Why do People With Low Back Pain Fear and Avoid Lifting?

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Cross-sectional self-report (questionnaires)

• Study Type: Interventional
• Enrollment (Anticipated): 325
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Matheve, PhD; Phone Number: 32(0)11 28 69 39; Email: Thomas.Matheve@uhasselt.be

Study Locations

• Belgium
  • Hasselt, Belgium, 3500
    • Hasselt University
    • Contact: Lotte Janssens, PhD; Email: lotte.janssens@uhasselt.be
    • Contact: Thomas Matheve, PhD; Email: Thomas.Matheve@uhasselt.be
    • Principal Investigator: Thomas Matheve, PhD
    • Principal Investigator: Lotte Janssens, PhD
    • Principal Investigator: Katleen Bogaerts, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• low back pain >3 months

Exclusion Criteria:

• healthy persons
• low back pain <3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Other: Cross-sectional self-report (questionnaires); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain-related fear	Tampa Scale for Kinesiophobia 11-item version questionaire (range= 11-44. Higher score = higher levels of pain-related fear)	Day 1 (cross-sectional study)
perceived harmfulness of specific tasks	perceived harmfulness of specific tasks measured with a selection of pictures of the Photographs of Daily Activities - Short Electronic version. Each picture will be scored on a 0-100 scale, with higher scores indicating higher levels of perceived harmfulness	Day 1 (cross-sectional study)
Disability	Roland Morris Disability Questionnaire (score range= 0-24, higher score= higher level of disbility)	Day 1 (cross-sectional study)
Task-specific self-efficacy	For different tasks, participants will be asked to rate the task-specific self-efficacy on a 0-10 Visual analogue scale (higher scores= higher levels of self-efficacy)	Day 1 (cross-sectional study)
Task-specific disability	For different tasks, participants will be asked to rate their perceived disability on a 0-10 Visual analogue scale (higher scores= higher levels of disability)	Day 1 (cross-sectional study)
Pain-related fear	Fear-Avoidance Beliefs Questionnaire. The Activity Avoidance Subscale (score range= 0-24) and Work subscale (score range= 0-42) will both be used. Higher scores indicate higher levels of pain-related fear	Day 1 (cross-sectional study)
Pain intensity	Numeric rating scale (0-10, higher score= higher level of pain)	Day 1 (cross-sectional study)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	years	Day 1 (cross-sectional study)
Sex	Male, female, other	Day 1 (cross-sectional study)
Physical job requirements	Questionnaire (derived from de Dutch Musculoskeletal Questionnaire) asking about physical job requirements	Day 1 (cross-sectional study)

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Principal Investigator: Thomas Matheve, PhD, Hasselt University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: December 30, 2021
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: ThomasMatheve-2021-3

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