NCT05192187

Brief Summary

The investigators' main focus of this trial will be to investigate

  • why people with low back pain perceive lifting (with a bent back) as harmful.
  • whether general measures of pain-related fear are associated with task-specific measures of perceived harmfulness
  • why people with low back pain avoid lifting (with a bent back) This will be investigated using self-report (i.e., questionnaires)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
325

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

December 22, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

1.4 years

First QC Date

December 22, 2021

Last Update Submit

January 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • cognitions about perceived harmfulness and avoidance of lifting

    cognitions about perceived harmfulness and avoidance of lifting using self-developed questionnaires. Questions will be scored on a 1-5 Likert scale (1= completely disagree, 5= completely agree)

    Day 1 (cross-sectional study)

Secondary Outcomes (7)

  • Pain-related fear

    Day 1 (cross-sectional study)

  • perceived harmfulness of specific tasks

    Day 1 (cross-sectional study)

  • Disability

    Day 1 (cross-sectional study)

  • Task-specific self-efficacy

    Day 1 (cross-sectional study)

  • Task-specific disability

    Day 1 (cross-sectional study)

  • +2 more secondary outcomes

Other Outcomes (3)

  • Age

    Day 1 (cross-sectional study)

  • Sex

    Day 1 (cross-sectional study)

  • Physical job requirements

    Day 1 (cross-sectional study)

Study Arms (1)

LBP

EXPERIMENTAL

This group will be asked to complete self-reported questionnaires on a single occasion (cross-sectional)

Other: Cross-sectional self-report (questionnaires)

Interventions

participants in this group will be ask to complete questionnaires on one occasion (i.e., cross-sectional investigation). The questionnaires will consist of a self-developed questionnaire and standard questionnaires. The main aspects of the self-developed questionnaires are * perceived harmfulness of activities (selection of PHODA-SeV) * cognitions about lifting and pain * reasons for avoidance behaviour (lifting) Standardised questionnaires include * NRS for pain * TSK-11 * FABQ * RMDQ

LBP

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • low back pain \>3 months

You may not qualify if:

  • healthy persons
  • low back pain \<3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Thomas Matheve, PhD

    Hasselt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral researcher

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 14, 2022

Study Start

February 1, 2022

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

February 2, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations