Efficacy of app-based training on pain intensity and functionality in patients with intermediate and lower non-specific back pai
- Conditions
- M53Other dorsopathies, not elsewhere classified
- Registration Number
- DRKS00033412
- Lead Sponsor
- Zentrum für Integrierte Rehabilitation in den Universitäts- und Rehabilitationskliniken Ulm (RKU)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 135
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-.29: Spinal instability
• M53.86-.88(89): Other specified diseases of spine and back
• M53.96-.98(99): 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
• 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
• 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
• O00-O99: pregnancy, childbirth and puerperium
• 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Study duration per patient: 12 weeks: Pain intensity (NRS)
- Secondary Outcome Measures
Name Time Method Study duration per patient: 12 weeks: Oswestry Disability Index (ODI)