Validity and Reliability of the Turkish Version of the Low Back Activity Confidence Scale (Lobacs)

July 1, 2023 updated by: Sezin Solum, Bursa City Hospital

Patients will be recruited from the Outpatient Department of Physical Medicine and Rehabilitation, Kestel State Hospital, who have been diagnosed with mechanical LBP for the past 3 weeks (physical examination, neurological examination, spinal radiography and laboratory tests and other causes of LBP were excluded) and who have agreed to participate in the study. Sociodemographic data of patients who gave written informed consent will be recorded to ensure anonymity. Although no consensus has been reached on the cross-cultural adaptation of the questionnaires into different languages, this study will use the guidelines for self-report measurement provided by Beaton et al. Following the formation of the expert committee, the scale will be translated and the pre-form back-translated. Comparisons will be made with the translated versions and the final version of the scale will be created by taking into account the opinions of the preliminary group of participants.

The reliability, test-retest reliability, face validity and content validity of the scale will be assessed by the expert committee. In order to assess the concurrent validity of this scale, all participants will also complete the 'Oswestry Low Back Pain Disability Questionnaire' and the 'Quebec Low Back Pain Disability Questionnaire', which have been previously validated and reliable in Turkish.

The Oswestry Low Back Pain Disability Questionnaire consists of 10 items that assess activities of daily living. These are pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, travelling and degree of change in pain. Each item has 6 options ranging from 0 to 5 points (12). The Quebec Low Back Pain Disability Questionnaire consists of 20 items assessing activities of daily living. Each item has 6 options ranging from 0-5 points.

The aim of this study was to evaluate the validity and reliability and the Turkish version of the Low Back Activity Confidence Scale (Lobacs).

Study Overview

Status

Status

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

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

Patients will be recruited from the Outpatient Department of Physical Medicine and Rehabilitation, Kestel State Hospital, who have been diagnosed with mechanical LBP for the past 3 weeks (physical examination, neurological examination, spinal radiography and laboratory tests and other causes of LBP were excluded) and who have agreed to participate in the study. Sociodemographic data of patients who gave written informed consent will be recorded to ensure anonymity. Although no consensus has been reached on the cross-cultural adaptation of the questionnaires into different languages, this study will use the guidelines for self-report measurement provided by Beaton et al. Following the formation of the expert committee, the scale will be translated and the pre-form back-translated. Comparisons will be made with the translated versions and the final version of the scale will be created by taking into account the opinions of the preliminary group of participants.

The reliability, test-retest reliability, face validity and content validity of the scale will be assessed by the expert committee. In order to assess the concurrent validity of this scale, all participants will also complete the 'Oswestry Low Back Pain Disability Questionnaire' and the 'Quebec Low Back Pain Disability Questionnaire', which have been previously validated and reliable in Turkish.

The aim of this study was to evaluate the validity and reliability and the Turkish version of the Low Back Activity Confidence Scale (Lobacs).

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 (Actual)

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.
150

Contacts and Locations

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

Study Locations

  • Turkey
      • Bursa, Turkey
        • Bursa Kestel State Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients will be recruited from the Outpatient Department of Physical Medicine and Rehabilitation, Kestel State Hospital, who have been diagnosed with mechanical LBP for the past 3 weeks (physical examination, neurological examination, spinal radiography and laboratory tests and other causes of LBP were excluded) and who have agreed to participate in the study.

Description

Inclusion Criteria:

  • Presence of mechanical low back pain for 3 weeks or more.

Exclusion Criteria:

  • Duration of pain is less than 3 weeks,
  • Evidence of non-mechanical causes of low back pain on imaging or laboratory tests.
  • Inflammatory diseases.
  • History of major surgery in the last 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

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: baseline
The Low Back Activity Confidence Scale (LOBACS) is a self-report questionnaire comprising 15 items and three subscales: Functional Self-efficacy (FnSE), Self-regulatory Self-efficacy, and Exercise Self-efficacy (ExSE). Its purpose is to evaluate an individual's perceived functional ability and the impact of low back pain on their daily life and functional performance. The questionnaire employs an 11-point Likert scale, ranging from 0% (no confidence) to 100% (complete confidence), with 10% increments for each point. Scores can be calculated globally (e.g., average score of all items) or for specific domains (e.g., average score of items 1-7 for FnSE subscale). The total score can range from 0 to 100, where higher scores indicate greater self-efficacy.
baseline
The Oswestry Back Pain Disability Questionnaire
Time Frame: baseline
The Oswestry Back Pain Disability Questionnaire comprises 10 items that inquire about various daily activities, including pain intensity, self-care, lifting, walking, sitting, standing, sleeping, social life, traveling, and the extent of pain-related changes. Each item presents six response options, scored on a scale of 0 to 5 points.
baseline
The Quebec back pain disability scale (QBPDS)
Time Frame: baseline
The Quebec Back Pain Disability Scale consists of 20 daily activities that can be categorised into 6 types of activities: Sitting/standing, Walking, Moving, Bending, Bed/resting, Handling large/heavy objects. For each activity there are 6 response scores on a Likert scale from 0-5 (0 = no effort, 5 = unable). If the person feels really bad, they give it a score of 5. If they feel good with no problems, they give it a score of 0.
baseline

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.
Bursa City Hospital

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 Director: Ender Salbaş, MD, Balikesir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
July 1, 2021

Primary Completion (Actual)

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.
January 1, 2022

Study Completion (Actual)

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.
January 1, 2022

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).
June 23, 2023

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.
June 23, 2023

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.
July 3, 2023

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.
July 5, 2023

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.
July 1, 2023

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.
July 1, 2023

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.
  • 9999999992

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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Conditions

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