M53.0 M53.1
Conditions
Interventions
Group 1: Intervention group: Smartphone app ViViRA Neck with access for 12 weeks
Group 2: Control group: Standard of care, i.e., at least 1 prescription with 6 sessions of individual physical therapy
Sponsors
Vivira Health Lab GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Diagnosis of NSNP (ICD-10 Codes: M53.0 - Cervicocranial Syndrome; M53.1 - Cervicobrachial Syndrome) - Presence of pain for at least 4 weeks - Screening VAS pain score of 40/100 or more - In possession of and familiar with the use of a smartphone or tablet running the following operating systems: Android 8.0 or higher, or iOS 15.0 or higher, and having internet access - Existence of a personal email account - Provision of informed consent, i.e., participant must be able to understand and sign the Patient Information and the Consent Form - Patients who are able and willing to follow the exercise protocol
Exclusion criteria
Exclusion criteria: - Ongoing or prior (within past 4 weeks) physiotherapy for neck pain - Ongoing or prior use (within past 4 weeks) of digital and non-digital exercise therapy - Ongoing or prior use (within past 4 weeks) of other non-medication therapies due to neck pain - Use of prescription analgesics ongoing or prior to inclusion (within past 4 weeks) - Severe medical comorbidities (see section 6.3 for details) - Active malignant diseases or a diagnosis of such within the past 5 years - Infectious diseases of the bone, joints, or spine within the past 5 years that could limit the ability to complete unsupervised exercise therapy - Systemic rheumatologic condition or non-infectious inflammations within the past 5 years - Clotting or bleeding disorders - Bone/joint fractures (within the last 3 months or without clearance from a qualified healthcare professional) - Surgical interventions (within the last 3 months or without clearance from a qualified healthcare professional) - Pain (including neck pain) resulting from a fall or accident that has not been assessed by a qualified healthcare professional - Acute or chronic complaints due to persistent and structural musculoskeletal disorders - Shoulder, knee and/or hip replacement - Spinal disc pathologies with radiculopathy (affecting all areas of the spine) within the previous 5 years - Severe neurological comorbidities - Posture insecurity and/or vertigo - Psychiatric comorbidity (severe or uncontrolled) - Neurocognitive impairment - Addiction disorder - Self-reported pregnancy or intention to become pregnant - Current or past (previous 30 days) participation in another clinical trial, except for enrollment and participation in the specified research panel, “www.mein-ruecken-und-ich.de” at the Orthopedic University Hospital of the Ruhr University Bochum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity: Visual Analogue Scale (VAS, 0-100) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Disability: Neck Disability Index (NDI) - Quality of life: Veterans Rand 12-item health survey (VR12) | — |
Countries
Germany
Contacts
Public ContactTobias Schulte
Klinik für Orthopädie und Unfallchirurgie, Orthopädische Universitätsklinik der Ruhr-Universität Bochum, Katholisches Klinikum Bochum
Outcome results
None listed