Back to resultsWhy do People With Low Back Pain Fear and Avoid Lifting?
Primary Purpose
Low Back Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cross-sectional self-report (questionnaires)
Sponsored by
About this trial
This is an interventional other trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- low back pain >3 months
Exclusion Criteria:
- healthy persons
- low back pain <3 months
Sites / Locations
- Hasselt University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LBP
Arm Description
This group will be asked to complete self-reported questionnaires on a single occasion (cross-sectional)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Pain-related fear
Tampa Scale for Kinesiophobia 11-item version questionaire (range= 11-44. Higher score = higher levels of pain-related fear)
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
Disability
Roland Morris Disability Questionnaire (score range= 0-24, higher score= higher level of disbility)
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)
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)
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
Pain intensity
Numeric rating scale (0-10, higher score= higher level of pain)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05192187
Brief Title
Why do People With Low Back Pain Fear and Avoid Lifting?
Official Title
Why do People With Low Back Pain Fear and Avoid Lifting?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
325 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LBP
Arm Type
Experimental
Arm Description
This group will be asked to complete self-reported questionnaires on a single occasion (cross-sectional)
Intervention Type
Other
Intervention Name(s)
Cross-sectional self-report (questionnaires)
Intervention Description
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
Primary Outcome Measure Information:
Title
cognitions about perceived harmfulness and avoidance of lifting
Description
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)
Time Frame
Day 1 (cross-sectional study)
Secondary Outcome Measure Information:
Title
Pain-related fear
Description
Tampa Scale for Kinesiophobia 11-item version questionaire (range= 11-44. Higher score = higher levels of pain-related fear)
Time Frame
Day 1 (cross-sectional study)
Title
perceived harmfulness of specific tasks
Description
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
Time Frame
Day 1 (cross-sectional study)
Title
Disability
Description
Roland Morris Disability Questionnaire (score range= 0-24, higher score= higher level of disbility)
Time Frame
Day 1 (cross-sectional study)
Title
Task-specific self-efficacy
Description
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)
Time Frame
Day 1 (cross-sectional study)
Title
Task-specific disability
Description
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)
Time Frame
Day 1 (cross-sectional study)
Title
Pain-related fear
Description
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
Time Frame
Day 1 (cross-sectional study)
Title
Pain intensity
Description
Numeric rating scale (0-10, higher score= higher level of pain)
Time Frame
Day 1 (cross-sectional study)
Other Pre-specified Outcome Measures:
Title
Age
Description
years
Time Frame
Day 1 (cross-sectional study)
Title
Sex
Description
Male, female, other
Time Frame
Day 1 (cross-sectional study)
Title
Physical job requirements
Description
Questionnaire (derived from de Dutch Musculoskeletal Questionnaire) asking about physical job requirements
Time Frame
Day 1 (cross-sectional study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
low back pain >3 months
Exclusion Criteria:
healthy persons
low back pain <3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Matheve, PhD
Phone
32(0)11 28 69 39
Email
Thomas.Matheve@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Matheve, PhD
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasselt University
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Matheve, PhD
Email
Thomas.Matheve@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Lotte Janssens, PhD
Email
Lotte.Janssens@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Thomas Matheve, PhD
First Name & Middle Initial & Last Name & Degree
Lotte Janssens, PhD
First Name & Middle Initial & Last Name & Degree
Katleen Bogaerts, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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