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

February 8, 2024 updated by: Gaia AG

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

276

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: TAU
Participants allocated to the control group will receive access to treatment as usual (TAU).
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.
Behavioral: relevis
Participants will receive access to the digital health intervention relevis in addition to TAU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Impairment
Time Frame: 3 months
Oswestry Low Back Pain Disability Questionnaire (ODI). Total score ranging from 0-100; higher scores mean higher functional impairment (worse outcome).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive Symptomatology
Time Frame: 3 months
Patient Health Questionnaire (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptomatology (worse outcome).
3 months
Work and Social Functioning
Time Frame: 3 months
Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher disability (worse outcome).
3 months
Intensity of Back Pain
Time Frame: 3 months
Numeric Rating Scale (NRS). Score ranging from 0-10; higher scores mean higher pain (worse outcome).
3 months
Health-related Quality of Life
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaia AG

Collaborators

University Hospital Schleswig-Holstein
Philipps Universität Marburg

Investigators

  • Principal Investigator: Kamila Jauch-Chara, MD, Universitätsklinikum Schleswig-Holstein, Campus Kiel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2024

Primary Completion (Estimated)

January 23, 2025

Study Completion (Estimated)

January 23, 2025

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • relevis RCT 2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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