Contact (EU and non-US countries)

Responsible

VAT ID: DE305934424
Court: Munich, Amtsgericht München HRB 224467
Managing Director: Graham Lewis
Responsible person according to German law § 55 Abs. 2 RStV: Graham Lewis

For media enquiries and interviews

Kaia Back Pain is a medical device of class IIa.

Intended use

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.

Indication

• Non-specific back pain (M54.-)

Contraindications

• Potential spinal injury or fracture (T09.- / M51.-)
• Decreased bone density (M80.- / M81.-)
• Spinal tumor (D48.- / C79.5)
• Spinal infection (M46.-)
• Disc herniation (M51.-)
• Previous spinal surgery (Z98.-)
• Advanced heart disease (I50.- / I51.-)
• Conditions affecting your control over your lower body (from hips to toes) (G82.-)
• Musculoskeletal problems affecting major joints in the lower body (M25.-)
• Pregnancy (O09.-)
• Gait imbalance (R26.-) or tendency to fall (R29.6)
• Coagulopathy (D68.-) or history of bleeding event

Sources for the health information provided in the app, as well as sources for the medical content and procedures implemented in the app, such as guidelines, textbooks, and studies

• Arnold B, Brinkschmidt T, Casser HR, et al. Multimodale Schmerztherapie für die Behandlung chronischer Schmerzsyndrome. Schmerz 2014;28(5):459-72. DOI: 10.1007/s00482-014-1471-x.
• Europäische Leitlinie für unspezifische Kreuzschmerzen Becker A, Hildebrandt J, Müller G. Europäische Leitlinie für den Umgang mit unspezifischen Kreuzschmerzen. Deutsche Zusammenfassung. 2006 [cited: 2007 Mar 23].
• Guzman J, Esmail R, Karjalainen K, et al. Multidisciplinary rehabilitation for chronic low back pain: systematic review. BMJ 2001;322(7301):1511-6.
• Kamper SJ, Apeldoorn AT, Chiarotto A, et al. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain. Cochrane Database Syst Rev 2014;9:CD000963. DOI: 10.1002/14651858.CD000963.pub3. http://www.ncbi.nlm.nih.gov/pubmed/25180773.
• Leitlinie DEGAM Kreuzschmerzen
  Deutsche Gesellschaft für Allgemeinmedizin und Familienmedizin (DEGAM). Kreuzschmerzen. Düsseldorf: DEGAM; 2007 (DEGAM-Leitlinie; 3).
• Liddle SD, Gracey JH, Baxter GD. Advice for the management of low back pain: a systematic review of randomised controlled trials. Man Ther 2007;12(4):310-27. http://www.ncbi.nlm.nih.gov/pubmed/17395522.
• National Institute for Health and Care Excellence. Low back pain and sciatica in over 16s: assessment and management. www.nice.org.uk/guidance/ng59. Published 30. November 2016
• Qaseem A, Wilt TJ, McLean RM, Forceia MA; Clinical Guidelines Committee of the American College of Physicians. Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2017;166(7):514-530.
• Ramond A, Bouton C, Richard I, et al. Psychosocial risk factors for chronic low back pain in primary care--a systematic review. Fam Pract 2011;28(1):12-21.
• Nationale Versorgungsleitlinie Kreuzschmerz
  ÄZQ. Nationale VersorgungsLeitlinie Nicht-Spezifischer Kreuzschmerz, 2. Auflage Version 1. https://www.leitlinien.de/themen/kreuzschmerz/2-auflage. Published 2017.

Studies on the app (in progress or completed)

• Clement I., Lorenz A., Ulm B., Plidschun A. & Huber S. (2018). Implementing Systematically Collected User Feedback to Increase User Retention in a Mobile App for Self-Management of Low Back Pain: Retrospective Cohort Study. JMIR Rehabil Assist Technol, 4(2):e11. doi: 10.2196/rehab.9032.
• Huber S., Priebe J.A., Baumann K.-M., Plidschun A., Schiessl C & Tölle T. R. (2017) Treatment of Low Back Pain with a Digital Multidisciplinary Pain Treatment App: Short-Term Results. JMIR Rehabil Assist Technol;4(2):e11. doi: 10.2196/rehab.9032.
• Priebe J.A., Haas K.-K., Moreno Sanchez L. F. et al. (2020). Digital Treatment of Back Pain versus Standard of Care: The Cluster-Randomized Controlled Trial, RiseUp. Journal of Pain Research 13: 1823–1838. doi: 10.2147/JPR.S260761
• Priebe J. A., Utpadel-Fischer D.A. & Tölle T. R. (2020). Less Pain, Better Sleep? The Effect of a Multidisciplinary Back Pain App on Sleep Quality in Individuals Suffering from Back Pain - a Secondary Analysis of App User Data. Journal of Pain Research 13: 1121–1128. doi: 10.2147/JPR.S232792
• Tölle T. R., Utpadel-Fischer D.A., Hass K.-K., Priebe J. A. (2019). App-based multidisciplinary back pain treatment versus combined physiotherapy plus online education: a randomized controlled trial. npj Digital Medicine, 2(34). https://doi.org/10.1038/s41746-019-0109-x

The applicable Terms and Conditions and Privacy Policy can be found at www.kaiahealth.de.

The standards and profiles used for the interoperability of our medical device can be viewed on the simplifier.net/kaia website.