An interventional study of relevis in Back Pain, sponsored by Gaia AG. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Gaia AG · Not applicable, Interventional, and Treatment
Among 28 studies in Back Pain with a site in Germany — 5 open to participants now, 5 under way, 2 of them phase 3. Back Pain · Germany.
Among the 28 studies in Back Pain with a site in Germany, this one is the 9th largest by planned enrollment of the 25 interventional ones that give a count, is the only one that started in 2024, is one of 13 with no phase, and was the 28th registered.
728 studies on the registry are indexed under Back Pain; 109 are open to participants now.
This study's planned enrollment of 276 is above the median of 70 across 593 interventional studies indexed under Back Pain.
Browse Back Pain studies →5 of the 28 studies in Back Pain with a site in Germany are open now, in 12 countries. Each count lists the studies.
Of the 68 Back Pain studies recruiting now, 29 (43%) set no upper age limit and 32 (47%) stop at 75 or younger; 3 take children under 18; 11 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →28 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2024.
Median enrollment 165 across the 25 interventional studies, 4,800 across the 3 observational. Of the 19 that completed or were terminated, 10 (53%) have results posted.
19 of 28 have an industry lead sponsor. The 10 most frequent:
Gaia AG is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Gaia AG has 1 study filed under Back Pain — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 28 studies in Back Pain with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Submission of a medical certificate attesting to the presence of at least one of the following ICD-10-GM diagnoses of back pain:
Exclusion Criteria:
Presence of a specific cause for back pain, e.g.:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants allocated to the intervention group will receive access to relevis in addition to treatment as usual (TAU). relevis is a digital health application designed for individuals with subacute or chronic back pain, accessible through a web browser. The application consists of six physical exercise modules that cover four exercises with thiree different levels of difficulty, each, and ten interactive "conversations" on different topics (changes in the body, pain development and processing, chronic pain, pain and mood, relaxation and mindfulness, becoming active against pain, stress and pain, nutrition and pain, sleep and pain, work and pain). "Conversations" are accompanied by illsutrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days.
Behavioral: relevis
Participants allocated to the control group will receive access to treatment as usual (TAU).
Participants will receive access to the digital health intervention relevis in addition to TAU.
Functional Impairment
Oswestry Low Back Pain Disability Questionnaire (ODI). Total score ranging from 0-100; higher scores mean higher functional impairment (worse outcome).
Time frame: 3 months
Depressive Symptomatology
Patient Health Questionnaire (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptomatology (worse outcome).
Time frame: 3 months
Work and Social Functioning
Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher disability (worse outcome).
Time frame: 3 months
Intensity of Back Pain
Numeric Rating Scale (NRS). Score ranging from 0-10; higher scores mean higher pain (worse outcome).
Time frame: 3 months
Health-related Quality of Life
Assessment of Quality of Life - 8 Dimensions (AQoL-8D). Total score ranging from 0-100; higher scores mean higher quality of life (better outcome).
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Jan 2025, 12 months after the start.
Of 35 industry-sponsored interventional studies with no phase under Back Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 46. This study's planned 12 months is below that.
Counting every sponsor, half of 294 studies reached it within 13 months; a quarter within 5 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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