M54
Conditions
Interventions
Group 1: The intervention group receives access to the Alvie app for 12 weeks
Group 2: The control group receives the usual standard care in the form of physiotherapy
Sponsors
Anker Health GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Non-specific back pain (ICD code M54) (=4 on the Numeric Rating Scale), subacute or chronic - At least 18 years old - Access to a mobile device (smartphone etc.) - Availability of internet access for use as well as an active e-mail address - Ability to speak and read German - Willingness to use the app as intended and to participate in the other study-related measures - Ability to understand the nature and scope of the study and the training program - Ability to give written consent
Exclusion criteria
Exclusion criteria: - Patients with acute pain - Patients with a clear focus of pain in several areas of the spine - Use of pain medication that goes beyond a stable basic medication (stable for at least 3 weeks before the start of the study) and the defined rescue medication - Intake of muscle relaxants, high-dose magnesium or sleeping pills - Regular rubbing for the duration of the study and for 3 weeks prior to inclusion - Use of comparable digital therapies for the treatment of back pain for the duration of the study and for 3 weeks prior to inclusion - Use of physiotherapy for 3 weeks prior to inclusion - Prescription of manual therapy or massages for the duration of the study and for 3 weeks prior to inclusion - Prescription of other accompanying therapies such as stimulation current, cold and heat therapies for the duration of the study and for 3 weeks prior to inclusion - Inpatient and/or multimodal pain therapy within the last 12 months - Known pregnancy or postpartum - Current or planned inpatient stays or operations during the study period - Presence of red flags in the context of back pain - Known severe coronary heart disease and heart failure - Neurological disorders (sensation of tingling, numbness or weakness or presence of paralysis in the arms or legs, presence of sensory disturbances in the genital area, known sensorimotor disorders and dizziness, known neurological movement disorders, presence of known drug-induced perceptual disorders (in particular visual, hearing or balance disorders)). visual, hearing or balance disorders)) - Bone fracture or bone loss (presence of a known acute injury (trauma) due to a serious fall, car accident or sports accident, experience of a bone fracture after coughing, sneezing or heavy lifting (minor trauma), known pronounced bone loss (osteoporosis)) - Bone metastases or tumors (known bone metastases, currently undergoing chemotherapy, known weakness of the immune system) - Infections (currently suffering from fever, chills and rapid fatigue and loss of appetite) - Ongoing infiltration treatment - Known acute tissue infection (including skin and soft tissue infection) - Known joint diseases and infections (acute joint infection in the area of the spine, hip or knee joint or other joints, suffering from an acute infection of the tissue (including skin and soft tissue infections), severe or acute herniated disc) - Acute bleeding (suffering from acute blood loss, suffering from known pronounced anemia) - Respiratory tract (suffering from acute shortness of breath or breathing problems, known suffering from shortness of breath on exertion) - Vascular diseases (known suffering from a vascular disease, e.g. peripheral arterial occlusive disease, aneurysm, stenosis, known diagnosis of an existing thrombosis) - Mental illness (known suffering from a severe psychiatric illness, e.g. severe depression, schizophrenia, borderline personality disorder, bipolar disorder, schizotypal and delusional disorders, Alzheimer's disease, dementia, pronounced behavioral and social adjustment disorders, undergoing medical treatment for psychosis or schizoaffective disorder) - Known walking disabilities (incl. R29.6, R26.-, G82.-) - Kidney disease (presence of known renal insufficiency, dependence on dialysis) - Drug abuse (known psychoses and behavioral disorders caused by psychoactive substances) - Relative contraindications after consultation with the study physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in self-reported pain based on a Numeric Rating Scale (NRS) between T0 (baseline) and T2 (after 12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in self-reported functional ability using the Hannover Functional Ability Questionnaire (FFbH-R) between T0 (baseline) and T2 (after 12 weeks) Improvement in self-reported health-related quality of life using the Veterans RAND 12-Item Health Survey (VR-12) between T0 (baseline) and T2 (after 12 weeks) Therapy-related adherence based on the German version of the Exercise Adherence Rating Scale (G-EARS) at T2 (after 12 weeks) Improvement in self-reported health literacy using the short form of the European Health Literacy Survey Questionnaire (HLS19-Q12) between T0 (baseline) and T2 (after 12 weeks) Improvement in work ability based on the short form of the Work Ability Index (WAI) between T0 (baseline) and T2 (after 12 weeks) Acceptance of the patient app used based on the System Usability Scale (SUS) at T2 (after 12 weeks) Improvement in self-reported pain intensity using a Visual Analogue Scale (VAS) between T0 (baseline) and T2 (after 12 weeks) | — |
Countries
Germany
Outcome results
None listed