Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06184776 |
Other study ID # |
IstanbulBU1 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 2024 |
Est. completion date |
September 2024 |
Study information
Verified date |
March 2024 |
Source |
Istanbul Bilgi University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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 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.
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.