NCT05649215

Brief Summary

This study is aimed to carry out the Turkish version validity and reliability of the Low Back Activity Confidence Scale.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2023

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

November 28, 2022

Last Update Submit

December 10, 2022

Conditions

Keywords

Low Back PainTurkish versionTranslationReliabilityValidity

Outcome Measures

Primary Outcomes (9)

  • Low Back Activity Confidence Scale (LoBACS)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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

Study Arms (1)

Patients group

Patients with low back pain

Other: No intervention will be applied.

Interventions

This is a questionnaire study.

Patients group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 06490, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Halime ARIKAN, PhD

    Tokat Gaziosmanpasa University

    STUDY CHAIR

Central Study Contacts

Tuğçe ÇOBAN, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 28, 2022

First Posted

December 13, 2022

Study Start

November 10, 2022

Primary Completion

November 10, 2023

Study Completion

November 10, 2023

Last Updated

December 13, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

Locations