Instructions For Use Kaia Back Pain

Kaia Back Pain

Instructions for Use

If you want to get a paper version of the instructions for use, please contact our support at support@kaiahealth.de.

• Revision: 10, 2023-01-24
• Revision: 11, 2023-07-31
• Revision: 12, 2024-06-14

Table of Contents

Welcome to Kaia Back Pain

1. The Kaia Back Pain therapy concept
   1. How Kaia Back Pain works
   2. When can Kaia Back Pain be used (intended use and indications)?
   3. When should Kaia Back Pain not be used (contraindications)?
   4. Known side effects of Kaia Back Pain
2. Your daily program
   1. Course overview
   2. Movement
   3. Motion Coach
   4. Relaxation practices
   5. Knowledge
3. The Kaia Back Pain App
   1. The “Today” tab
   2. The “Progress” tab
   3. The “Browse” tab
   4. The “Help” tab
   5. The “Settings” tab
4. Building habits
   1. Make concrete plans
   2. Set realistic goals
   3. Give yourself a reward
5. Getting in touch
6. Technical information
   1. Install the app
   2. Uninstall the app
   3. Update the app

Appendix

1. Hardware and software compatibility
2. Label & symbols

Welcome to Kaia Back Pain: Ease your pain at home

Thank you for choosing Kaia Back Pain to be a part of your pain relief. Congratulations on taking the first step

If you are reading this, then you are one of millions around the world suffering from back pain. The good news is, you’ve taken an important first step towards better back health. Together with thousands of other users you decided to become active against back pain. The Kaia Back Pain program can be done in just minutes per day. Schedule a quick session before work, during your lunch break and even while you travel! It is easy to use in the comfort of your home, engaging and entertaining.

This document contains important information to help you get started with Kaia Back Pain. Keep in mind that your doctor is still the best person to provide you with information about your diagnosis and answer any medical questions you might have. If you have questions about signing-up for Kaia Back Pain or reimbursement by your private statutory health insurance, please contact our Customer Support at support@kaiahealth.de.

Let’s get started!

1. The Kaia Back Pain therapy concept

WARNING: Read these instructions carefully before use. Before using Kaia Back Pain, consult a doctor to make sure you are cleared to be physically active with your back pain.

1.1 How Kaia Back Pain works

Kaia Back Pain is a digital application that is based on the evidence-based concept of multimodal pain therapy.

This means through different therapy elements, Kaia Back Pain encourages you to become physically active and to proactively manage your back pain. Kaia Back Pain combines several approaches that have proven to be particularly effective when used together.

The therapy program consists of 3 different elements:

• Movement - Physical exercise routines tailored to your specific capabilities and needs, with varying levels of difficulty.
• Relaxation Practices - Using the latest findings from mindfulness and progressive muscle relaxation, Kaia Back Pain helps your brain and body to cope with pain in a gentle but effective way.
• Knowledge - Understanding the cause of your back pain and the connections in your body helps you to manage it more efficiently.

Your therapy starts with a questionnaire to determine your baseline condition. Your answers help us understand your back pain better and allow us to tailor the workouts to your needs.

The application can help you relieve your back pain symptoms such as pain or restricted movement.

We advise our users to follow the instructions as closely as possible. This way you can use Kaia Back Pain safely and get most out of the program. Kaia Back Pain should ideally be used between 3 and 7 times a week unless your doctor has instructed you otherwise. Use of Kaia Back Pain can contribute to improving common complaints associated with low back pain like the intensity of pain or impaired movement.

WARNING: If you experience severe pain or loss of function in any body part during or after the use of Kaia Back Pain, stop the exercise immediately and consult a physician.

1.2 When can Kaia Back Pain be used (intended use and indications)?

Kaia Back Pain is intended for multidisciplinary rehabilitation of non-specific back pain (M54.-) that has persisted for longer than 4 weeks and for multidisciplinary rehabilitation following previous episodes of non-specific back pain. Patients can use the app with or without current or past supervision from medical professionals but need to have undergone prior medical examination to exclude causes for back pain that would require specific treatment. The app is designed to be used directly by laypersons in a home setting without prior training.

WARNING: Kaia Back Pain cannot diagnose your conditions or injuries and cannot safely exclude potentially dangerous causes for your back pain. Do not use Kaia Back Pain in lieu of medical consultation. Please consult your physician if you have any questions related to diagnosis.

1.3 When should Kaia Back Pain not be used (contraindications)?

WARNING: You should only use Kaia Back Pain if you do not have any of the contraindications listed below.

Do not use Kaia Back Pain if you have trouble understanding any part of the instructions or if you do not speak English well enough to fully understand the instructions given in the app.

Contraindications with ICD-10 code

• Potential spinal injury or fracture (T09.- / M51.-)
  Do not use Kaia Back Pain if your back pain:
  • Is related to a fall or other serious injury, and
  • Has not been examined by your doctor to rule out spinal damage
• Decreased bone density (M80.- / M81.- )
  Do not use Kaia Back Pain if you have a history of low bone density (bone loss related to age or other medical reasons) unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia Back Pain.
• Spinal tumor (D48.- / C79.5)
  Do not use Kaia Back Pain if you have or have had any of the following unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia Back Pain:
  • Spinal tumor
  • History of cancer
  • Excessive night sweating, unexplained weight loss, and/or unexplained fatigue
• Spinal infection (M46.-)
  Do not use Kaia Back Pain if you have or have had any of the following unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia Back Pain:
  • History of unexplained fever
  • Recent bacterial infection
  • Unexplained potential symptoms of infection (feeling ill and/or tired)
  • Recent injection anywhere in the body
• Disc herniation (M51.-)
  Do not use Kaia Back Pain if you have or have had any of the following unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia Back Pain:
  • History of feeling numb or weak in your legs
  • Loss of feeling in the genital area
  • Bowel or bladder incontinence
• Previous spinal surgery (Z98.-)
  Do not use Kaia Back Pain if you have had previous spinal surgery unless your doctor has given you a medical exam and cleared you for physical exercises such as those in Kaia Back Pain.
• Advanced heart disease (I50.- / I51.-)
  Do not use Kaia Back Pain if you have or have had any of the following unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia Back Pain:
  • History of heart disease
  • Shortness of breath after climbing less than 2 flights of stairs
  • Other unexplained cardiovascular (related to the heart and blood vessels) complaints (such as heart palpitations, leg swelling, and cough)
• Conditions affecting your control over your lower body (from hips to toes) (G82.-)
  Do not use Kaia Back Pain if you have any conditions affecting your control over your lower body (such as a neurological condition) unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia Back Pain.
• Musculoskeletal problems affecting major joints in the lower body (M25.-)
  Do not use Kaia Back Pain if you have any conditions causing pain or reduced movement in the major joints of your lower limbs unless your doctor has given you a medical exam and cleared you for physical exercises such as those used in Kaia Back Pain.
• Pregnancy (O09.-)
  Do not use Kaia Back Pain if you are or think you may be pregnant.
• Gait imbalance (R26.-), history of falls (R29.6)
  Do not use Kaia Back Pain if you have or have had any of the following unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia Back Pain:
  • Walking imbalance
  • History of falling
  • Dizziness or low blood pressure brought on by exercise
• Coagulopathy (D68.-) or history of bleeding event
  Do not use Kaia Back Pain if you have or have had any of the following unless your doctor has given you a medical exam and cleared you to do physical exercises such as those used in Kaia Back Pain:
  • History of hemorrhage (excessive bleeding from a blood vessel)
  • Bleeding disorder

Relative contraindications

• Do not use Kaia Back Pain if you are under 18 years of age

1.4 Known side effects of Kaia Back Pain

The following side effects have been reported with regular physical activity and with the use of Kaia Back Pain in the past:

• Changes of back pain intensity and temporary pain in previously pain-free areas of the body
• Pain in neck muscles during or after exercises
• Unpleasant sensations during exercise like snapping sensations (sliding of tendons over bony structure) or temporary dizziness
• Cramps in muscles during or after exercise

If these complaints are persistent for longer than a few days, please consult a physician.

2. Your Daily Program

Kaia Back Pain offers an extensive training program that includes knowledge, workout, and relaxation courses. As previously mentioned, such a multimodal pain therapy is particularly effective for treating back pain. Kaia Back Pain is unique because it provides a new, personalized mix of your therapy program every day.

From the “Today” tab you can start any session of your selected courses. To begin an exercise, tap on a course and then select “Start”.

2.1 Course overview

You can customize your Daily Program by joining and leaving courses. To enroll in a course, select the “Settings” tab on the bottom of the screen. From the “Settings” screen, select “Course enrollment” to see an overview of your courses.

Tap on a course to add it to your daily schedule. The courses you are enrolled in are marked with a dark blue check-mark icon. You can leave courses at any time - the only course that is a fixed part of your therapy program is the workout course.

Each course consists of several units. In your Daily Program, you’ll receive one unit or exercise each day for every course in which you are enrolled.

2.2 Movement

Physical exercises are the cornerstone of your daily therapy program. Kaia Back Pain will select the best physical exercises for you every day based on the answers you provided when you completed your initial questionnaire and the feedback you give after each exercise session. To start your daily physical exercise session, select “See exercises” in the “Today” tab and tap on the dark blue “Start the session” button.

You can adjust the length of the workout by selecting the desired length for the training or number of exercise rounds before beginning your workout. Once you start your Daily Program, the exercise videos will be loaded into Kaia Back Pain.

Please note: We recommend connecting to WiFi each time you use Kaia Back Pain to ensure best performance. If you choose not to connect to WiFi, please check with your network service provider regarding data usage and overages.

Step 1: Instruction video

Before each physical exercise, Kaia Back Pain will show you a short introduction explaining the exercise. Be sure to pay close attention to how the exercise is done and how to maintain proper form. If you forget the instructions or need a reminder, you can always revisit the introduction video during the exercise session. To do this, press the “Pause” button in the bottom left and then the white “Instructions” icon on the bottom right.

Step 2: Doing your Kaia Back Pain physical exercises

After the instructions, it’s your turn to exercise! For static exercises (without fluid movements), Kaia Back Pain will show you the exact position to hold. For dynamic exercises (with fluid movements), you will be shown how to properly perform the movements.

Simply do the exercise for the duration indicated by the timer in the bottom-right corner of the exercise video screen. To pause your training, press the “Pause” button on the bottom left. To stop your exercise, select the white “X” button in the top-right corner.

Please note: If you stop the exercise, progress will not be saved.

Pausing exercises

Once you’ve paused the exercise, you will be shown the “Pause” screen. From this screen, you can skip the exercise, cancel the training, or revisit the instructions by tapping on the respective button. You can add exercises to your “Favorites” by clicking the “Favorite” star button. These exercises can be found and revisited in the “Browse” tab under “Favorites” at the bottom of the screen.

You can also add exercises to your “Favourites” at the beginning of a physical exercise in the “Exercise Overview” by tapping on the “Favorite” star button.To save your favorite exercises during exercising: First, tap the “Pause” button. From the “Pause” screen, click the “Favorite” star button to save the exercise to “Favorites”.

At the end of each exercise, you can adjust the level of difficulty and remove exercises that are painful for you at the end of your training session.

What makes training effective is different for everyone, focus on finding a rhythm that works for you and your everyday life. Where you do the Kaia Back Pain workout is entirely up to you. Many of our users find it helpful to always do the exercises in the same place. This makes it easier to develop a routine and to integrate the exercises regularly into your daily life. Experiment with when and where the Kaia Back Pain exercises fit best into your daily routine until you find what works for you. The most important thing is that you stick to your Kaia Back Pain program regularly!

2.3 Kaia Motion Tracking Technology

Unsure if you’re doing the exercises correctly? We’ve got you covered. Our digital trainer can help ensure that you’re using proper form when performing exercises.

Our Motion Tracking Technology analyzes your movements during your physical exercises using your device’s camera. It gives you real-time feedback and suggestions on how to perform each exercise better and more accurately.

You can click on the running-figure “Motion Tracking” icon directly during Kaia Back Pain workouts to get real-time assistance with exercise correction. After you tap the “Motion Tracking” button, the exercise will automatically resume where you left off, with Motion Tracking now enabled. Follow the instructions and adjust to the feedback given by Motion Coach for the best experience possible.

Alternatively, you can start the Motion Tracking enabled exercises, independent of your Daily Program, from the “Browse” tab.

2.4 Relaxation practices

Relaxation is another vital component of your Kaia Back Pain Daily Program.

Scientific research has shown that specific relaxation techniques can help to reduce pain levels sustainably and effectively. This is especially true for persistent back pain. Kaia Back Pain focuses on two different relaxation techniques: mindfulness and progressive muscle relaxation. You can participate in both these techniques by enrolling in or leaving the respective courses in the course overview.

Relaxation practices are included in your Daily Program. To start a relaxation practice, select a relaxation unit from the “Today” tab and tap “Start”. Kaia Back Pain will then play an audio recording that will guide you through the entire exercise. After completing the exercise you can continue directly with the next course of your Daily Program.

2.5 Knowledge

In the knowledge session, Kaia Back Pain provides you with comprehensive knowledge about the causes and effects of back pain. Understanding the causes of your pain will help you actively address them better. Here you can learn more about back pain and what strategies you can use to relieve it. These knowledge sessions consist of interactive text elements and short videos.

The information is presented to you in an interactive chat format. You can choose how you want to continue in each unit from a variety of options, allowing you to select which topics you want to learn more about.

3. Kaia Back Pain

In Kaia Back Pain, you will find five different areas accessible via the bottom bar - also called tabs. These five areas are:

1. “Today“
2. “Progress”
3. “Browse”
4. “Help”
5. “Settings”

3.1 Tab “Today“

The “Today” tab is the hub of Kaia Back Pain. This is where you will find your Daily Program, which includes the units of the courses in which you are currently enrolled or that are recommended to you. Tap the “See exercises” button to start your daily physical exercises or select any other content on the screen to get active.

3.2 The “Progress” tab

After your first day with Kaia Back Pain, you will be asked to briefly rate your pain intensity and sleep quality before continuing with the program’s next day. In the “Progress” tab, you’ll find an overview of these self-reported daily stats. Regularly asking about your pain intensity and sleep quality will help you and your doctor continue to improve your back pain treatment. Your answers to these questions will be displayed in the “Progress” section. Here you will also find the Biometric Assessment Test (BAT), which allows you to measure your progress using Kaia Motion Tracking Technology. This involves performing squats and toe reaches on a weekly basis.

3.3 The “Browse” tab

In the “Browse” tab, you’ll find an overview of the different physical exercises in Kaia Back Pain. Here, you can review the video instructions for exercises, activate Motion Tracking for a particular exercise, or see an overview of your last exercises as well as a list of your favorites.

3.4 The “Help” tab

For further information about Kaia Back Pain, you can chat with Kaia Back Pain Customer Support. You can always contact us from the “Help” tab. Please keep in mind that this is not a live chat. Your message will be answered within 24 hours. Alternatively, you can contact us via email at support@kaiahealth.de or via phone at +49 89 904226740 between 9.30an and 5.00pm (from Monday to Friday).

IMPORTANT INSTRUCTIONS

1. Kaia is not a replacement for medical advice. Please consult your physician if you have any medical questions.
2. Always adhere to the instructions given in Kaia Back Pain and be sure to give honest answers to the questions asked during sign-up and after the physical exercises in Kaia Back Pain.
3. Your Kaia Back Pain account contains personal information and allows us to customize your program for you. Therefore, never share your Kaia account with other people. Please note that the use of Kaia is limited to private, non-shared devices.
4. Update your app as soon as we notify you about an update, as it may contain important security-related content.

3.5 The “Settings” tab

In the “Settings” tab, you can update your personal information, view legal documents and adjust other settings.

Once on the “Settings” screen, you’ll see the following sections:

• Weekly schedule: Here, you can set your desired weekly training schedule as well as reminders for your training days.
• Removed exercises: In this section, you can see all the exercises that you have removed after a training session and you have the option to add them back to your training program.
• Gender: In this section, you can specify your gender (female, male, or other).
• Course enrollment This section enables you to access your Kaia Back Pain course overview. Here, you will find course suggestions. You can subscribe and unsubscribe to these courses and thus influence which courses are displayed in your current Kaia Daily Program.
• Activation: Here, you can access details about your current Kaia Back Pain access. Once your prescribed access expires, it won’t renew automatically and you do not need to cancel.
• Manage your data: Here, you can export your data as a PDF or in a machine-readable format. You can also show a printout or a digital version of your training history to your doctor to discuss your progress with Kaia Back Pain. You also have the option of uploading your therapy progress to your electronic patient health record (ePA). You can also view, revoke and grant consent for data processing, as well as delete your user account and all associated data.
• General & legal: Here, you can adjust other settings such as your notifications, including enabling or disabling push notifications, your email address, or your password. In this section, you can also adjust the language used in Kaia Back Pain and view legal information, such as terms and conditions and privacy policy, and software licenses.
• Help Center: Here, you can access detailed instructions on how to access the sections and their corresponding features in the “Settings” screen, as well as information on how to contact the Kaia Customer Support team.
• Log out: You can log out of Kaia Back Pain by tapping the “Log out” button. You have the option to Log in again at any time. Your account will not be deleted.

4. Building habits

We all have different ways of approaching change in our lives. While some can instantly add a new habit, others need more time to adjust. Whatever your situation, the key to implementing long-term change is to form habits. Below is some advice that has helped Kaia Back Pain users make the most of Kaia Back Pain and their therapy program.

4.1 Make concrete plans

Getting started with Kaia Back Pain is easier when you set a fixed time in your schedule to do your Daily Program: the more concrete, the better. For example, set your training schedule to do your physical exercises every Monday, Wednesday, Friday, and Saturday. Make sure you have your workout clothes and exercise mat set up and ready to go.

For some of our users, it helps to always do the physical exercises in the same room. However, Kaia Back Pain allows you to train anytime and anywhere, so feel free to try different locations and times to see what works best for you. This makes it easier for you to make your workouts a habit.

The relaxation exercises are ideal for cooling down after the physical exercises or before going to bed to help you fall asleep.

4.2 Set realistic goals

Trying to achieve goals by relying on implementing radical changes will often result in failure. There is a reason that New Year’s resolutions rarely work; we are just not made to completely change deeply rooted behavior in a short amount of time. What works, however, is making small changes that are easier to stick to.

If it’s been a while since you’ve played a sport or exercised, start with one or two exercise days per week. If you’re new to relaxation, plan short sessions so you aren’t overwhelmed. You can always increase the frequency and duration of your training later. The most important thing is to get started! Make sure to follow your doctor's instructions as well.

4.3 Don’t get discouraged

Kaia Back Pain can help improve your quality of life significantly over time but getting there can be challenging. Setting up a routine isn’t easy, so don’t be too hard on yourself if you miss a training session or two. Don’t get discouraged; just go back to where you left off. For extra motivation, try giving yourself a little reward when you achieve your goals!

5. Getting in touch

kaia health software GmbH (abbreviated as Kaia in the text)
Herzog-Wilhelm-Strasse 26
80331 Munich
Germany
support@kaiahealth.de

Note. If you or your doctor notice any deterioration in your health that may be linked to use of Kaia Back Pain, please reach out to us under the contact information provided above.

Please reach out to us if you require a paper copy of the Instructions for Use.

Kaia Back Pain is a medical device of class IIa.

6. Technical information

6.1 Install the app

How to install Kaia Back Pain on Android

1. Go to the Google Play™ store on your computer, smartphone, or tablet (make sure you have an active Internet connection).
2. Tap on the search bar.
3. Type “Kaia Back Pain”.
4. Look for the blue-circle Kaia logo.
5. Tap on “Install” and monitor the installation progress.
6. Once the app is installed, the “Install” button will change to “Open.”
7. Tap on “Open” to launch the app.

How to install Kaia Back Pain on iOS

1. Go to the Apple App Store on your computer, smartphone, or tablet (make sure you have an active Internet connection).
2. Tap on the search tab.
3. Type “Kaia Back Pain” in the search bar.
4. Look for the blue-circle Kaia logo.
5. Tap on the Download icon and monitor the installation progress.
6. You can stop the installation by tapping on the Stop button.
7. Once the app is installed, the Download button will change to Open. Tap on Open to launch the app.

6.2 Uninstall the app

How to uninstall Kaia Back Pain on Android

1. Open Android settings.
2. Go to the Apps section.
3. Search for Kaia Back Pain and tap on it.
4. Tap on the Uninstall button to uninstall the app.

How to uninstall Kaia Back Pain on iOS

1. Press the screen for 2 seconds until the app icons “wobble.” Then, tap on the minus sign on the top-left side of the Kaia Back Pain icon.
2. Tap Delete to uninstall Kaia Back Pain.

6.3 Update the app

How to update Kaia Back Pain on Android

1. Open the Google Play™ store (make sure you have an active Internet connection).
2. Tap on the search bar.
3. Type “Kaia Back Pain” in the search bar.
4. Tap on the Update button.
5. Wait for the download to complete.
6. Tap on Open to access the update.

How to update Kaia Back Pain on iOS

1. Open the Apple App Store (make sure you have an active Internet connection).
2. Tap on the search bar.
3. Type “Kaia Back Pain” in the search bar.
4. Tap on the Update button.
5. Wait for the download to complete.
6. Tap on Open to access the update.

6.4 Best Practices for Using the Kaia App Securely

To ensure a safe and secure experience while using the Kaia app, we recommend following these best practices:

1. Protect Your Personal Information

Use Strong Passwords: Create a strong and unique password for your Kaia account. Avoid using common words, easily guessed phrases, or the same password for multiple accounts.

Enable Two-Factor Authentication (2FA): Activate two-factor authentication to add an extra layer of security to your account. This requires both your username and password, as well as a second authentication factor such as passkeys.

Keep Personal Details Private: Be mindful of the personal information you share within the Kaia mobile application. Avoid posting sensitive data, if it is outside of the scope of your treatment.

2. Secure Your Devices

Update Your App and Device: Regularly update the Kaia app and your device’s operating system to ensure you have the latest security patches and features.

Use a Device Passcode: Set up a secure passcode or biometric authentication (fingerprint or face recognition) on your device to prevent unauthorised access.

Install Security Software: Be Cautious with Public Wi-Fi: Avoid using public Wi-Fi networks to access the application. If necessary, use a virtual private network (VPN) to secure your connection and protect your data from potential hackers.

3. Protect Your Privacy

Be Cautious with Public Wi-Fi: Avoid using public Wi-Fi networks to access the application. If necessary, use a virtual private network (VPN) to secure your connection and protect your data from potential hackers.

4. Stay Vigilant

Recognise Phishing Attempts: Be wary of emails, messages, or links claiming to be from Kaia that ask for personal information. Kaia will never ask for your password or any sensitive details via email or phone.

Report Suspicious Activity: If you notice any unusual activity in your account or suspect unauthorised access, contact Kaia’s support team immediately.

5. Regularly Back Up Your Data

Data Backup: Regularly backup your app data to a secure location. This ensures that your progress and settings are not lost in case of an issue with your device.

6. Review Privacy Settings

Privacy Policy: Review Kaia’s privacy policy to understand how your data is collected, stored, and used.

Appendix

i. Hardware and software compatibility

iOS

On iOS, all Apple smartphone and tablet models running iOS 16.4 or later are supported.

Android

On Android, Kaia Back Pain can be installed and run on all smartphone and tablet models running the Android 9 (Pie) operating system or later, if they meet Google's requirements for Android version 9 or later.

A list of Android devices for which Kaia ensures the correct functionality of Kaia Back Pain through periodic review can be found at https://kaiahealth.de/rueckenschmerzen/.

ii. Label* & symbols

	CE registration mark with notified body number. Indicates compliance with the requirements of the EU 2017/745 Medical Device Regulations
	Manufacturer
	Consult the operating instructions

*Please check the Contact page in the Settings screen of the app for the latest version, build date and UDI information