Clinical trial NCT06184776: 'Lumbar Stiffness Disability Index' Turkish Adaptation
Official title: 'Lumbar Stiffness Disability Index' Turkish Adaptation, Reliability and Validity Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adaptation
Lumbar Stiffness
Keywords: Adaptation
Reliability
Validity
Assessment
Lumbar Stiffness
Lead sponsor: Istanbul Bilgi University
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals who has non-specific low back pain

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Participants who are pregnant,
* Those who have experienced acute trauma related to the lumbar region

Primary outcomes:
measure: Lumbar Stiffness Disability Index
timeFrame: Baseline
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: Baseline
measure: Functional Reach Test
timeFrame: Baseline
measure: Goniometric Measurements of Lumbar Region
timeFrame: Baseline
measure: Trunk Flexion and Hamstring Length Flexibility Test
timeFrame: Baseline
measure: Trunk Lateral Flexion Flexibility Test
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Bilgi University
Study officials:
References: