Chronic Low-back Pain (cLBP)NCT06694493
Factors Associated With Quality of Life in Chronic Low Back Pain
An observational study of Chronic Low-back Pain (cLBP), run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to identify and validate the factors that may affect quality of life in patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain (cLBP)
- How many people
- 174 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Nov 2024to 22 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People between the ages of 18-65, who volunteered to participate in the study, and who had low back pain for more than 3 months will be included in the study.
Who may be able to join
- Volunteering to participate in the study
- Having low back pain for more than 3 months
- Being between the ages of 18-65
Who cannot join
- History of surgery in the spinal region
- Rheumatoid arthritis
- Tumour
- Autoimmune disease
- Neurological disease
- Psychiatric or cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Associated With Quality of Life in Chronic Low Back Pain: A Structural Equation Modelling Study
The aim of this study was to identify and validate the factors that may affect quality of life in patients with chronic low back pain.
Read the detailed description
Participants between the ages of 18-65, who are willing to participate in the study and have low back pain for more than 3 months will be included in the study. The necessary demographic information will be obtained with a data form. For the evaluation; Visual Analogue Scale (VAS), Tampa Kinesiophobia Scale, Fear-Avoidance Beliefs Questionnaire, Roland-Morris Disability Questionnaire, Beck Depression Scale, Self-Efficacy for Managing Chronic Disease 6-Item Scale, Coping Strategies Inventory Short Form (CSI-SF), Pain Catastrophising Scale, Pittsburgh Sleep Quality Index, Short Form - 36 (Quality of Life Questionnaire) will be used. The data obtained in the study will be entered into SPSS 17 package programme (Greasley, 2007). Minimum-maximum values, arithmetic mean and standard deviation will be used to evaluate numerical data, and frequency distributions and percentages will be used to summarise categorical data. The data of the study will be analysed using Analysis of Moment Structures (AMOS) statistical package programmes. In all analyses, p<0.05 will be considered statistically significant.
- Conditions
- Chronic Low-back Pain (cLBP)
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Visual Analogue Scale (VAS) will be used to assess the pain intensity of the patients. Patients will be given a paper with a 10 cm straight line with numbers between 0 and 10 on it and asked to score according to the severity of pain. 0 points will be given in the absence of pain and 10 points will be given in the most severe pain.
Measured: 1 minute
Tampa Kinesiophobia Scale
The TKS is a 17-question scale and is used in acute and chronic low back pain, fibromyalgia and musculoskeletal injuries and whiplash-related disorders. The scale has a 4-point Likert scale (1= Strongly disagree, 4= Strongly agree). The total score is calculated after reversing items 4, 8, 12 and 16. The person receives a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia. The Turkish reliability study of the Tampa Kinesiophobia Scale was conducted by Yılmaz et al. (2011)
Measured: 5 minute
Fear-Avoidance Beliefs Questionnaire
Fear Avoidance Beliefs Questionnaire consists of 16 questions. It has two subscales: physical activity and work. The physical activity section consists of 5 questions and the work section consists of 11 questions. The questionnaire is a 7-point Likert type scale. The answers to the questionnaire are between strongly disagree (0 points) and strongly agree (6 points). Items 1, 8, 13, 14 and 16 are not included in the scoring. The Physical Activity section can receive a minimum of 0 and a maximum of 24 points. The labour section can score a minimum of 0 and a maximum of 42 points. As the total score approaches 0, it is accepted that there is a decrease in fear-avoidance behaviour within the section, and as it approaches the maximum score, it is accepted that there is an increase in fear-avoidance behaviour. The Turkish reliability and validity study of the Fear-Avoidance Beliefs Questionnaire was conducted by Bingül et al.
Measured: 5 minute
Roland-Morris Disability Questionnaire
Roland Morris Disability Questionnaire was published by Roland and Morris in 1983 (Roland \& Fairbank, 2000). It consists of 24 questions about the person's perception of low back pain and related disability. It consists of physical ability/activity (15), sleep/rest (3), psychosocial (2), home management (2), eating (1) and pain frequency (1). Patients are asked to answer all questions 'yes/no'. Each 'yes' answer is scored as 1 and each 'no' answer is scored as 0. Total score for 24 questions is calculated. In this questionnaire, a high score indicates a bad score. The Turkish validation study of the Roland-Morris Disability Questionnaire was conducted by Küçükdeveci et al.
Measured: 5 minute
Beck Depression Scale
The Beck Depression Scale is a self-report questionnaire that assesses the presence and severity of depressive symptoms. It consists of 21 items. Each item is scored on a four-point scale ranging from 0 (none) to 3 (severe). Total scores can vary between 0 and 63. The reliability and validity findings of the questionnaire adapted to Turkish have been obtained.
Measured: 5 minute
Self-Efficacy for Managing Chronic Disease 6-Item Scale
Self-Efficacy for Managing Chronic Disease 6-Item Scale was developed by Lorig and colleagues in English in 2001 (Lorig, Sobel, Ritter, Laurent, \& Hobbs, 2001). The scale is graded on a 10-point scale ranging from 'not at all confident' to 'completely confident'. The scale score is the average of 6 items. High scores indicate high self-efficacy. If more than 1 response is given to an item and the items are consecutive, the low score is included in the calculation. If 2 responses are not consecutive, this item is excluded from the calculation. In order to calculate the scale, at least 4 items must be answered. The Turkish version is a valid and reliable tool for assessing the perceived self-efficacy level of patients with chronic diseases.
Measured: 3 minute
Coping Strategies Inventory Short Form (CSI-SF)
Coping Strategies Long Form is the short form developed by Carver (1997) after being revised. Coping Strategies Inventory Short Form consists of 28 questions and 14 subscales. Responses to each item are evaluated in the range of 1-4 points. The raw score that can be obtained from the subscales varies between 2-8.
Measured: 5 minute
Pain Catastrophising Scale
The Catastrophising Pain Scale (PCS) is used to measure catastrophising in response to pain through 13 statements with four possible options from 1 'never' to 4 'always'. Higher scores indicate greater catastrophised pain. The Turkish validity study of the scale was conducted by Süren et al. (2014)
Measured: 5 minute
Pittsburgh Sleep Quality Index (PSQI)
PSQI is a scale developed to evaluate sleep quality and sleep disturbance in a one-month period. PSQI consists of 24 questions in total. The first 18 questions answered by the participant himself/herself are used in the calculation of the PSQI total score and component scores. The 18 items included in the scoring are grouped into 7 components. Each item is evaluated in the range of 0-3 points. The sum of the seven component scores constitutes the result of the PSQI. The lowest score is zero and the highest score is 21. A high total score indicates poor sleep quality. The sleep quality of individuals with a total score of 5 and below is considered 'good', while the sleep quality of individuals with a score above 5 is considered 'poor'. The validity and reliability study of the PSQI was conducted by Agargun et al. (1996) in our country.
Measured: 5 minute
Short Form - 36 Quality of Life Questionnaire (SF-36)
The Short Form - 36 Quality of Life Questionnaire (SF-36) is a general measure of health status, rather than measuring the outcomes of specific conditions. There is evidence that the SF-36 can be used to monitor musculoskeletal conditions. The SF-36 is a health-related quality of life questionnaire consisting of 8 scales (physical functioning, role limitations due to physical health problems, pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, mental health). Responses to items are converted into scale scores from 0 (worst health) to 100 (best health). One physical and one mental summary health measure are derived from the 8 scales.
Measured: 7 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start29 Nov 2024
- Primary completion22 Mar 2025
- Study completion22 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back Pain (cLBP)Studies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emrah Afsar, Kutahya Health Sciences University
- Investigators
- Emrah Afsar, Phd, Principal investigator, Kutahya Health Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694493
- Sponsor's protocol ID
- 2024-d
- Status last verified
- Aug 2025
- First submitted
- 15 Nov 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Quality of Life in Chronic Low Back Pain: A Structural Equation Modelling Study
- ClinicalTrials.gov ID
- NCT06694493
- Acronym / sponsor ID
- 2024-d
- Conditions
- Chronic Low-back Pain (cLBP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 22 Mar 2025 (actual)
- Study completion
- 22 Mar 2025 (actual)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to identify and validate the factors that may affect quality of life in patients with chronic low back pain.
Detailed description
Participants between the ages of 18-65, who are willing to participate in the study and have low back pain for more than 3 months will be included in the study. The necessary demographic information will be obtained with a data form. For the evaluation; Visual Analogue Scale (VAS), Tampa Kinesiophobia Scale, Fear-Avoidance Beliefs Questionnaire, Roland-Morris Disability Questionnaire, Beck Depression Scale, Self-Efficacy for Managing Chronic Disease 6-Item Scale, Coping Strategies Inventory Short Form (CSI-SF), Pain Catastrophising Scale, Pittsburgh Sleep Quality Index, Short Form - 36 (Quality of Life Questionnaire) will be used. The data obtained in the study will be entered into SPSS 17 package programme (Greasley, 2007). Minimum-maximum values, arithmetic mean and standard deviation will be used to evaluate numerical data, and frequency distributions and percentages will be used to summarise categorical data. The data of the study will be analysed using Analysis of Moment Structures (AMOS) statistical package programmes. In all analyses, p<0.05 will be considered statistically significant.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People between the ages of 18-65, who volunteered to participate in the study, and who had low back pain for more than 3 months will be included in the study.
Key inclusion criteria (3 listed)
- Volunteering to participate in the study
- Having low back pain for more than 3 months
- Being between the ages of 18-65
Key exclusion criteria (6 listed)
- History of surgery in the spinal region
- Rheumatoid arthritis
- Tumour
- Autoimmune disease
- Neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Analogue Scale
Time frame: 1 minute
Visual Analogue Scale (VAS) will be used to assess the pain intensity of the patients. Patients will be given a paper with a 10 cm straight line with numbers between 0 and 10 on it and asked to score according to the severity of pain. 0 points will be given in the absence of pain and 10 points will be given in the most severe pain.
Tampa Kinesiophobia Scale
Time frame: 5 minute
The TKS is a 17-question scale and is used in acute and chronic low back pain, fibromyalgia and musculoskeletal injuries and whiplash-related disorders. The scale has a 4-point Likert scale (1= Strongly disagree, 4= Strongly agree). The total score is calculated after reversing items 4, 8, 12 and 16. The person receives a total score between 17-68. A high score on the scale indicates a high level of kinesiophobia. The Turkish reliability study of the Tampa Kinesiophobia Scale was conducted by Yılmaz et al. (2011)
Fear-Avoidance Beliefs Questionnaire
Time frame: 5 minute
Fear Avoidance Beliefs Questionnaire consists of 16 questions. It has two subscales: physical activity and work. The physical activity section consists of 5 questions and the work section consists of 11 questions. The questionnaire is a 7-point Likert type scale. The answers to the questionnaire are between strongly disagree (0 points) and strongly agree (6 points). Items 1, 8, 13, 14 and 16 are not included in the scoring. The Physical Activity section can receive a minimum of 0 and a maximum of 24 points. The labour section can score a minimum of 0 and a maximum of 42 points. As the total score approaches 0, it is accepted that there is a decrease in fear-avoidance behaviour within the section, and as it approaches the maximum score, it is accepted that there is an increase in fear-avoidance behaviour. The Turkish reliability and validity study of the Fear-Avoidance Beliefs Questionnaire was conducted by Bingül et al.
Roland-Morris Disability Questionnaire
Time frame: 5 minute
Roland Morris Disability Questionnaire was published by Roland and Morris in 1983 (Roland \& Fairbank, 2000). It consists of 24 questions about the person's perception of low back pain and related disability. It consists of physical ability/activity (15), sleep/rest (3), psychosocial (2), home management (2), eating (1) and pain frequency (1). Patients are asked to answer all questions 'yes/no'. Each 'yes' answer is scored as 1 and each 'no' answer is scored as 0. Total score for 24 questions is calculated. In this questionnaire, a high score indicates a bad score. The Turkish validation study of the Roland-Morris Disability Questionnaire was conducted by Küçükdeveci et al.
Beck Depression Scale
Time frame: 5 minute
The Beck Depression Scale is a self-report questionnaire that assesses the presence and severity of depressive symptoms. It consists of 21 items. Each item is scored on a four-point scale ranging from 0 (none) to 3 (severe). Total scores can vary between 0 and 63. The reliability and validity findings of the questionnaire adapted to Turkish have been obtained.
Self-Efficacy for Managing Chronic Disease 6-Item Scale
Time frame: 3 minute
Self-Efficacy for Managing Chronic Disease 6-Item Scale was developed by Lorig and colleagues in English in 2001 (Lorig, Sobel, Ritter, Laurent, \& Hobbs, 2001). The scale is graded on a 10-point scale ranging from 'not at all confident' to 'completely confident'. The scale score is the average of 6 items. High scores indicate high self-efficacy. If more than 1 response is given to an item and the items are consecutive, the low score is included in the calculation. If 2 responses are not consecutive, this item is excluded from the calculation. In order to calculate the scale, at least 4 items must be answered. The Turkish version is a valid and reliable tool for assessing the perceived self-efficacy level of patients with chronic diseases.
Coping Strategies Inventory Short Form (CSI-SF)
Time frame: 5 minute
Coping Strategies Long Form is the short form developed by Carver (1997) after being revised. Coping Strategies Inventory Short Form consists of 28 questions and 14 subscales. Responses to each item are evaluated in the range of 1-4 points. The raw score that can be obtained from the subscales varies between 2-8.
Pain Catastrophising Scale
Time frame: 5 minute
The Catastrophising Pain Scale (PCS) is used to measure catastrophising in response to pain through 13 statements with four possible options from 1 'never' to 4 'always'. Higher scores indicate greater catastrophised pain. The Turkish validity study of the scale was conducted by Süren et al. (2014)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 5 minute
PSQI is a scale developed to evaluate sleep quality and sleep disturbance in a one-month period. PSQI consists of 24 questions in total. The first 18 questions answered by the participant himself/herself are used in the calculation of the PSQI total score and component scores. The 18 items included in the scoring are grouped into 7 components. Each item is evaluated in the range of 0-3 points. The sum of the seven component scores constitutes the result of the PSQI. The lowest score is zero and the highest score is 21. A high total score indicates poor sleep quality. The sleep quality of individuals with a total score of 5 and below is considered 'good', while the sleep quality of individuals with a score above 5 is considered 'poor'. The validity and reliability study of the PSQI was conducted by Agargun et al. (1996) in our country.
Short Form - 36 Quality of Life Questionnaire (SF-36)
Time frame: 7 minute
The Short Form - 36 Quality of Life Questionnaire (SF-36) is a general measure of health status, rather than measuring the outcomes of specific conditions. There is evidence that the SF-36 can be used to monitor musculoskeletal conditions. The SF-36 is a health-related quality of life questionnaire consisting of 8 scales (physical functioning, role limitations due to physical health problems, pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, mental health). Responses to items are converted into scale scores from 0 (worst health) to 100 (best health). One physical and one mental summary health measure are derived from the 8 scales.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emrah Afsar, Phd principal investigator
Kutahya Health Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low-back Pain (cLBP), run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 1 minute). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.