Clinical trial NCT06221956: Effectiveness of a Digital Health Application for Subacute and Chronic Back Pain (Relevis)
Official title: Effectiveness of a Digital Health Application for Subacute and Chronic Back Pain (Relevis): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Back Pain
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Schleswig-Holstein
name: Philipps Universität Marburg
First posted: 2024-01-24
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Functional Impairment
timeFrame: 3 months
Secondary outcomes:
measure: Depressive Symptomatology
timeFrame: 3 months
measure: Work and Social Functioning
timeFrame: 3 months
measure: Intensity of Back Pain
timeFrame: 3 months
measure: Health-related Quality of Life
timeFrame: 3 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: GAIA AG
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Kamila Jauch-Chara, MD
role: PRINCIPAL_INVESTIGATOR
References: