physical injury and has not been medically evaluated to rule out injury to the spine, spinal cord or affected joint.
Advanced heart disease
Do not use the ViViRA App if you have or have had a history of heart disease, shortness of breath after climbing less than 2 flights of stairs, or other unexplained cardiovascular conditions (e.g. palpitations, unexplained swelling of the legs, cough).
Rheumatic disease
Do not use the ViViRA App if you have a known rheumatic disease.
Decreased bone density
Do not use the ViViRA App if you have known low bone density (age-related bone loss or other medical reasons).
Gait unsteadiness or frequent falls
Do not use the ViViRA App if you have an unsteady gait, frequent falls, low blood pressure or dizziness caused by exercise.
Bleeding tendency, history of increased bleeding, or taking anticoagulant medications
Do not use the ViViRA App if you suffer from increased bleeding, if you have a hereditary bleeding disorder or if you are taking medication that inhibits your blood clotting.
Pregnancy
Do not use the ViViRA App if you are pregnant or think you may be pregnant.
Cancer
Do not use ViViRA without first consulting a doctor if you have an active cancer.
Methodological exclusion criteria specific to the study
Severe organ failure Exclusion of study participants with a history of cardiovascular events, chronic renal failure and chronic lung disease.
Acute instability of knee & hip
Exclusion of study participants with existing knee joint and/or hip joint instability.
3.4. ACCESSIBILITY
The app is not accessible and not suitable for users with visual impairments.
Caution.
Always follow your doctor's instructions regarding the exercises and movements you are allowed to perform in your particular health condition. Your doctor's instructions always take precedence over the instructions in the app and must always be followed exactly. Failure to follow your doctor's instructions when using ViViRA may result in pain and injury.
Caution.
Before performing an exercise, always pay close attention to the exercise instructions in the instruction video and always read the explanatory texts below the instruction videos. They contain important information on how to perform the exercises correctly. If you are not sure how to perform an exercise, stop it and ask your doctor or therapist. Although the exercises have been selected to be suitable for self-training at home without a doctor or therapist present, incorrect execution of the exercises can lead to pain and injury.
Caution.
Always answer carefully and truthfully the questions you are asked in the app, especially about your complaint area, medical findings, movement restrictions, pain and the ability to perform all repetitions of an exercise. Inaccurate or incorrect information in the ViViRA app may result in you being given exercises that are not suitable for you. Performing such exercises can lead to pain or injury.
Caution.
Some exercises require you to assume a quadrupedal position and a supine or prone position. If you have difficulty getting up after assuming these positions, you should not perform these exercises.
Caution.
Some exercises require you to assume toe-up positions. If you have any insecurities about standing on your toes, e.g. balance problems and/or risk of falling, you should not perform these exercises.
Non-specific back pain
Osteoarthritis of the back (osteochondrosis)
Note: Osteoarthritis is a degenerative change in the cartilage that covers the joint surfaces. Colloquially, it is also referred to as "joint wear and tear". Osteoarthritis is characterised by pain and restricted movement in the joint and is often accompanied by morning stiffness that improves with movement.
Warning: Exercise often helps with osteoarthritis pain, which can sometimes be weaker and sometimes stronger. Start exercising slowly so you don't overexert yourself. Reduce the intensity of exercise or skip painful exercises if your pain persists.
4.3. Side effects
Side effects are undesirable effects that may occur when using the app as intended. What are the possible side effects?
For the information at this point, reported side effects that occurred in at least one in 50,000 ViViRA installations were considered. We are not aware of any other side effects at the time of writing this leaflet.
Other possible side effects, although none have been reported to us by users:
4.4. Reporting adverse effects or events
If you notice an adverse effect (e.g. a discomfort or change) while using ViViRA, send us a message directly from the app (Profile > Settings > Send us a message) or email us at service@diga.vivira.com. You can also contact a doctor to report an adverse effect.
ViViRA is based on movement therapy.
"Exercise therapy is a physiotherapy procedure to increase resilience and restore normal body functions through systematic and individually adapted physical exercises." (Pschyrembel Clinical Dictionary)
Exercise therapy is part of the guidelines for the treatment of non-specific and degenerative back pain and is thus a recognised professional standard. In addition, the positive effect of exercise therapy on pain reduction has been scientifically proven.
Within the framework of movement therapy, ViViRA specifically addresses mobility (mobility), stability (strength) and coordination through regular self-exercises. "Mobility is the combination of muscle flexibility and range of motion of the joint, both together form the mobility of a body part.(...) Stability describes the maintenance of posture and the control of fundamental movements. It therefore requires strength in different joint positions, at different speeds of movement and in combinations of these. (...) Coordination, or the correct neuromuscular control, is the third essential pillar of a movement. What is meant by this is the ability of our brain to control a movement and to control its course." (Klingenberg 2019)
The ViViRA exercises were selected according to a functional training approach. They usually affect several joints and muscle groups, i.e. they follow the principle of supra-regional dependencies and related muscle chains. ViViRA training thus follows a holistic therapy approach to support the strengthening of the body in its entire range of motion.
You can find more literature on the therapy concept in the ViViRA app in the "Knowledge" section under "ViViRA therapy concept".
After installing the ViViRA app, you can either create an account directly or first find out about the ViViRA app.
To create your ViViRA account, the app will ask you to enter your email address. To verify your identity, we will send you an email with a one-time passcode that you need to enter in the app.
We also need your email address so that we can contact you with important product safety notifications. Vivira will never share your email address with third parties, more information can be found in the privacy policy.
If you have received an activation code for ViViRA from your health insurance company, you can enter it on the code activation screen. If you are using a smartphone with iOS version 16 or later or Android version 7.0 or later, you can scan the code on your health insurance letter using ViViRA's code scanner function.
When personalizing the app, you answer questions about yourself, your area of pain, any medical findings that may be available, and movement restrictions. Your training program is configured from this information.
As soon as you have set up your ViViRA account including personalization, you can use the ViViRA app for therapeutic training.
In the app, after setting up your ViViRA account, you will receive 4 exercises per day. After each exercise, you give feedback on whether the exercise triggered or intensified pain and whether you were able to perform all repetitions. The exercises in your training plan change in intensity and complexity according to your input.
Stop an exercise if it causes or worsens pain or if you notice a loss of function. See a doctor if these symptoms persist.
After performing the exercise, answer questions about pain and your ability to complete the exercise.
Stop an exercise if it triggers or worsens pain or if you notice a loss of function. Seek medical attention if these symptoms persist.
If you report pain, you will have the option to remove the exercise from your programme.
The information you provide will determine whether you increase the intensity and complexity of the exercise next time.
Caution!
Once feedback has been entered, it cannot be taken back or undone. Therefore, take special care to enter your feedback correctly.
Caution!
Removing an exercise from the program cannot be undone. The exercise will be removed permanently. Therefore, pay special attention if you want to try the exercise again in the future or remove it from the program.
The app asks you to answer a weekly progress log with seven questions about pain, limitations and your therapeutic treatment.
Every month, the app asks you to perform a movement test with 15 movements. A movement score is calculated using the information you provide after each movement.
For each movement, you get an illustration with an explanation text. You try to perform the movement as instructed.
Afterward, you answer the questions for each exercise whether you were able to perform the movement and whether you had pain during the movement.
ViViRA calculates a score for the overall movement ability and a score for mobility, strength and coordination.
The app allows you to record the steps you take every day.
You access the entry area via the Today page in the app by tapping the "Log steps" field under the exercise card.
You can enter the steps manually or, on Apple devices, have the steps automatically transferred to the Vivira app via an integration with Apple Health.
Your daily training activity, your progress log, your exercise test scores and your daily steps are visually displayed in the app so that you can follow their progress over time at any time.
If you want to share important program and progress data with a doctor or therapist, you can generate a PDF file with this data from the app. You can then print out the PDF file and present it to your doctor.
ViViRA explicitly does not recommend that you share your personal health data, e.g., in social media. Only share your personal health data in applications that guarantee the legally required level of data protection and data security, in which you know the group of recipients and in which you can determine exactly who the recipient(s) of your data are.
In addition to the training, you can read knowledge articles on musculoskeletal health topics in the app to support the training effect.
You can change your program settings at any time on the profile page and under Settings.
In Settings, you can make a variety of changes to optimize your ViViRA experience. You can set your notifications, turn your Apple Health integration on and off, and manage your data. Furthermore, you can log out of the app so that it is only accessible when you log in again.
To start your training with ViViRA, read in particular the knowledge articles “About ViViRA” in the top row of knowledge articles. These will give you a basic understanding of the ViViRA training philosophy and a suitable weekly routine. They also give tips on what can be done if exercises are either too difficult for you or not challenging enough.
Address:
Vivira Health Lab GmbH
c/o Mindspace
Krausenstr. 9-10
10117 Berlin, Germany
Instruction for use
Please read the instructions for use before using the Vivira app
Vivira is a CE marked medical device
Further information
You can find more information about the manufacturer and news about the product on our website www.vivira.com.
Vivira Health Lab GmbH
Kurfürstendamm 54/55, 10707 Berlin
Kontakt: service@diga.vivira.com
