NCT03697759

Brief Summary

The pilot study precedes a larger randomized controlled trial, to be starting in February 2019. In this pilot study all participants are allocated to the intervention group. 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. The plan is presented to the participant in the selfBACK app.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Aug 2018

Shorter than P25 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

August 10, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

August 20, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2019

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2019

Completed
Last Updated

February 28, 2019

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

August 10, 2018

Last Update Submit

February 27, 2019

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 6 weeks

Secondary Outcomes (16)

  • Pain intensity

    change from baseline to 6 weeks

  • The Fear avoidance Belief Questionnaire

    change from baseline to 6 weeks

  • Pain Self-Efficacy Questionnaire

    change from baseline to 6 weeks

  • Activity limitation

    change from baseline to 6 weeks

  • Workability

    change from baseline to 6 weeks

  • +11 more secondary outcomes

Other Outcomes (3)

  • Tailoring variables

    Weekly for 6 weeks

  • Physical activity

    weekly for 6 weeks

  • Exercise volume

    weekly for 6 weeks

Study Arms (1)

Usual care + selfBACK

EXPERIMENTAL

Participants will use the selfBACK system and app

Other: Usual care + selfBACK

Interventions

Usual care + selfBACKOTHER

The selfBACK intervention is a digital Decision Support System (DSS) for self-management of LBP provided to the participant via a smartphone app (selfBACK app). In addition, the participant is provided with a step-detecting wristband (Xiaomi Mi Band 2) that interacts with the selfBACK app. The DSS provides individually tailored self-management plans including content from three categories; 1) information/education, 2) physical activity monitoring through wearing the step-detecting wristband, and 3) strength and flexibility exercises. The weekly plans are individually tailored to the specific patient, using the data available from the patient, and each week the patients report back their progress on physical activity (step count) and exercise (volume completed). These data are matched with the patients follow-up data to create a self-management plan that is up to date and adaptable to variation in health-status of the individual patient.

Also known as: selfBACK digital decision support system
Usual 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 or a specialised outpatient hospital facility (DK) for non-specific LBP within the past 8 weeks
  • LBP of any duration
  • Mild-to severe pain-related disability rated as 16 or below on the PROMIS-PF4 function scale.
  • 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 write in the national language (Danish/ Norwegian)
  • Cognitive impairment or learning disabilities
  • Pathology, such as fracture, cancer, inflammatory diseases, and signs of radiculopathy (severe leg pain, loss of leg strength, or loss of or altered sensation in a myotomal or dermatomal distribution)
  • Serious mental illness, such as major depression, schizophrenia, and psychosis
  • Terminal illness
  • Unable to take part in exercise/physical activity (such as non-ambulatory patients, use of walking aids/assistance, unable to get down and up from the floor independently)
  • 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 Techonology

Trondheim, Norway

Location

Related Publications (2)

  • Bach K, Szczepanski T, Aamodt A, Gundersen OE, Mork. PJ. Case Representation and Similarity Assessment in the selfBACK Decision Support System ICCBR 2016: Case-Based Reasoning Research and Development pp 32-46

    BACKGROUND

  • Sandal LF, Overas CK, Nordstoga AL, Wood K, Bach K, Hartvigsen J, Sogaard K, Mork PJ. A digital decision support system (selfBACK) for improved self-management of low back pain: a pilot study with 6-week follow-up. Pilot Feasibility Stud. 2020 May 23;6:72. doi: 10.1186/s40814-020-00604-2. eCollection 2020.

    PMID: 32489674DERIVED

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
NA
Masking
NONE
Masking Details
Since there is no randomization, all participants receive the intervention. Consequently, there is no blinding.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study is a pilot study preceding a randomized controlled trial. In the pilot study all enrolled participants are offered the intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2018

First Posted

October 5, 2018

Study Start

August 20, 2018

Primary Completion

February 5, 2019

Study Completion

February 17, 2019

Last Updated

February 28, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)NO(1)