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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05192187
Other study ID # ThomasMatheve-2021-3
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2022
Est. completion date December 31, 2023

Study information

Verified date January 2022
Source Hasselt University
Contact Thomas Matheve, PhD
Phone 32(0)11 28 69 39
Email Thomas.Matheve@uhasselt.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 325
Est. completion date December 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - low back pain >3 months Exclusion Criteria: - healthy persons - low back pain <3 months

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium Hasselt University Hasselt

Sponsors (1)

Lead Sponsor Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other Age years Day 1 (cross-sectional study)
Other Sex Male, female, other Day 1 (cross-sectional study)
Other Physical job requirements Questionnaire (derived from de Dutch Musculoskeletal Questionnaire) asking about physical job requirements Day 1 (cross-sectional study)
Primary 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 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)
Secondary 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)
Secondary Disability Roland Morris Disability Questionnaire (score range= 0-24, higher score= higher level of disbility) Day 1 (cross-sectional study)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary Pain intensity Numeric rating scale (0-10, higher score= higher level of pain) Day 1 (cross-sectional study)
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