NCT06184776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 28, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

December 15, 2023

Last Update Submit

October 21, 2024

Conditions

Keywords

AdaptationReliabilityValidityAssessmentLumbar Stiffness

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (5)

  • Oswestry Disability Index

    Baseline

  • Functional Reach Test

    Baseline

  • Goniometric Measurements of Lumbar Region

    Baseline

  • Trunk Flexion and Hamstring Length Flexibility Test

    Baseline

  • Trunk Lateral Flexion Flexibility Test

    Baseline

Interventions

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.

Also known as: Oswestry Disability Index, Functional Reach Test, Goniometric Measurements of Lumbar Region, Trunk Flexion and Hamstring Length Flexibility Test, Trunk Lateral Flexion Flexibility Test

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals who has non-specific low back pain

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Bilgi University

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 15, 2023

First Posted

December 28, 2023

Study Start

March 1, 2024

Primary Completion

June 1, 2024

Study Completion

September 1, 2024

Last Updated

October 23, 2024

Record last verified: 2024-10

Locations