Disc HerniationFAB-LDHNCT07674407
Fear-Avoidance Beliefs and Physical Function in Patients With Lumbar Disc Herniation
An observational study of Disc Herniation, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Lumbar disc herniation is one of the most common causes of low back pain and is associated with substantial functional limitations and reduced quality of life, particularly among working-age individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Disc Herniation
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2026to 30 Oct 2026
- How long will I take part?
- 1 Day
- 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 65 years
- All sexes
- Adult, Older adult
Study population: The study will include volunteer individuals aged 18-65 who applied to a physiotherapy and rehabilitation clinic and were diagnosed with lumbar disc herniation.
Who may be able to join
- Aged between 18 and 65 years
- Clinically and/or radiologically diagnosed with lumbar disc herniation
- Presence of low back pain for at least 3 months
- Sufficient cognitive capacity to understand and perform the assessment procedures
- Ability to walk independently
- Willingness to participate voluntarily and provide written informed consent
Who cannot join
- History of lumbar spine surgery
- History of neurological disorders, such as stroke or Parkinson's disease
- Vestibular disorders or severe balance impairment
- History of orthopedic injury or surgery affecting the lower extremities
- Presence of rheumatological disease
- Pregnancy
- Severe pain or an acute inflammatory condition that prevents completion of the assessment procedures
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
Istinye University
Istanbul, 34010
Kubra Kardes, Asst.Prof, 05387115631, kubrakoce@gmail.com
Kubra Kardes, Asst. Prof.
About this study
Official title: The Relationship Between Fear-Avoidance Beliefs and Trunk Muscle Endurance, Balance, and Functional Impairment in Patients With Lumbar Disc Herniation
Lumbar disc herniation is one of the most common causes of low back pain and is associated with substantial functional limitations and reduced quality of life, particularly among working-age individuals. Displacement of disc material toward the spinal canal may result in mechanical compression and inflammation of the nerve roots, leading to pain, restricted movement, and reduced functional performance.
The course of low back pain cannot be explained solely by biomechanical and anatomical factors. Psychosocial factors also play an important role in symptom persistence and functional outcomes. Within this context, the fear-avoidance model provides an important theoretical framework, suggesting that individuals may develop fear of movement and avoid physical activities because they believe these activities may increase pain or cause further injury. Over time, avoidance behaviors may contribute to physical deconditioning, reduced muscle function, and increased functional impairment.
Read more
The Fear-Avoidance Beliefs Questionnaire is commonly used to assess individuals' beliefs regarding the relationship between pain, physical activity, and work-related activities. Higher levels of fear-avoidance beliefs have been associated with greater pain severity, increased disability, and poorer physical performance in individuals with low back pain.
Trunk muscle endurance plays a key role in maintaining spinal stability. Adequate endurance of the paraspinal and abdominal muscles supports mechanical stability of the spine and contributes to the safe performance of functional movements. The Biering-Sørensen Test and plank test are commonly used to assess trunk muscle endurance in clinical and research settings. The Biering-Sørensen Test evaluates the endurance of the trunk extensor muscles, whereas plank-based tests assess the endurance of the anterior and lateral trunk musculature.
Functional impairment in individuals with low back pain can be evaluated using the Oswestry Disability Index, a self-reported questionnaire that assesses limitations experienced during activities of daily living. Functional mobility and performance may also be evaluated using the Timed Up and Go test, which involves standing up from a chair, walking a short distance, turning, returning to the chair, and sitting down. This test reflects mobility, dynamic balance, and functional performance during daily activities.
Postural control and balance may also be affected in individuals with low back pain. Reduced static balance performance can negatively influence functional activities and mobility. The Single-Leg Stance Test is a practical clinical measure used to assess postural stability and static balance.
Although previous studies have examined associations between psychosocial factors and functional status in individuals with low back pain, studies evaluating the relationship between fear-avoidance beliefs, trunk muscle endurance, balance, and functional performance together remain limited. Identifying these relationships may contribute to the development of more comprehensive rehabilitation programs for individuals with lumbar disc herniation.
- Conditions
- Disc Herniation
- Keywords
- fear-avoidance beliefs, trunk muscle endurance, balance, functional impairment, low back pain
- Medical subject headings
- Intervertebral Disc Displacement, Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear-Avoidance Beliefs
Fear-avoidance beliefs related to pain will be assessed using the Fear-Avoidance Beliefs Questionnaire. The Fear-Avoidance Beliefs Questionnaire is a self-reported questionnaire that evaluates individuals' fear-avoidance beliefs regarding pain in relation to physical activity and work-related activities. The questionnaire consists of 16 items and includes two subscales: the Physical Activity subscale and the Work subscale. Participants rate each statement on a Likert-type scale ranging from 0 (completely disagree) to 6 (completely agree). Higher scores indicate stronger fear-avoidance beliefs, suggesting greater concern that physical activity or work-related activities may worsen pain or cause further injury. Lower scores indicate fewer fear-avoidance beliefs and less perceived threat associated with movement and activity.
Measured: 4 weeks
Lumbar Extensor Muscle Endurance
Lumbar extensor muscle endurance will be assessed using the Biering-Sørensen Test. During the test, participants will be positioned prone on a treatment table, with the pelvis and lower extremities stabilized. Participants will be instructed to maintain their upper body in a horizontal position with the trunk extending beyond the edge of the table. The duration for which the participant maintains this position will be recorded in seconds using a stopwatch. The test will be terminated if the participant is unable to maintain the required position, demonstrates a loss of alignment, or wishes to stop the test. A longer holding time indicates greater lumbar extensor muscle endurance, whereas a shorter holding time indicates reduced lumbar extensor muscle endurance.
Measured: 4 weeks
Abdominal Muscle Endurance
Abdominal muscle endurance will be assessed using the plank test. Participants will assume a prone plank position with the elbows positioned under the shoulders and the toes in contact with the floor. They will be instructed to maintain the trunk in a straight line. The duration for which the position is maintained will be recorded in seconds using a stopwatch. The test will be terminated if trunk alignment is lost or if the participant is unable to continue. A longer holding time indicates greater abdominal muscle endurance and trunk stabilization capacity, whereas a shorter holding time indicates reduced abdominal muscle endurance.
Measured: 4 weeks
Assessment of Functional Impairment
Functional impairment in activities of daily living will be assessed using the Oswestry Disability Index. The Oswestry Disability Index is a self-reported questionnaire that evaluates the impact of low back pain on daily activities. It consists of 10 sections, each containing six response options that reflect the individual's functional status during daily activities. Each section is scored from 0 to 5, and the total score is calculated as a percentage. Higher Oswestry Disability Index scores indicate greater functional impairment and disability related to low back pain, whereas lower scores indicate less functional impairment and better functional status.
Measured: 4 weeks
Assessment of Functional Performance
Functional mobility and performance will be assessed using the Timed Up and Go test. Participants will begin in a seated position in a standard chair. Upon instruction, participants will stand up, walk three meters to a designated point, turn around, walk back to the chair, and sit down. The completion time will be measured in seconds using a stopwatch. A shorter completion time indicates better functional mobility, dynamic balance, and walking performance, whereas a longer completion time indicates reduced functional mobility and performance.
Measured: 4 weeks
Assessment of Balance Performance
Static balance performance will be assessed using the Single-Leg Stance Test. Participants will be instructed to stand on one leg with their arms positioned alongside the body. The duration for which they are able to maintain balance while keeping the opposite foot off the floor will be recorded in seconds using a stopwatch. The test will be terminated if the raised foot touches the floor, the stance foot changes position, or balance is lost. The test may be performed on both the right and left legs, and the holding times will be recorded separately. A longer standing time indicates better static balance and postural stability, whereas a shorter standing time indicates reduced static balance performance.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start30 Jun 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc HerniationStudies of the same condition, open and under way.
- More trials run by Istinye 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Issa, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674407
- Sponsor's protocol ID
- IstinyeU2333095101
- Acronym
- FAB-LDH
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2026
- Last updated
- 11 Aug 2026
- 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 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Fear-Avoidance Beliefs and Trunk Muscle Endurance, Balance, and Functional Impairment in Patients With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT07674407
- Acronym / sponsor ID
- FAB-LDH / IstinyeU2333095101
- Conditions
- Disc Herniation
- Keywords
- fear-avoidance beliefs, trunk muscle endurance, balance, functional impairment, low back pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 29 Jun 2026 (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.
Lumbar disc herniation is one of the most common causes of low back pain and is associated with substantial functional limitations and reduced quality of life, particularly among working-age individuals. Displacement of disc material toward the spinal canal may result in mechanical compression and inflammation of the nerve roots, leading to pain, restricted movement, and reduced functional performance.
The course of low back pain cannot be explained solely by biomechanical and anatomical factors. Psychosocial factors also play an important role in symptom persistence and functional outcomes. Within this context, the fear-avoidance model provides an important theoretical framework, suggesting that individuals may develop fear of movement and avoid physical activities because they believe these activities may increase pain or cause further injury. Over time, avoidance behaviors may contribute to physical deconditioning, reduced muscle function, and increased functional impairment.
The Fear-Avoidance Beliefs Questionnaire is commonly used to assess individuals' beliefs regarding the relationship between pain, physical activity, and work-related activities. Higher levels of fear-avoidance beliefs have been associated with greater pain severity, increased disability, and poorer physical performance in individuals with low back pain.
Trunk muscle endurance plays a key role in maintaining spinal stability. Adequate endurance of the paraspinal and abdominal muscles supports mechanical stability of the spine and contributes to the safe performance of functional movements. The Biering-Sørensen Test and plank test are commonly used to assess trunk muscle endurance in clinical and research settings. The Biering-Sørensen Test evaluates the endurance of the trunk extensor muscles, whereas plank-based tests assess the endurance of the anterior and lateral trunk musculature.
Functional impairment in individuals with low back pain can be evaluated using the Oswestry Disability Index, a self-reported questionnaire that assesses limitations experienced during activities of daily living. Functional mobility and performance may also be evaluated using the Timed Up and Go test, which involves standing up from a chair, walking a short distance, turning, returning to the chair, and sitting down. This test reflects mobility, dynamic balance, and functional performance during daily activities.
Postural control and balance may also be affected in individuals with low back pain. Reduced static balance performance can negatively influence functional activities and mobility. The Single-Leg Stance Test is a practical clinical measure used to assess postural stability and static balance.
Although previous studies have examined associations between psychosocial factors and functional status in individuals with low back pain, studies evaluating the relationship between fear-avoidance beliefs, trunk muscle endurance, balance, and functional performance together remain limited. Identifying these relationships may contribute to the development of more comprehensive rehabilitation programs for individuals with lumbar disc herniation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will include volunteer individuals aged 18-65 who applied to a physiotherapy and rehabilitation clinic and were diagnosed with lumbar disc herniation.
Key inclusion criteria (6 listed)
- Aged between 18 and 65 years
- Clinically and/or radiologically diagnosed with lumbar disc herniation
- Presence of low back pain for at least 3 months
- Sufficient cognitive capacity to understand and perform the assessment procedures
- Ability to walk independently
Key exclusion criteria (7 listed)
- History of lumbar spine surgery
- History of neurological disorders, such as stroke or Parkinson's disease
- Vestibular disorders or severe balance impairment
- History of orthopedic injury or surgery affecting the lower extremities
- Presence of rheumatological 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
Fear-Avoidance Beliefs
Time frame: 4 weeks
Fear-avoidance beliefs related to pain will be assessed using the Fear-Avoidance Beliefs Questionnaire. The Fear-Avoidance Beliefs Questionnaire is a self-reported questionnaire that evaluates individuals' fear-avoidance beliefs regarding pain in relation to physical activity and work-related activities. The questionnaire consists of 16 items and includes two subscales: the Physical Activity subscale and the Work subscale. Participants rate each statement on a Likert-type scale ranging from 0 (completely disagree) to 6 (completely agree). Higher scores indicate stronger fear-avoidance beliefs, suggesting greater concern that physical activity or work-related activities may worsen pain or cause further injury. Lower scores indicate fewer fear-avoidance beliefs and less perceived threat associated with movement and activity.
Lumbar Extensor Muscle Endurance
Time frame: 4 weeks
Lumbar extensor muscle endurance will be assessed using the Biering-Sørensen Test. During the test, participants will be positioned prone on a treatment table, with the pelvis and lower extremities stabilized. Participants will be instructed to maintain their upper body in a horizontal position with the trunk extending beyond the edge of the table. The duration for which the participant maintains this position will be recorded in seconds using a stopwatch. The test will be terminated if the participant is unable to maintain the required position, demonstrates a loss of alignment, or wishes to stop the test. A longer holding time indicates greater lumbar extensor muscle endurance, whereas a shorter holding time indicates reduced lumbar extensor muscle endurance.
Abdominal Muscle Endurance
Time frame: 4 weeks
Abdominal muscle endurance will be assessed using the plank test. Participants will assume a prone plank position with the elbows positioned under the shoulders and the toes in contact with the floor. They will be instructed to maintain the trunk in a straight line. The duration for which the position is maintained will be recorded in seconds using a stopwatch. The test will be terminated if trunk alignment is lost or if the participant is unable to continue. A longer holding time indicates greater abdominal muscle endurance and trunk stabilization capacity, whereas a shorter holding time indicates reduced abdominal muscle endurance.
Assessment of Functional Impairment
Time frame: 4 weeks
Functional impairment in activities of daily living will be assessed using the Oswestry Disability Index. The Oswestry Disability Index is a self-reported questionnaire that evaluates the impact of low back pain on daily activities. It consists of 10 sections, each containing six response options that reflect the individual's functional status during daily activities. Each section is scored from 0 to 5, and the total score is calculated as a percentage. Higher Oswestry Disability Index scores indicate greater functional impairment and disability related to low back pain, whereas lower scores indicate less functional impairment and better functional status.
Assessment of Functional Performance
Time frame: 4 weeks
Functional mobility and performance will be assessed using the Timed Up and Go test. Participants will begin in a seated position in a standard chair. Upon instruction, participants will stand up, walk three meters to a designated point, turn around, walk back to the chair, and sit down. The completion time will be measured in seconds using a stopwatch. A shorter completion time indicates better functional mobility, dynamic balance, and walking performance, whereas a longer completion time indicates reduced functional mobility and performance.
Assessment of Balance Performance
Time frame: 4 weeks
Static balance performance will be assessed using the Single-Leg Stance Test. Participants will be instructed to stand on one leg with their arms positioned alongside the body. The duration for which they are able to maintain balance while keeping the opposite foot off the floor will be recorded in seconds using a stopwatch. The test will be terminated if the raised foot touches the floor, the stance foot changes position, or balance is lost. The test may be performed on both the right and left legs, and the holding times will be recorded separately. A longer standing time indicates better static balance and postural stability, whereas a shorter standing time indicates reduced static balance performance.
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 Aug 2026.
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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 Disc Herniation, run by Istinye 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 6 inclusion and 7 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 Aug 2026. 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 Kubra Kardes (05387115631, kubrakoce@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear-Avoidance Beliefs (time frame: 4 weeks). The study lists 6 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 Aug 2026.