Effectiveness of a Digital Health Application for Subacute and Chronic Back Pain (Relevis)

Back Pain Clinical Trial

— APRICOT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06221956
• Other study ID #: relevis RCT 2024
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2024
• Est. completion date: January 23, 2025

Study information

• Verified date: February 2024
• Source: Gaia AG
• Contact: Gitta A. Jacob, PhD
• Phone: +49.40.349930-374
• Email: gitta.jacob[@]gaia-group.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 276
• Est. completion date: January 23, 2025
• Est. primary completion date: January 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain

Intervention

Behavioral:
• relevis
Participants will receive access to the digital health intervention relevis in addition to TAU.

Locations

Country	Name	City	State
Germany	GAIA AG	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Gaia AG	Philipps Universität Marburg, University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Impairment	Oswestry Low Back Pain Disability Questionnaire (ODI). Total score ranging from 0-100; higher scores mean higher functional impairment (worse outcome).	3 months
Secondary	Depressive Symptomatology	Patient Health Questionnaire (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptomatology (worse outcome).	3 months
Secondary	Work and Social Functioning	Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher disability (worse outcome).	3 months
Secondary	Intensity of Back Pain	Numeric Rating Scale (NRS). Score ranging from 0-10; higher scores mean higher pain (worse outcome).	3 months
Secondary	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).	3 months