Chronic non-specific upper back pain
Conditions
Interventions
Group 1: eCovery therapy app
Group 2: standard therapy
Sponsors
eCovery GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adults with legal capacity (= 18 years) 2. Presence of non-specific upper back pain (bounded superiorly by the superior nuchal line [linea nuchalis superior], inferiorly by the costal arch, and laterally by the insertions of the trapezius muscle [M. trapezius] near the shoulder joint), for which no organic causes are known, OR for which a clinical or temporal correlation between an organic disorder and the current back pain has been ruled out by the investigator 3. Duration of non-specific upper back pain of > 12 weeks 4. NRS = 4 on the day of randomization 5. NDI = 10 on the day of randomization 6. Ability of the trial participant to reliably understand, read, and speak German 7. At the time of randomization, the trial participant has secured access to physiotherapeutic care and the possibility to start training with the eCovery Therapy App within 48 hours. In the event of allocation to the control group, it must be ensured that physiotherapeutic contact can take place within 48 hours after randomization. The respective assessment is made by the investigator. 8. The trial participant has the capacity to consent, meaning the ability to understand the nature, significance, and implications of the clinical trial, to independently evaluate the information received, and to make a voluntary decision regarding participation in the study. 9. Written informed consent from the trial participant is available. 10. Ability and willingness of the trial participant to comply with the requirements of the clinical trial 11. Access to the internet and possession of their own mobile device (smartphone, tablet) 12. Willingness and sufficient ability to regularly and properly use the eCovery Therapy App to be installed on their own mobile device during the trial period
Exclusion criteria
Exclusion criteria: 1. Current participation or participation within the last 4 weeks prior to screening in another clinical trial 2. Use of the eCovery Therapy App for the treatment of back pain within the last 4 weeks prior to screening 3. Use of the eCovery Therapy App for the treatment of back pain in the control group until completion of the clinical trial 4. Use of an additional digital application (e.g. therapy apps) for the treatment of back pain from the last 4 weeks prior to screening until completion of the clinical trial 5. Use of an additional therapy/private service (e.g. manual therapy, yoga) for the treatment of back pain from the last 4 weeks prior to screening until completion of the clinical trial 6. Specific upper back pain caused by: * Herniated discs with radiculopathy or myelopathy (ICD-10 M50.-/M51.-) * Postural deformities (scoliosis, ICD-10 M40.-/M41.-, or other deformities, ICD-10 M43.-) * Spondylopathies (ICD-10 M45–M49) * Trauma (ICD-10 S12.- / S13.- / S14.-) * Neoplasms (ICD-10 C00–D48) * Spinal injuries (ICD-10 T09.-) that have not been medically assessed and to which the existing back pain could be attributable 7. Medication not permitted during the clinical trial: * Any medication containing an active substance from the opioid class * Any muscle relaxant medication * Trial participants for whom opioid therapy is currently clinically indicated, or is expected to become indicated during the study period, according to medical assessment and taking into account the applicable specialist guidelines 8. Surgery of the spine within the last 12 months prior to randomization (e.g. documented by ICD-10-GM code Z98.- “Other postprocedural states” in combination with corresponding OPS codes), as well as planned surgical interventions on the spine during the clinical trial 9. Spinal disorders (M51.0, M51.1) with numbness or weakness in the legs 10. Surgery of the knee or hip joint or back within the last 6 weeks, or at the discretion of the investigator 11. Presence of other medical conditions that could interfere with the collection of study data, particularly efficacy and safety data, at the discretion of the investigator 12. Persons who are in a dependent/employment relationship with the sponsor or investigator 13. Acute infections and chronic infections (R50, R53, J06.9, A49, B34.9), fever with malaise and fatigue at the time of screening, which, at the discretion of the investigator, make it impossible to perform the exercises 5 times per week for 20–30 minutes each 14. Chronic diseases such as heart failure, cardiovascular diseases, COPD, asthma, or other chronic diseases at the time of screening which, at the discretion of the investigator, make it impossible to perform the exercises 5 times per week for 20–30 minutes each 15. Autoimmune diseases characterized by acute flare-ups, e.g. rheumatism and psoriasis, or other acute diseases with malaise, fever, and fatigue at the time of screening which, at the discretion of the investigator, make it impossible to perform the exercises 5 times per week for 20–30 minutes each 16. Other uncontrolled acute or chronic diseases with malaise, fever, and fatigue at the time of screening which, at the discretion of the investigator, make it impossible to perform the exercises 5 times per week for 20–30 minutes each 17. The affected body region cannot be exercised physiotherapeutically at home 18. Inability to walk, even with forearm crutches,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain reduction from Week 1 to Week 13 (Numeric Rating Scale; NRS) Functional improvement from Week 1 to Week 13 (Neck Disability Index; NDI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Interim pain reduction Interim functional improvement Risk of chronicity Adherence Safety parameters (product safety) | — |
Countries
Germany
Contacts
Public ContactKlara Spieß
eCovery GmbH
Outcome results
None listed