NCT03798288

Brief Summary

The intervention consists of a digital decision support system delivering a weekly plan of suggested activities that the participant can use to self-manage their low back pain (LBP) via an smartphone app.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
461

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable low-back-pain

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 8, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2020

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

1.2 years

First QC Date

January 7, 2019

Last Update Submit

February 14, 2023

Conditions

Low Back Pain

Keywords

Digital Decision Support SystemAppSelf-management

Outcome Measures

Primary Outcomes (1)

  • Roland Morris Disability Questionnaire

    The primary outcome is the Roland Morris Disability Questionnaire (RMDQ) assessing pain-related disability. The questionnaire includes 24 items asking participants to indicate if they experience functional impairments by answering "yes" or "no" to a series of descriptions of functional abilities with higher scores indicating higher level of disability.

    change from baseline to 3 months

Secondary Outcomes (6)

  • Pain Self-Efficacy Questionnaire

    change from baseline to 3 months

  • The Fear Avoidance Belief Questionnaire

    change from baseline to 3 months

  • Pain intensity

    change from baseline to 3 months

  • Brief Illness Perception Questionnaire

    change from baseline to 3 months

  • Saltin-Grimby Physical Activity Level Scale

    change from baseline to 3 months

  • +1 more secondary outcomes

Other Outcomes (13)

  • Workability

    change from baseline to 3 months

  • Health-related Quality of Life

    change from baseline to 3 months

  • Activity limitation

    change from baseline to 3 months

  • +10 more other outcomes

Study Arms (2)

Usual care + selfBACK

EXPERIMENTAL

The selfBACK system constitutes a data-driven decision support system that uses case-based reasoning to capture and reuse participant cases to suggest the most suitable self-management plan for participants. The system is an intelligent system delivering self-management plans tailored to individual participant characteristics. Information about participant characteristics is collected via a (baseline) questionnaire, weekly self-reports via the app on symptom progression etc., and a wristband that detect daily number of steps. The weekly plans are presented in an app to participants. The weekly plan includes three categories of content; 1. information/education 2. recommended daily number of steps 3. recommended strength and flexibility exercises

Behavioral: selfBACKOther: Usual care

Usual care

ACTIVE COMPARATOR

Any diagnostic or treatment-related pathway (e.g. receive information, advice or treatment) as instructed by their health care professional. Patients are allowed to seek care, treatment or help elsewhere as normal.

Other: Usual care

Interventions

selfBACKBEHAVIORAL

Participants will use the selfBACK system and app in addition to receiving usual care

Usual care + selfBACK
Usual careOTHER

Participants will receive usual care

Usual careUsual care + selfBACK

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Seeking care from primary health-care practice (general practitioners, physiotherapists, chiropractors) or a local outpatient spinecenter (DK) for non-specific LBP within the past 8 weeks
  • LBP of any duration
  • Mild-to severe pain-related disability rated as 6 or above on the Roland Morris Disability Questionnaire
  • Age: ≥18 years
  • Own and regularly use a smart phone (with at least Android 7.0 or iOS11.0) with internet access (Wi-Fi and/or mobile data)
  • Have a working email address and have access to a computer with internet access to complete questionnaires in a web browser.

You may not qualify if:

  • Not interested,
  • Unable to speak, read or understand the national language (Danish/ Norwegian),
  • Cognitive impairments or learning disabilities limiting participation,
  • Mental or physical illness or condition limiting participation,
  • Inability to take part in exercise/physical activity,
  • Fibromyalgia (diagnosed by a health care professional),
  • Pregnancy,
  • Previous back surgery
  • Ongoing participation in other research trials for LBP management.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Physical Activity and Health at Work, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark

Odense, 5230, Denmark

Location

Norwegian University of Science and Technology

Trondheim, Norway

Location

Related Publications (8)

  • Mork PJ, Bach K; selfBACK Consortium. A Decision Support System to Enhance Self-Management of Low Back Pain: Protocol for the selfBACK Project. JMIR Res Protoc. 2018 Jul 20;7(7):e167. doi: 10.2196/resprot.9379.

    PMID: 30030208BACKGROUND

  • Kongstad LP, Overas CK, Skovsgaard CV, Sandal LF, Hartvigsen J, Sogaard K, Mork PJ, Stochkendahl MJ. Cost-effectiveness analysis of app-delivered self-management support (selfBACK) in addition to usual care for people with low back pain in Denmark. BMJ Open. 2024 Sep 5;14(9):e086800. doi: 10.1136/bmjopen-2024-086800.

    PMID: 39242164DERIVED

  • Bardal EM, Sandal LF, Nilsen TIL, Nicholl BI, Mork PJ, Sogaard K. Do age, gender, and education modify the effectiveness of app-delivered and tailored self-management support among adults with low back pain?-Secondary analysis of the selfBACK randomised controlled trial. PLOS Digit Health. 2023 Sep 22;2(9):e0000302. doi: 10.1371/journal.pdig.0000302. eCollection 2023 Sep.

    PMID: 37738237DERIVED

  • Svendsen MJ, Nicholl BI, Mair FS, Wood K, Rasmussen CDN, Stochkendahl MJ. One size does not fit all: Participants' experiences of the selfBACK app to support self-management of low back pain-a qualitative interview study. Chiropr Man Therap. 2022 Oct 3;30(1):41. doi: 10.1186/s12998-022-00452-2.

    PMID: 36192724DERIVED

  • Overas CK, Nilsen TIL, Nicholl BI, Rughani G, Wood K, Sogaard K, Mair FS, Hartvigsen J. Multimorbidity and co-occurring musculoskeletal pain do not modify the effect of the SELFBACK app on low back pain-related disability. BMC Med. 2022 Feb 8;20(1):53. doi: 10.1186/s12916-022-02237-z.

    PMID: 35130898DERIVED

  • Sandal LF, Bach K, Overas CK, Svendsen MJ, Dalager T, Stejnicher Drongstrup Jensen J, Kongsvold A, Nordstoga AL, Bardal EM, Ashikhmin I, Wood K, Rasmussen CDN, Stochkendahl MJ, Nicholl BI, Wiratunga N, Cooper K, Hartvigsen J, Kjaer P, Sjogaard G, Nilsen TIL, Mair FS, Sogaard K, Mork PJ. Effectiveness of App-Delivered, Tailored Self-management Support for Adults With Lower Back Pain-Related Disability: A selfBACK Randomized Clinical Trial. JAMA Intern Med. 2021 Oct 1;181(10):1288-1296. doi: 10.1001/jamainternmed.2021.4097.

    PMID: 34338710DERIVED

  • Rasmussen CDN, Svendsen MJ, Wood K, Nicholl BI, Mair FS, Sandal LF, Mork PJ, Sogaard K, Bach K, Stochkendahl MJ. App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation. JMIR Res Protoc. 2020 Oct 29;9(10):e20308. doi: 10.2196/20308.

    PMID: 33118959DERIVED

  • Sandal LF, Stochkendahl MJ, Svendsen MJ, Wood K, Overas CK, Nordstoga AL, Villumsen M, Rasmussen CDN, Nicholl B, Cooper K, Kjaer P, Mair FS, Sjogaard G, Nilsen TIL, Hartvigsen J, Bach K, Mork PJ, Sogaard K. An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 3;8(12):e14720. doi: 10.2196/14720.

    PMID: 31793897DERIVED

Related Links

MeSH Terms

Conditions

Low Back PainAlzheimer Disease

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Karen Søgaard, PhD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The analysis of the data will be performed blindly.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study design is a multi-center randomised controlled trial with 2 parallel arms
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 9, 2019

Study Start

March 8, 2019

Primary Completion

May 6, 2020

Study Completion

October 20, 2020

Last Updated

February 17, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)NO(1)