NCT05284669

Brief Summary

The purpose of the current research project is to examine if the healthcare professionals (HCPs) knowledge, attitudes, beliefs and behavior about the management of low back pain (LBP) patients changes following an e-learning intervention (experimental interactive e-learning versus traditional non-interactive e-learning)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 27, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

1.3 years

First QC Date

March 10, 2022

Last Update Submit

May 9, 2023

Conditions

Keywords

Distance educationMusculoskeletal painGuideline adherenceFirst-line care

Outcome Measures

Primary Outcomes (2)

  • The Health Care Providers Pain and Impairment Relationship Scale (HC-PAIRS)

    The HC-PAIRS assesses attitudes and beliefs about functional expectations for patients with chronic LBP. It consists of 13 statements that must be rated on a seven-point Likert scale, ranging from 'totally disagree' to 'totally agree'. A high score on the HC-PAIRS reflects a belief with a strong relationship between pain and impairment. Psychometric properties of this questionnaire have been established.

    Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)

  • Vignette of Rainville

    The clinical vignette described a patient with non-specific LBP. This vignette was developed by Rainville. Participants were asked to assess the patient's ability to work, from 1 (full-time) to 5 (remain out of work) and gave their opinion on the appropriate level of activity, with choices graded from 1 (no limitations on activity) to 5 (limit all physical activity). If the score of the participant was between 1 and 2 it was considered guideline adherent. If the score was between 3 and 5 it was considered guidelines discordant.

    Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)

Secondary Outcomes (5)

  • The Back Pain and Attitudes Questionnaire (Back-PAQ ; 10-items version)

    Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)

  • The Neurophysiology of Pain Questionnaire (NPQ)

    Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)

  • Fictive clinical cases of patients with LBP

    Baseline assessment and post-intervention assessment (between 2 and 4 weeks after baseline)

  • Experiences of HCPs with the e-learning (quantitative)

    Post-intervention assessment (between 2 and 4 weeks after baseline)

  • Experiences of HCPs with the e-learning (qualitative)

    Between 4 and 6 weeks after baseline

Study Arms (2)

Experimental e-learning

EXPERIMENTAL

The experimental interactive intervention is based on international guidelines for the management of LBP and includes multiple interactions with the participant in a virtual environment. Metaphors and concrete clinical situations are presented to translate the knowledge (i.e. the management of low back pain from a biopsychosocial point of view) to clinical practice. Interactions consists of videos, open and closed questions and audio records.

Other: Experimental e-learning

Traditional e-learning

OTHER

The traditional intervention consists of a traditional online lecture based on international guidelines for the management of LBP without any interaction. The focus is more fundamental (theoretical) without metaphors or clinical cases.

Other: Traditional e-learning

Interventions

Interactive lecture based on the guidelines for the management of LBP with a focus on self-management and patient's reassurance

Experimental e-learning

Traditional lecture based on the guidelines for the management of LBP with a focus on diagnostic triage and specific cause of LBP

Traditional e-learning

Eligibility Criteria

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

You may qualify if:

  • To be an healthcare practitioner (general practitioner, physiotherapist, specialist physician, student in medicine including specialization, student in physiotherapy)
  • Working or studying in Belgium or France
  • Being in possession of an internet connected device (e.g. computer, tablet or smartphone) with speaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Online study

Brussels, Belgium

Location

Related Publications (1)

  • Fourre A, Fierens A, Michielsen J, Ris L, Dierick F, Roussel N. An interactive e-learning module to promote bio-psycho-social management of low back pain in healthcare professionals: a pilot study. J Man Manip Ther. 2022 Apr;30(2):105-115. doi: 10.1080/10669817.2021.1988397. Epub 2021 Oct 22.

Related Links

MeSH Terms

Conditions

BehaviorLow Back PainMusculoskeletal Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Nathalie Roussel, PhD

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR
  • Laurence Ris, PhD

    University of Mons

    STUDY DIRECTOR
  • Antoine Fourré, MSc

    University of Mons / University of Antwerp

    PRINCIPAL INVESTIGATOR
  • Rob Vanderstraeten, MSc

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR
  • Jef Michielsen, MD, PhD

    Universiteit Antwerpen

    STUDY DIRECTOR
  • Hilde Bastiaens, MD, PhD

    Universiteit Antwerpen

    STUDY DIRECTOR
  • Sybil Anthierens, PhD

    Universiteit Antwerpen

    STUDY DIRECTOR
  • Frédéric Telliez, PhD

    Universite de Picardie Jules Verne

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD student - Research Assistant

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 17, 2022

Study Start

August 27, 2021

Primary Completion

December 31, 2022

Study Completion

March 1, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations