Low Back Activity Confidence Scale: Cross-cultural Adaptation, Reliability, and Validity of the Turkish Version

December 10, 2022 updated by: Halime ARIKAN, Gazi University
This study is aimed to carry out the Turkish version validity and reliability of the Low Back Activity Confidence Scale.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

Detailed Description

Because self-efficacy represents a situation-specific construct and not a general or personality construct, confidence in performing one type of activity can differ significantly from confidence in performing other actions, all of which can contribute to a common outcome. Optimally, self-efficacy measures are tailored to assess individuals' confidence in exhibiting key behaviors related to recovery or alleviation from their own health condition or condition. Therefore, self-efficacy scales involve measuring an individual's confidence in each unique behavior or set of behaviors. Self-efficacy also explained more discomfort than pain intensity in patients with chronic pain. In addition, with appropriate insight and assessment, self-efficacy can perhaps be developed more effectively or appropriately than other non-modifiable (e.g. demographics) or less easily modifiable factors, such as fear beliefs and catastrophic thinking. Although several instruments have been developed to assess self-efficacy in low back pain, they do not address relevant functional and self-regulatory behaviors in the post-intervention clinical population. Therefore, the Low Back Activity Confidence Scale (LoBACS) was created to assess various forms of self-efficacy potentially related to low back pain. LoBACS is general, non-work-specific, but self-efficacy for backward functional activities such as standing, carrying, and pushing, self-regulation or self-control to manage one's thoughts, emotions, and behaviors to perform or avoid activities that may contribute to back health. and self-efficacy to do regular exercise, a core activity in a range of therapeutic interventions for low back pain. There is no Turkish version and validity study of LoBACS. This study is aimed to evaluate the validity and reliability of the Turkish version of LoBACS. The study of validity and reliability is planned with 104 individuals with low back pain. The sociodemographic characteristics of the individuals will be questioned by the investigators and then the patients will be evaluated with LoBACS, International Physical Activity Questionnaire (IPAQ), Back Pain Functional Scale (BPFS), Waddell Disability Index (WDI), Modified Oswestry Disability Index (MODI), Roland-Morris Disability Questionnaire (RMDQ), Short Form-36 (SF-36), Fear Avoidance Beliefs Questionnaire (FABQ) and Visual Analogue Scale (VAS). The test-retest will be re-administered by face-to-face interview technique after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.

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.
Observational

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.
104

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 Contact Backup

Study Locations

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

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with low back pain between the ages of 18-60

Description

Inclusion Criteria:

  • have any diagnosis of low back pain;
  • who have had low back pain for at least 3 months;
  • at least 18 years;
  • to be able to read and write in Turkish;
  • to volunteer.

Exclusion Criteria:

  • poor knowledge of Turkish language;
  • cognitive impairment;
  • the presence of psychiatric limitations;
  • chronic degenerative inflammatory or neurologic disorders;
  • infections;
  • systemic disorders;
  • pregnancy.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Patients group
Patients with low back pain
Other: No intervention will be applied.
This is a questionnaire study.

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
Low Back Activity Confidence Scale (LoBACS)
Time Frame: Two assessments- 7 minutes
It was developed as a scale consisting of 15 items and 3 subscales in 2011 and was organized based on theoretical, rational distinctions and content. The functional self-efficacy subscale includes 7 items related to self-confidence for challenging functional activities (i.e. carrying, lifting, pushing, sitting, standing, walking, and climbing stairs), which are frequently mentioned for individuals with low back pain. The self-regulatory self-efficacy subscale includes 3 items related to confidence in caring for, controlling and coping with a back problem. Exercise self-efficacy subscale includes 5 items related to maintaining regular exercise for back health in different disability situations. Each item is evaluated on an 11-point scale ranging from 0% (no confidence) to 100% (full confidence), marked in 10% increments. A high score indicates a high level of confidence.
Two assessments- 7 minutes
Back Pain Functional Scale (BPFS)
Time Frame: Single assessment- 7 minutes
It is a scale that evaluates how much activity and functions of individuals are affected by their current low back pain complaints. Functions and activities evaluated in the scale; work, school, indoor activities, general habits, bending forward, wearing shoes/socks, lifting something from the ground, sleeping, sitting, standing, walking, going up/down stairs and driving. Individuals who do not drive can answer the last question as traveling. Each expression is scored between 0 and 5. The maximum score is 60 points, while the minimum score is 0. A score of 60 indicates that there is no difficulty in performance. The Turkish validity and reliability of the scale has been proven.
Single assessment- 7 minutes
Waddell Disability Index (WDI)
Time Frame: Single assessment- 5 minutes
It is used to evaluate the basic physical activities of daily life restricted by low back pain. It consists of 9 two-ended (yes/no) items, the total score is calculated by adding up the yes answers. The highest score of WDI is 9, and higher scores indicate more severe disability
Single assessment- 5 minutes
Modified Oswestry Disability Index (MODI)
Time Frame: Single assessment- 5 minutes
It includes 10 questions about pain intensity, personal care, lifting weights, walking, sitting, standing, sleeping, social life, travel and change in pain over time, each question has 6 options. The individual is asked to choose the one that best describes his/her situation from the options between 0 and 5 points in each question. The highest score is 50 points. An increase in the score indicates an increase in functional limitation, while a decrease in the score indicates an increase in functional level. According to the sum of the points, the evaluation is made as follows; 0 points: no functional disability, 1-10 points: mild functional disability, 11-30 points: moderate functional disability, 31-50 points: severe functional disability. The Turkish version, validity and reliability study was performed.
Single assessment- 5 minutes
Roland Morris Disability Questionnaire (RMDQ)
Time Frame: Single assessment- 10 minutes
It consists of 24 questions answered as 'Yes' or 'No'. 1 point is awarded for each yes answer and 0 for each no answer. The total score is found by adding the given points. The total score is between 0-24 values. High scores indicate a lack of physical activity. The Turkish version, validity and reliability study was performed.
Single assessment- 10 minutes
International Physical Activity Questionnaire (IPAQ)
Time Frame: Single assessment- 5 minutes
It is used to determine the physical activity levels of individuals. The short form consisting of 7 items divides the activity into different intensity levels as vigorous, moderate and walking. The time spent sitting is considered as a separate question. Turkish version, validity and reliability study was conducted in 2010.
Single assessment- 5 minutes
Short Form-36 (SF-36)
Time Frame: Single assessment- 12 minutes
It is one of the most common generic measures used to measure quality of life. This scale examines 8 dimensions of health, such as physical function, role limitations (due to physical and emotional problems), social function, mental health, vitality (energy), pain and general perception of health, with 36 items. While the maximum value of Short Form-36 is 100, its minimum value is 0. Increased scores indicate a better quality of life. As the score decreases, the quality of life worsens. The Turkish version, validity and reliability study of the scale was performed.
Single assessment- 12 minutes
Fear Avoidance Beliefs Questionnaire (FABQ)
Time Frame: Single assessment- 5 minutes
It is a questionnaire consisting of two sub-scales, physical activity and work activity, and 16 questions. The main purpose is to show the effect of activity-induced fear and avoidance belief on low back pain and disability. It is based on the strong relationship between increased fear avoidance belief and chronic disability due to low back pain. While the maximum value of Fear Avoidance Beliefs Questionnaire is 66, its minimum value is 0. In the evaluation, it is accepted that fear-avoidance behavior decreases as the total score approaches 0, and increases in fear-avoidance behavior as it approaches the maximum score. The Turkish version, validity and reliability study was performed.
Single assessment- 5 minutes
Visual Analog Scale (VAS)
Time Frame: Single assessment- 1 minute
It consists of a 10-centimeter straight line starting from 0 on the left to the right. A value of 0 is defined as "no pain" and a value of 10 as "worst pain". Individuals are instructed to draw a vertical line on the horizontal line that indicates where on the line the pain they are feeling is, and the length of the line is measured. The Turkish validity and reliability study of the VAS was performed.
Single assessment- 1 minute

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.
Gazi 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.
  • Study Chair: Halime ARIKAN, PhD, Tokat Gaziosmanpasa 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 (Actual)

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.
November 10, 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.
November 10, 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.
November 10, 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).
November 28, 2022

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 10, 2022

First Posted (Estimate)

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.
December 13, 2022

Study Record Updates

Last Update Posted (Estimate)

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.
December 13, 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.
December 10, 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.
December 1, 2022

More Information

Terms related to this study

Keywords

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.
  • 83116987-704

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

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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