subacute non-specific low back pain chronic non-specific low back pain (M42.16, M42.17, M42.96, M42.97, M54.06, M54.07, M54.16, M54.17, M54.3, M54.4, M54.5, M54.86, M54.87, M54.96, M54.97, M99.03, M99.83, M99.93 )
Conditions
Interventions
Group 1: Standard therapy according to standard of care AND eCovery App
Group 2: Standard therapy according to standard of care
Sponsors
eCovery GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Persons of legal capacity = 18 years 2. Presence of non-specific low back pain (localized between the inferior costal arch and the gluteal fold according to ICD-10 coding) for which organic causes are not known OR In whom a correlation between organic disorder and current low back pain has been ruled out clinically or temporally by the investigator. 3. Duration of non-specific low back pain of >6 weeks 4. Presence of a written informed consent from the subject 5. Ability and willingness of the subject to comply with the requirements of the clinical trial 6. Access to the Internet and presence of a mobile device (e.g., smartphone, tablet, etc.) 7. Willingness and sufficient ability to use the eCovery app to be installed on one's mobile device regularly and as instructed during the duration of the examination 8. NRS = 4 on the day of randomization.
Exclusion criteria
Exclusion criteria: 1. Current participation in other interventional clinical trials 2. Use of another digital application to treat low back pain in the 6 months prior to randomization 3. Specific low back pain caused by o Herniated discs with radiculopathy or myelopathy (ICD-10 M50.- / M51.-). o Malpositions (scoliosis, ICD-10 M41.- or other deformities ICD-10 M43.-) o Spondylopathies (ICD-10 M45 - M49) o Trauma (ICD-10 S32.- / S33.-) o Neoplasms (ICD-10 C00 - D48) o Injuries of the spinal column ICD-10 T09.-), which have not been examined by a physician and to which the existing back pain could be attributable 4. Spinal surgeries within the last 12 months (ICD-10 Z98.-) or spinal surgeries planned during the study period 5. Part/section of the musculoskeletal system cannot be trained at home with physiotherapy 6. Not able to walk (in spite of forearm crutch, walking bench or rollator) 7. Not able to get down on the floor independently and also able to get up again on his/her own 8. Be cognitively unable to use the eCovery app, for example due to an existing guardianship ex officio or a medically proven reduction in intelligence according to WHO criteria (ICD-10 F70-79) and a comparable mental impairment. 9. Use of the eCovery app under the influence of alcohol and/or drugs. 10. Increased, unclear bleeding tendency (If hereditary clotting disorders are present, a doctor must decide whether it is safe to use the eCovery app before use). 11. Advanced heart disease (If heart disease is present, a doctor must decide whether it is safe to use the eCovery app before use). 12. Dizziness, frequent fall events, difficulty walking or standing. 13. Visual deficits and visual disturbances 14. Surgery on the knee or hip joint or back in the last 6 weeks (If surgery has been performed less than 6 weeks ago, a doctor must decide whether it is safe to use the eCovery app before use). 15. Osteoporosis (if osteoporosis is present, a doctor must decide whether it is safe to use the eCovery app before use). 16. Cancer that has not been clarified 17. Acute and chronic infections 18. Other uncontrolled or acute medical conditions at the time of screening that would jeopardize participation in the opinion of the investigator 19. Presence of other medical conditions that could interfere with the collection of study data, particularly efficacy and safety (at the investigator's discretion) 20. Pregnancy 21. Individuals who are in a dependent/employee relationship with the sponsor or investigator 22. Placement in an institution due to court or official order.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functionality (ODI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain (NRS) Medication use (arithmetic), Quality of life (VR-12), Compliance (arithmetic), Safety (incidence of AEs/SAEs). | — |
Countries
Germany
Outcome results
None listed