M54
Conditions
Interventions
Group 1: Treatment by kaia LBP app throughout the whole Trial period of 6 months, self-administered by patients on own mobile device, patients are encouraged to use app at least four times a week
Grou
Sponsors
Kaia Health Software GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Nonspecific low back pain with a mean pain intensity of = 4 on NRS for the last 6 weeks up to 12 months prior to inclusion. Participants were required to possess a proper command of the German language to be able to adequately answer the questionnaires.
Exclusion criteria
Exclusion criteria: Participants are excluded if they have had a past medical history of a malignancy, spinal surgery or any other known serious medical condition (e.g. uncontrolled Hypertension, congestive heart failure, movemement disorders, history of stroke, epilepsy, dementia, pregnancy, severe infectious diseases, bone disorders) or exhibited any clinical signs of a specific underlying cause (“red flags”).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A pain index is defined as the primary outcome and assessed on a 11-points numeric ratings scale (NRS; 0 = no pain, 10 = unbearable pain) for current pain, maximum and average pain over the last 4 weeks and mean pain over the last 4 weeks. Pain index is calculated as the mean of current, maximum and average pain intensity and assessed at enrollment, as well as at 6-, 12- and 24-week follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary outcomes functional capability (using HFAQ), Health-related quality of life (using VR-12), Graded Chronic Pain Scale (GCPS) and pain self-efficacy (pain self-efficacy questionnaire) are assessed at enrollment, as well as at 6-, 12- and 24-week follow-up. | — |
Countries
Germany
Contacts
Public ContactDaniel Utpadel-Fischler
Technische Universität München, Klinikum rechts der Isar
Outcome results
None listed