Low Back PainNCT06869668
The Relationship Between Disability, Fear Avoidance Beliefs, Physical Performance and Quality of Life in Chronic Low Back Pain
An observational study of Low Back Pain and Chronic Low-back Pain (cLBP), run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the multidimensional profile of individuals with chronic low back pain (CLBP) and to determine the relationship between disability and fear avoidance beliefs, physical performance and quality of life in this population. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Low Back Pain, Chronic Low-back Pain (cLBP)
- What is being tested?
- Correlation
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2024to 1 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Chronic low back pain
Who may be able to join
- Back pain for at least 3 months
- Pain intensity ≥ 3 on the Visual Analog Scale
Who cannot join
- History of spinal surgery/trauma
- Other back pain (associated with rheumatic diseases, multiple sclerosis, malignancy, etc.) instability conditions such as spondylolysis and spondylolisthesis
- Pregnancy
- Obesity (BMI ≥ 30 kg/m²)
- Presence of orthopedic problems or chronic diseases that may interfere with testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa
Istanbul, Buyukcekmece, 34500
Tuğba Akgüller Eker, MSc, 0212 866 37 00, t.akguller09@gmail.com
About this study
The aim of this study was to determine the multidimensional profile of individuals with chronic low back pain (CLBP) and to determine the relationship between disability and fear avoidance beliefs, physical performance and quality of life in this population. Individuals with chronic low back pain between the ages of 18-50 will be included in the study. Disability level of the participants will be assessed with Oswestry Disability Index (ODI), fear avoidance attitudes with Avoidance Beliefs Questionnaire-Physical Activity (FABQ-PA), and quality of life with Short Form-12 (SF-12). Trunk endurance, functional mobility and static-dynamic balance will be assessed for physical performance. Trunk endurance will be assessed with McGill endurance tests, functional mobility with Timed Up and Go Test (TUG), dynamic balance with Y-balance test, and static balance with single leg stance test.
- Conditions
- Low Back Pain, Chronic Low-back Pain (cLBP)
- Being tested
- Correlation
- Keywords
- low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorrelationOther
Correlation between outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
The questionnaire assessing the level of disability associated with low back pain includes a total of 10 questions, and each question is scored from 0 to 5. The total score ranges from 0 to 100, with higher scores indicating higher levels of disability.
Measured: Day 1
Fear Avoidance Beliefs Questionnaire
The questionnaire, consisting of 16 items in total, has two subscales: work-related (FABQ-work) and physical activity-related (FABQ-PA). The physical activity-related subscale measures beliefs about how physical activity can affect a person's pain. The work-related subscale measures beliefs about how a person's work can affect their pain. The scale is calculated by summing the responses to all questions, with higher scores indicating higher levels of fear-avoidance beliefs.The FABQ-PA score will be used in the study.
Measured: Day 1
Short Form-12/SF-12
The questionnaire that evaluates the participants' health-related quality of life has two sub-scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). The PCS-12 score is obtained from the sub-dimensions of general health, physical functioning, physical role and body pain, while the PCS-12 score is obtained from the sub-dimensions of social functioning, emotional role, mental health and energy. Both the PCS-12 and PCS-12 scores range from 0 to 100, with higher scores representing better health.
Measured: Day 1
McGill Trunk Muscle Endurance Tests
Trunk flexor endurance test: The participant is positioned by the tester with the knees and hips at 90 degrees, the trunk at 60 degrees, the hands crossed on both shoulders and the soles of the feet flat on the floor.
Trunk extensor endurance test: Individuals are asked to hang their trunks from the bed starting from the spina iliaca anterior superior and cross both arms on the shoulders. The legs are fixed by the gastrocnemius muscle by the operator. When the individuals achieve a horizontal position, the test is started.
Lateral Trunk Endurance Test: The individual is positioned with their feet, right arms perpendicular to the floor, elbows on the mat, left arms at chest level and left hands on the right shoulder. The test period starts as soon as they lift their hips by supporting themselves with their elbows and feet on the floor.The same is repeated for the other side.
Measured: Day 1
Timed Up and Go Test (TUG)
A 3-meter area in front of the chair is determined. The patient is asked to get up from the chair, walk this distance, and sit down again. The elapsed time gives the result of the test and the time is recorded in seconds. The test is performed twice with a 1-minute interval and the average time is taken.
Measured: Day 1
Y balance test
The Y balance test is a simple and reliable test used to evaluate dynamic balance. In the Y balance test, the person's balance on 3 different lines (anterior-posterolateral-posteromedial) is evaluated separately for each leg. There is a 135° angle between the anterior line and each of the posterolateral/posteromedial directions, and a 90° angle between the posterolateral and posteromedial directions. In the Y balance test, the person is positioned in the exact center of these three lines without shoes. While the foot to be tested is in the center, the other foot extends on these three different lines. The last point that can be reached without losing balance is marked each time. Three attempts are given for each direction, and the average of these three distances is recorded.
Measured: Day 1
Single leg stance test
In the test performed for static balance assessment, the individual lifts one foot off the ground without support, with the hands on the hips. The time that the foot can be held in the air without losing balance is recorded. The test is stopped when the foot touches the ground or the hands leave the hips.
Measured: Day 1
Visual Analog Scale
This scale is a simple and reliable scale used to record the intensity of pain felt by patients. Participants are asked to mark the level of pain they feel on the VAS, which consists of a 10 cm horizontal line extending from 0 to 10. The value of "0" on the scale indicates no pain, and the value of "10" indicates the most severe pain.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start30 Nov 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Akgüller, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869668
- Sponsor's protocol ID
- takgullereker
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 11 Mar 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Disability, Fear Avoidance Beliefs, Physical Performance and Quality of Life in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06869668
- Acronym / sponsor ID
- takgullereker
- Conditions
- Low Back Pain, Chronic Low-back Pain (cLBP)
- Keywords
- low back pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 11 Mar 2025 (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 determine the multidimensional profile of individuals with chronic low back pain (CLBP) and to determine the relationship between disability and fear avoidance beliefs, physical performance and quality of life in this population. Individuals with chronic low back pain between the ages of 18-50 will be included in the study. Disability level of the participants will be assessed with Oswestry Disability Index (ODI), fear avoidance attitudes with Avoidance Beliefs Questionnaire-Physical Activity (FABQ-PA), and quality of life with Short Form-12 (SF-12). Trunk endurance, functional mobility and static-dynamic balance will be assessed for physical performance. Trunk endurance will be assessed with McGill endurance tests, functional mobility with Timed Up and Go Test (TUG), dynamic balance with Y-balance test, and static balance with single leg stance test.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Chronic low back pain
Key inclusion criteria (2 listed)
- Back pain for at least 3 months
- Pain intensity ≥ 3 on the Visual Analog Scale
Key exclusion criteria (5 listed)
- History of spinal surgery/trauma
- Other back pain (associated with rheumatic diseases, multiple sclerosis, malignancy, etc.) instability conditions such as spondylolysis and spondylolisthesis
- Pregnancy
- Obesity (BMI ≥ 30 kg/m²)
- Presence of orthopedic problems or chronic diseases that may interfere with testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorrelationCorrelation between outcomes | Other | – |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: Day 1
The questionnaire assessing the level of disability associated with low back pain includes a total of 10 questions, and each question is scored from 0 to 5. The total score ranges from 0 to 100, with higher scores indicating higher levels of disability.
Fear Avoidance Beliefs Questionnaire
Time frame: Day 1
The questionnaire, consisting of 16 items in total, has two subscales: work-related (FABQ-work) and physical activity-related (FABQ-PA). The physical activity-related subscale measures beliefs about how physical activity can affect a person's pain. The work-related subscale measures beliefs about how a person's work can affect their pain. The scale is calculated by summing the responses to all questions, with higher scores indicating higher levels of fear-avoidance beliefs.The FABQ-PA score will be used in the study.
Short Form-12/SF-12
Time frame: Day 1
The questionnaire that evaluates the participants' health-related quality of life has two sub-scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). The PCS-12 score is obtained from the sub-dimensions of general health, physical functioning, physical role and body pain, while the PCS-12 score is obtained from the sub-dimensions of social functioning, emotional role, mental health and energy. Both the PCS-12 and PCS-12 scores range from 0 to 100, with higher scores representing better health.
McGill Trunk Muscle Endurance Tests
Time frame: Day 1
Trunk flexor endurance test: The participant is positioned by the tester with the knees and hips at 90 degrees, the trunk at 60 degrees, the hands crossed on both shoulders and the soles of the feet flat on the floor. Trunk extensor endurance test: Individuals are asked to hang their trunks from the bed starting from the spina iliaca anterior superior and cross both arms on the shoulders. The legs are fixed by the gastrocnemius muscle by the operator. When the individuals achieve a horizontal position, the test is started. Lateral Trunk Endurance Test: The individual is positioned with their feet, right arms perpendicular to the floor, elbows on the mat, left arms at chest level and left hands on the right shoulder. The test period starts as soon as they lift their hips by supporting themselves with their elbows and feet on the floor.The same is repeated for the other side.
Timed Up and Go Test (TUG)
Time frame: Day 1
A 3-meter area in front of the chair is determined. The patient is asked to get up from the chair, walk this distance, and sit down again. The elapsed time gives the result of the test and the time is recorded in seconds. The test is performed twice with a 1-minute interval and the average time is taken.
Y balance test
Time frame: Day 1
The Y balance test is a simple and reliable test used to evaluate dynamic balance. In the Y balance test, the person's balance on 3 different lines (anterior-posterolateral-posteromedial) is evaluated separately for each leg. There is a 135° angle between the anterior line and each of the posterolateral/posteromedial directions, and a 90° angle between the posterolateral and posteromedial directions. In the Y balance test, the person is positioned in the exact center of these three lines without shoes. While the foot to be tested is in the center, the other foot extends on these three different lines. The last point that can be reached without losing balance is marked each time. Three attempts are given for each direction, and the average of these three distances is recorded.
Single leg stance test
Time frame: Day 1
In the test performed for static balance assessment, the individual lifts one foot off the ground without support, with the hands on the hips. The time that the foot can be held in the air without losing balance is recorded. The test is stopped when the foot touches the ground or the hands leave the hips.
Visual Analog Scale
Time frame: Day 1
This scale is a simple and reliable scale used to record the intensity of pain felt by patients. Participants are asked to mark the level of pain they feel on the VAS, which consists of a 10 cm horizontal line extending from 0 to 10. The value of "0" on the scale indicates no pain, and the value of "10" indicates the most severe pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 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.
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 Low Back Pain and Chronic Low-back Pain (cLBP), run by Istanbul Arel 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuğba Akgüller Eker, MSc ((0212) 866 37 00, t.akguller09@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) (time frame: Day 1). The study lists 8 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 11 Mar 2025.