Effectiveness of a Digital Health Application for Subacute and Chronic Back Pain (Relevis): a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
GAIA AG
RECRUITING
Hamburg
Contact Information
Primary
Gitta A. Jacob, PhD
gitta.jacob@gaia-group.com
+49.40.349930-374
Backup
Antje Riepenhausen, PhD
antje.riepenhausen@gaia-group.com
Time Frame
Start Date: 2024-01-23
Estimated Completion Date: 2025-01-23
Participants
Target number of participants: 276
Treatments
Experimental: relevis + TAU
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.
No_intervention: TAU
Participants allocated to the control group will receive access to treatment as usual (TAU).
Sponsors
Collaborators: Philipps Universität Marburg, University Hospital Schleswig-Holstein
Leads: Gaia AG

This content was sourced from clinicaltrials.gov