M53.24-.28, M53.3, M53.84-.88, M53.94-.98, M54.5, M54.6, M54.84-.88, M54.94-.98, M99.02 - M99.04, M99.82 - M99.84, M99.92 - M99.94
Conditions
Interventions
Group 1: Patients receive access to Novio Back for 12 weeks. Novio Back supports the independent execution of movement and relaxation exercises and includes various educational content. Novio back is
Sponsors
Zentrum für Integrierte Rehabilitation in den Universitäts- und Rehabilitationskliniken Ulm (RKU)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diagnosis of non-specific back pain in one of the following indications: Mid Back: • M53.24-.25: Spinal instability • M53.84-.85: Other specified diseases of spine and back • M53.94-.95: Disorders of spine and back, unspecified • M54.6: Pain in thoracic spine • M54.84-.85: Other low back pain • M54.94-.95: Back pain, unspecified • M99.02: Segmental and somatic fun • M99.82: Other biomechanical disorders • M99.92: Biomechanical dysfunction, unspecified Lower back: • M53.26-.28: Spinal instability • M53.86-.88: Other specified diseases of spine and back • M53.96-.98: Unspecified diseases of spine and back • M53.3: Diseases of sacrocolygeal reaction, not elsewhere classified • M54.5: Low back pain • M54.86 - M54.88: Other back pain • M54.96 - M54.98: Back pain, unspecified • M99.03 - M99.04: Segmental and somatic dysfunction • M99.83 - M99.84: Other biomechanical disorders • M99.93 - M99.94: Biomechanical dysfunction, unspecified • Age >= 18 years • Pain duration of > 3 weeks with confinement • Pain intensity (NRS) = 4 • Sufficient knowledge of German • Possession of an app-enabled smartphone that meets the app's compatibility commitments • Willingness to use the app regularly • Willingness to participate in surveys and ward rounds • E-mail address for registration • Internet access for smartphones
Exclusion criteria
Exclusion criteria: • Age: < 18 • Contraindications of the medical device • No app-enabled smartphone • No pain, pain intensity < 4 • Previous exercise therapy with a comparable digital health application • Participation in other comparable training or exercise therapies for non-specific back pain (e.g., functional training or rehabilitation sports) in the preceding 3 weeks or ongoing participation/ planned participation in multimodal therapy within 12 weeks after inclusion • Ongoing use of other non-drug adjunctive therapies for nonspecific back pain, such as acupuncture • Insufficient language skills • No active exercise possible • Inability/unwillingness to adhere to training • Neurological disease that does not allow participation in the study (e.g. dementia, Alzheimer's disease, etc.) • Serious mental illness that does not allow participation in the study • Autoimmune diseases that do not allow participation in the study • Rheumatic diseases of the spine • Surgery on the spine in the past or planned in the next 12 weeks • Lumboischialgia with clinical radiculopathy (M54.4) Contraindications of the medical device • T08: Fracture of spine, height not further described • T09: Other injuries of spine and trunk, height not further described • M51.0, M51.1, M51.2, M51.8 + M51.9: Intervertebral disc damage (with radicular symptoms) • M43.0: Spondylolysis or M43.1: Spondylolisthesis • M48.0: Spinal stenosis • M81: Diagnosed osteoporosis • M13: Other arthritis • M62.08: Diastasis recti • B99: febrile infection • M46: Spinal infection • D33.4: benign neoplasm of spinal cord • C41.2: Malignant neoplasm of bone and articular cartilage: spine • C79.5: Secondary malignant neoplasm of bone and bone marrow • Z98: Other conditions after surgery • Q76: Congenital malformations of spine and bony thorax • I10, I50; I51: uncontrolled hypertension, advanced heart disease • G82: Disorders that reduce leg control • M25: Diseases of joints of legs • G82: Paraplegia and quadriplegia • G40: Epilepsy • H54.0, H54.1, H54.4, H54.5: Blindness and visual impairment Relative contraindications of the medical device • O00-O99: Pregnancy, childbirth, and the postpartum period • M54.4: Lumboischialgia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study duration per patient: 12 weeks: Pain intensity (NRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Study duration per patient: 12 weeks: Oswestry Disability Index (ODI) | — |
Countries
Germany
Contacts
Public ContactPatricia Lang
Zentrum für Integrierte Rehabilitation in den Universitäts- und Rehabilitationskliniken Ulm (RKU)
Outcome results
None listed