Digital health application for managing back pain
Effectiveness of a Digital Health Application for Subacute and Chronic Back Pain (Relevis): a Randomized Controlled Trial
This study is testing a new app called Relevis to see if it can help adults with ongoing back pain manage their symptoms and improve their daily activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 276 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gaia AG Industry-sponsored |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT06221956 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of the unguided digital therapeutic application, Relevis, for patients suffering from subacute or chronic back pain. It involves 276 participants aged 18 and older who have been diagnosed with specific types of back pain and have impaired functional ability. Participants will use the Relevis application to manage their condition, and their progress will be monitored throughout the trial. The study aims to determine if this digital intervention can improve pain management and functional outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with subacute or chronic back pain and impaired functional ability.
Not a fit: Patients who have recently changed their treatment for back pain or have specific underlying causes for their pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this application could provide a convenient and effective tool for patients to manage their back pain and improve their quality of life.
How similar studies have performed: Other studies have shown promise in using digital therapeutics for pain management, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 * Presence of subacute (6-12 weeks) or chronic (\>12 weeks) back pain * Submission of a medical certificate attesting to the presence of at least one of the following ICD-10-GM diagnoses of back pain: * M47.8x - Spondylosis * M47.9x - Other spondylosis * M54.5 - Back pain * M54.8x - Other back pain * M54.9x - Unspecified back pain * M51.0x - Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with myelopathy * M51.1x - Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy * M51.2 - Other thoracic, thoracolumbar and lumbosacral intervertebral disc displacement * Impaired functional ability (ODI ≥ 21) * Consent to participate * Sufficient knowledge of the German language Exclusion Criteria: * Change in treatment of back pain in the past month * Planned change in treatment of back pain in the next 3 months * Prior use of other online programs/apps for back pain * History of back, knee or hip surgery in the past 6 months * History of more than one back surgery during lifetime * Presence of a specific cause for back pain, e.g.: * Fracture * Infection * Neuropathies (except when due to disc prolapse) * Axial spondyloarthritis * Tumor or metastases * Cauda equina syndrome * Acute myocardial infarction * Unstable coronary heart disease/angina pectoris or heart failure * Acute thrombosis * Manifest osteoporosis * Acute fevers * Rheumatic autoimmune diseases
Where this trial is running
Hamburg
- Gaia Ag — Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Kamila Jauch-Chara, MD — University Hospital Schleswig-Holstein
- Study coordinator: Gitta A. Jacob, PhD
- Email: gitta.jacob@gaia-group.com
- Phone: +49.40.349930-374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.