AdaptationNCT06184776
'Lumbar Stiffness Disability Index' Turkish Adaptation
An observational study of Adaptation and Lumbar Stiffness, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial summary
Despite advancements in assessment and treatment methods, diagnosing and treating lower back pain remains challenging for researchers and clinicians. The literature doesn't support a definitive cause for the onset of back pain, as risk factors are diverse, population-specific, and inadequate when solely associated… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adaptation, Lumbar Stiffness
- What is being tested?
- Lumbar Stiffness Disability Index
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 1 Sep 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals who has non-specific low back pain
Who may be able to join
- Individuals whose native language is Turkish,
- Those who are literate,
- Who have signed the voluntary consent form, and
- Who have been experiencing non-specific lower back pain for at least 3 months
Who cannot join
- Participants who are pregnant,
- Those who have experienced acute trauma related to the lumbar region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 'Lumbar Stiffness Disability Index' Turkish Adaptation, Reliability and Validity Study
Despite advancements in assessment and treatment methods, diagnosing and treating lower back pain remains challenging for researchers and clinicians. The literature doesn't support a definitive cause for the onset of back pain, as risk factors are diverse, population-specific, and inadequate when solely associated with back pain. Evaluating spinal stiffness is crucial, as it can either cause or result from back pain. However, assessing spinal stiffness lacks standardized and reliable methods, and studies regarding its relation to pain and movement are insufficient.
The measurement principles and optimization techniques for assessing spinal stiffness haven't been fully explained or practically recommended. Creating a practical diagnostic process involving examination procedures, a diagnostic checklist, and practical indices for evidence in clinical assessments is crucial. Early identification of individuals at risk of prolonged disability and illness is vital since specific interventions can be developed in the early stages.
The Lumbar Stiffness Disability Index (LSDI) stands out among valid and reliable tools for assessing lumbar stiffness and disability. It is an index designed in English, translated into languages like Chinese and Japanese, proving to be a useful tool to describe a patient's condition based on pain, function, and disability, tracking changes throughout treatment.
Read the detailed description
Back pain is typically described as localized stiffness, often associated with muscle tension or in the lower border of the ribs and upper gluteal region, radiating or non-radiating to the leg. Back pain can be acute, subacute, or chronic, classified as such if it lasts less than six weeks, between six weeks and three months, or more than three months, respectively. Chronic back pain, especially, exhibits a high prevalence and continues to rise with industrialization, peaking in the 50-55 age group, with a notable increase in prevalence after the age of 80. It is more common in women. According to 2020 data from the World Health Organization, back pain has affected 619 million people globally, with an estimated increase to 843 million by 2050 due to population growth and aging. Back pain affects individuals of all age groups and is a leading cause of disability worldwide, imposing a significant financial burden on patients. Non-specific back pain accounts for approximately 90% of all cases.
Non-specific back pain poses a significant public health issue, lacking a sufficiently reliable and valid classification system for diagnosis in the literature. Imaging methods have limited effectiveness in diagnosis, as individuals with chronic back pain often present non-specific findings in imaging studies. Even asymptomatic patients frequently exhibit abnormal findings. Despite advancements in assessment and treatment methods, diagnosing and treating back pain remains challenging for both researchers and clinicians. The literature does not support a specific cause for the onset of back pain, as risk factors are diverse, population-specific, and associating back pain alone is inadequate.
Spinal segmental stiffness can either cause or result from back pain and is widely assessed in clinical and research settings. Despite frequent use of manual techniques in clinical assessments, the reliability of spinal stiffness assessment is weak, and studies on its relationship with pain and movement are insufficient. Existing reviews have not fully explained the principles of measurement methods for spinal stiffness or provided practical recommendations for optimizing measurements. To demonstrate evidence in clinical assessments, a practical diagnostic process involving examination procedures and a diagnostic checklist with a specific index is crucial. Early identification of individuals at risk of prolonged disability and illness is essential, as specific interventions can be developed in the early stages. Improvement becomes more challenging as symptoms persist and the condition becomes chronic.
When examining the literature, the Lumbar Stiffness Disability Index (LSDI) stands out among valid and reliable assessment tools for evaluating lumbar stiffness. Developed in English, translated into languages such as Chinese and Japanese, the LSDI is becoming widely recognized as a useful index for assessing lumbar spine rigidity and flexibility. The creation of a Turkish version of this index is considered valuable for clinical use.
- Conditions
- Adaptation, Lumbar Stiffness
- Being tested
- Lumbar Stiffness Disability Index
- Keywords
- Adaptation, Reliability, Validity, Assessment, Lumbar Stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Stiffness Disability IndexOther
Also called Oswestry Disability Index, Functional Reach Test, Goniometric Measurements of Lumbar Region, Trunk Flexion and Hamstring Length Flexibility Test
The development and evaluation of the Turkish version of the Lumbar Stiffness Disability Index (LSDI) are planned. After ensuring the eligibility of adult participants included in the study, language validity will be established for the Turkish version of LSDI, and internal consistency will be assessed using Cronbach's alpha coefficient. Additionally, the test-retest reliability of the index will be evaluated by reapplying it to participants with a one-week interval. For external structure validity, LSDI scores will be correlated with Oswestry Disability Index, Functional Reach Test, and goniometric measurements. The study will include demographic data and measurements to examine the eligibility of individuals with specific medical conditions for the intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar Stiffness Disability Index
'Lumbar Stiffness Disability Index,' was developed by Hart et al. in 2013. It comprises 10 items and aims to assess the degree of impairment in the performance of daily activities due to the lack of mobility in individuals with compromised or lost lumbar spine flexibility. It queries the degree of execution of 10 movements related to the lumbar region in daily life, scored between 0 and 40, where a higher score indicates a higher level of disability (loss of ability). It can also be converted into a 100-point version. Developed as a 5-point Likert scale, it ranges from 0, indicating no impact and the activity being entirely achievable, to 4, meaning the activity is almost impossible to perform. Participants are asked to mark the value that is suitable for them in each activity.
Measured: Baseline
Secondary outcomes (5)
Oswestry Disability Index
The Oswestry Disability Index measures daily life activities from 10 different perspectives, including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual activity, social life, travel, and the varying degrees of pain. Each section contains 6 questions, and each question is scored between 0 and 5. The total score ranges from 0 to 50 and can be scaled to 100. This form is the most commonly used questionnaire for assessing disability due to back pain. Its validity and reliability have been demonstrated in the Turkish population, with a reported high level of internal consistency.
Measured: Baseline
Functional Reach Test
It is used to assess the flexibility of the lumbar region while the participant is standing. The participant stands sideways to the wall, with the arm on the wall without touching it, shoulder in 90 degrees of flexion, elbow in extension, and the hand clenched into a fist. Meanwhile, the 3rd metacarpal head is placed against the wall at shoulder height, and the participant is expected to reach as far as possible. The changing 3rd metacarpal head is measured with a ruler. The distance between the starting and ending positions is calculated to obtain a score. Care should be taken to ensure that the participant's heels do not lift off the ground during forward bending. A reaching distance between 15-18 cm indicates limited functional balance, while a reaching distance of 25 cm and above indicates sufficient balance capacity. The testing will be repeated three times, and the average of the last two assessments will be used. 15-second breaks will be given between each repetition.
Measured: Baseline
Goniometric Measurements of Lumbar Region
Goniometric measurements will be performed with a 360ᵒ universal goniometer. To ensure the smoothness of the measurement, the joint movement will be demonstrated to the participant beforehand. During the measurement, attention will be paid to the position of the pivot point, the moving arm, and the fixed arm. In the measurement of flexion and extension of the trunk, the lateral projection of the lumbosacral joint will be taken as the pivot point, and the fixed arm will be kept perpendicular to the ground, while the moving arm will follow the axillary midline. For the measurement of right and left lateral flexion, the 1st sacral spinous process will be considered as the pivot point, and the fixed arm will be kept perpendicular to the ground, while the moving arm will follow parallel to the 7th cervical spinous process.
Measured: Baseline
Trunk Flexion and Hamstring Length Flexibility Test
The participant stands on a 15 cm block. They attempt to bend forward and touch their toes without bending their knees. The distance between the fingertip (distal end of the 3rd phalanx) and the block is measured. A positive value is recorded if it is below the block, and a negative value is recorded if it is above the block.
Measured: Baseline
Trunk Lateral Flexion Flexibility Test
The participant stands with feet shoulder-width apart, arms by their side, in a standing position. The distal end of the 3rd phalanx of the hands is marked on the thigh. Subsequently, while flexing the trunk to the side (without leaning forward or backward), they are asked to slide their hand on the thigh. The point reached is marked, and the distance between the starting position and the marked point is measured.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Mar 2024
- Primary completion1 Jun 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdaptationStudies 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
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Elcin Dereli, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184776
- Sponsor's protocol ID
- IstanbulBU1
- Status last verified
- Oct 2024
- First submitted
- 15 Dec 2023
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Lumbar Stiffness Disability Index' Turkish Adaptation, Reliability and Validity Study
- ClinicalTrials.gov ID
- NCT06184776
- Acronym / sponsor ID
- IstanbulBU1
- Conditions
- Adaptation, Lumbar Stiffness
- Keywords
- Adaptation, Reliability, Validity, Assessment, Lumbar Stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 28 Dec 2023 (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.
Despite advancements in assessment and treatment methods, diagnosing and treating lower back pain remains challenging for researchers and clinicians. The literature doesn't support a definitive cause for the onset of back pain, as risk factors are diverse, population-specific, and inadequate when solely associated with back pain. Evaluating spinal stiffness is crucial, as it can either cause or result from back pain. However, assessing spinal stiffness lacks standardized and reliable methods, and studies regarding its relation to pain and movement are insufficient.
The measurement principles and optimization techniques for assessing spinal stiffness haven't been fully explained or practically recommended. Creating a practical diagnostic process involving examination procedures, a diagnostic checklist, and practical indices for evidence in clinical assessments is crucial. Early identification of individuals at risk of prolonged disability and illness is vital since specific interventions can be developed in the early stages.
The Lumbar Stiffness Disability Index (LSDI) stands out among valid and reliable tools for assessing lumbar stiffness and disability. It is an index designed in English, translated into languages like Chinese and Japanese, proving to be a useful tool to describe a patient's condition based on pain, function, and disability, tracking changes throughout treatment.
Detailed description
Back pain is typically described as localized stiffness, often associated with muscle tension or in the lower border of the ribs and upper gluteal region, radiating or non-radiating to the leg. Back pain can be acute, subacute, or chronic, classified as such if it lasts less than six weeks, between six weeks and three months, or more than three months, respectively. Chronic back pain, especially, exhibits a high prevalence and continues to rise with industrialization, peaking in the 50-55 age group, with a notable increase in prevalence after the age of 80. It is more common in women. According to 2020 data from the World Health Organization, back pain has affected 619 million people globally, with an estimated increase to 843 million by 2050 due to population growth and aging. Back pain affects individuals of all age groups and is a leading cause of disability worldwide, imposing a significant financial burden on patients. Non-specific back pain accounts for approximately 90% of all cases.
Non-specific back pain poses a significant public health issue, lacking a sufficiently reliable and valid classification system for diagnosis in the literature. Imaging methods have limited effectiveness in diagnosis, as individuals with chronic back pain often present non-specific findings in imaging studies. Even asymptomatic patients frequently exhibit abnormal findings. Despite advancements in assessment and treatment methods, diagnosing and treating back pain remains challenging for both researchers and clinicians. The literature does not support a specific cause for the onset of back pain, as risk factors are diverse, population-specific, and associating back pain alone is inadequate.
Spinal segmental stiffness can either cause or result from back pain and is widely assessed in clinical and research settings. Despite frequent use of manual techniques in clinical assessments, the reliability of spinal stiffness assessment is weak, and studies on its relationship with pain and movement are insufficient. Existing reviews have not fully explained the principles of measurement methods for spinal stiffness or provided practical recommendations for optimizing measurements. To demonstrate evidence in clinical assessments, a practical diagnostic process involving examination procedures and a diagnostic checklist with a specific index is crucial. Early identification of individuals at risk of prolonged disability and illness is essential, as specific interventions can be developed in the early stages. Improvement becomes more challenging as symptoms persist and the condition becomes chronic.
When examining the literature, the Lumbar Stiffness Disability Index (LSDI) stands out among valid and reliable assessment tools for evaluating lumbar stiffness. Developed in English, translated into languages such as Chinese and Japanese, the LSDI is becoming widely recognized as a useful index for assessing lumbar spine rigidity and flexibility. The creation of a Turkish version of this index is considered valuable for clinical use.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who has non-specific low back pain
Key inclusion criteria (4 listed)
- Individuals whose native language is Turkish,
- Those who are literate,
- Who have signed the voluntary consent form, and
- Who have been experiencing non-specific lower back pain for at least 3 months
Key exclusion criteria (2 listed)
- Participants who are pregnant,
- Those who have experienced acute trauma related to the lumbar region
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 |
|---|---|---|
| Lumbar Stiffness Disability IndexAlso: Oswestry Disability Index, Functional Reach Test, Goniometric Measurements of Lumbar Region, Trunk Flexion and Hamstring Length Flexibility TestThe development and evaluation of the Turkish version of the Lumbar Stiffness Disability Index (LSDI) are planned. After ensuring the eligibility of adult participants included in the study, language validity will be established for the Turkish version of LSDI, and internal consistency will be assessed using Cronbach's alpha coefficient. Additionally, the test-retest reliability of the index will be evaluated by reapplying it to participants with a one-week interval. For external structure validity, LSDI scores will be correlated with Oswestry Disability Index, Functional Reach Test, and goniometric measurements. The study will include demographic data and measurements to examine the eligibility of individuals with specific medical conditions for the intervention. | Other | – |
Primary outcome
Lumbar Stiffness Disability Index
Time frame: Baseline
'Lumbar Stiffness Disability Index,' was developed by Hart et al. in 2013. It comprises 10 items and aims to assess the degree of impairment in the performance of daily activities due to the lack of mobility in individuals with compromised or lost lumbar spine flexibility. It queries the degree of execution of 10 movements related to the lumbar region in daily life, scored between 0 and 40, where a higher score indicates a higher level of disability (loss of ability). It can also be converted into a 100-point version. Developed as a 5-point Likert scale, it ranges from 0, indicating no impact and the activity being entirely achievable, to 4, meaning the activity is almost impossible to perform. Participants are asked to mark the value that is suitable for them in each activity.
5 secondary outcomes
Oswestry Disability Index
Time frame: Baseline
Functional Reach Test
Time frame: Baseline
Goniometric Measurements of Lumbar Region
Time frame: Baseline
Trunk Flexion and Hamstring Length Flexibility Test
Time frame: Baseline
Trunk Lateral Flexion Flexibility Test
Time frame: Baseline
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 23 Oct 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Adaptation
Active, not recruiting
Improving Emotional Wellbeing of University Students: Emotion Regulation
Emotion Regulation
Not yet recruiting
Cerebello-Cortical Connectivity and Balance Adaptation in Younger and Older Adults
Aging, Postural Balance
Active, not recruiting
Improving Emotional Wellbeing of University Students: Anxiety Management
Anxiety
RecruitingPhase 3
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8
Recruiting
Structural Heat Adaptation and Education in Urban Setting
Heat Illness, Quality of Life
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Adaptation and Lumbar Stiffness, run by Istanbul Bilgi 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 4 inclusion and 2 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 23 Oct 2024. 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?
Lumbar Stiffness Disability Index (time frame: Baseline). 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 23 Oct 2024.