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

January 28, 2022 updated by: Thomas Matheve, Hasselt University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
325

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Hasselt, Belgium, 3500
        • Hasselt University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Matheve, PhD
        • Principal Investigator:
          • Lotte Janssens, PhD
        • Principal Investigator:
          • Katleen Bogaerts, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
cognitions about perceived harmfulness and avoidance of lifting
Time Frame: Day 1 (cross-sectional study)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain-related fear
Time Frame: Day 1 (cross-sectional study)
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
Time Frame: Day 1 (cross-sectional study)
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
Time Frame: Day 1 (cross-sectional study)
Roland Morris Disability Questionnaire (score range= 0-24, higher score= higher level of disbility)
Day 1 (cross-sectional study)
Task-specific self-efficacy
Time Frame: Day 1 (cross-sectional study)
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
Time Frame: Day 1 (cross-sectional study)
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
Time Frame: Day 1 (cross-sectional study)
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
Time Frame: Day 1 (cross-sectional study)
Numeric rating scale (0-10, higher score= higher level of pain)
Day 1 (cross-sectional study)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age
Time Frame: Day 1 (cross-sectional study)
years
Day 1 (cross-sectional study)
Sex
Time Frame: Day 1 (cross-sectional study)
Male, female, other
Day 1 (cross-sectional study)
Physical job requirements
Time Frame: Day 1 (cross-sectional study)
Questionnaire (derived from de Dutch Musculoskeletal Questionnaire) asking about physical job requirements
Day 1 (cross-sectional study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasselt University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Matheve, PhD, Hasselt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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