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NCT06221956: APRICOT
Effectiveness of a Digital Health Application for Subacute and Chronic Back Pain (Relevis)
NA trial testing relevis in Back Pain in 276 participants. Status unknown.
23 January 2025
Quick facts
| Lead sponsor | Gaia AG |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 276 |
| Start date | 23 January 2024 |
| Primary completion | 23 January 2025 |
| Estimated completion | 23 January 2025 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- relevis
Conditions studied
- Back Pain — all drugs for Back Pain →
Sponsor
Gaia AG — full company profile →
Who can join
18 and older, any sex, with Back Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical trial with 276 patients with subacute or chronic back pain aims to investigate the effectiveness of the unguided digital therapeutic relevis for patients with subacute or chronic back pain. Inclusion criteria are: age ≥ 18 years, presence of subacute (6-12 weeks) or chronic (\>12 weeks) back pain, attested by a medical certificate (relevant ICD-10-GM diagnoses: M47.8x, M47.9x, M54.5, M54.8x, M54.9x, M51.0x, M51.1x, M51.2), impaired functional ability \[Oswestry Disability Index (ODI) ≥ 21\], consent to participation, sufficient knowledge of the German language. Exclusion criteria are: 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, hip or knee surgery in the past 6 months, history of more than one back surgery in 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. Patients will be randomized and allocated to either an intervention group in a 1:1 ratio, in which they will receive access to relevis in addition to treatment as usual (TAU, n = 138), or to a control group, in which they will receive only TAU (n = 138). TAU is defined as any therapy prescribed or recommended by the GP or specialists (e. g. orthopedic surgeon, rheumatologists etc.) which may include physiotherapy, injections in the spine, drug therapy, orthesis, etc. (1,2). The primary endpoint will be the functional impairment, measured by the ODI, with three months post-allocation being the primary time point for assessment of effectiveness (T1). Six months post-allocation (T2) will be used as the follow-up assessment endpoint. Secondary endpoints will be depression, work and social functioning, pain intensity, and health-related quality of life.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06221956
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06655337 — Efficiency of the "Medidux" Smartphone App for Demission Management in Patients Medicated in Acute Admission Unit (AAU) · NA · recruiting
- NCT07104227 — Effects of Body Mechanics Training on Shoulder-Back Pain and Breastfeeding Ergonomics in Breastfeeding Mothers · NA · active not recruiting
Other Gaia AG trials
Trials by the same sponsor.
- NCT06529965 — Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With T2DM · NA · recruiting
- NCT06601907 — Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder · NA · terminated
- NCT06237166 — Evaluation of an Online Intervention for Female Sexual Dysfunction · NA · completed
- NCT06243978 — Effectiveness of a Digital Health Application for Primary Hypertension (Liebria) · NA · recruiting
- NCT06221930 — Researching the Effectiveness of Attexis, a Digital Health Application for Adults With Attention Deficit Hyperactivity D · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06221956 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gaia AG
- Last refreshed: 9 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06221956.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing