e-Health and mobile health application for the self-management support of patients with low back pain - a confirmatory trial
Not Applicable
- Conditions
- DorsalgiaM54
- Registration Number
- DRKS00016329
- Lead Sponsor
- Kaia Health Software GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 101
Inclusion Criteria
Nonspecific low back pain with a mean pain intensity of = 4 on NRS for the last 6 weeks up to 12 months prior to inclusion. Participants were required to possess a proper command of the German language to be able to adequately answer the questionnaires.
Exclusion Criteria
Participants are excluded if they have had a past medical history of a malignancy, spinal surgery or any other known serious medical condition (e.g. uncontrolled Hypertension, congestive heart failure, movemement disorders, history of stroke, epilepsy, dementia, pregnancy, severe infectious diseases, bone disorders) or exhibited any clinical signs of a specific underlying cause (red flags”).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A pain index is defined as the primary outcome and assessed on a 11-points numeric ratings scale (NRS; 0 = no pain, 10 = unbearable pain) for current pain, maximum and average pain over the last 4 weeks and mean pain over the last 4 weeks. Pain index is calculated as the mean of current, maximum and average pain intensity and assessed at enrollment, as well as at 6-, 12- and 24-week follow-up.
- Secondary Outcome Measures
Name Time Method As secondary outcomes functional capability (using HFAQ), Health-related quality of life (using VR-12), Graded Chronic Pain Scale (GCPS) and pain self-efficacy (pain self-efficacy questionnaire) are assessed at enrollment, as well as at 6-, 12- and 24-week follow-up.