- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07417345
Biomechanical Gait Analysis in Low Back Pain (LBP)
Biomechanical Analysis of Gait in Individuals With Low Back Pain
The goal of this observational case-control study is to learn whether low back pain is associated with changes in gait and related clinical characteristics in adults over 18 years old. The main questions it aims to answer are:
- Are gait biomechanics different in people with low back pain compared with people without low back pain?
- Are pain intensity, psychosocial risk, and physical activity levels different between both groups? Participants will complete questionnaires about low back pain, physical activity, and health status, and will perform a walking test in a motion analysis laboratory where gait parameters are recorded.
Study Overview
Status
Conditions
Detailed Description
This study is an observational case-control investigation designed to explore the relationship between low back pain and gait biomechanics in adults. Low back pain is a common health problem that may affect movement patterns, physical function, and daily activities. Understanding how gait is modified in people with low back pain may help to improve assessment and rehabilitation strategies.
Participants will be divided into two groups: adults with low back pain and adults without low back pain. Sociodemographic and clinical characteristics will be collected to describe the sample and to allow comparisons between groups. The study will focus on the analysis of spatiotemporal, kinematic, and dynamic gait parameters obtained in a motion analysis laboratory.
Gait assessment will be performed using a three-dimensional motion capture system. In addition to gait analysis, participants will provide information about their health status, pain characteristics, physical activity, and psychosocial factors through self-report questionnaires. These variables will be used to describe the clinical profile of the participants and to examine potential associations with gait outcomes.
Comparisons between the low back pain group and the control group will be conducted to identify differences in gait biomechanics and clinical characteristics.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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León
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Ponferrada, León, Spain, 24401
- University of León - ULE MotionLab, Ponferrada Campus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 years or older.
- Ability to read and understand Spanish.
- For the low back pain group: current low back pain or low back pain within the last month lasting at least 24 hours.
- For the control group: absence of current low back pain and no episode of low back pain during the previous month.
- Willingness to participate and provision of written informed consent.
Exclusion Criteria:
- Presence of leg pain or radicular symptoms (sciatica).
- Pregnancy or childbirth within the last 12 months.
- Previous lumbar spine surgery.
- History of cancer, spinal tumor, or spinal infection.
- Vertebral compression fracture.
- Central nervous system disease.
- Cauda equina syndrome.
- Abdominal aortic aneurysm.
- Any surgery or traumatic injury of the lower limbs within the last 5 years.
- Any medical condition that could affect gait performance.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Low Back Pain Group
Adults over 18 years with current or recent low back pain without leg pain, who undergo clinical assessment and gait analysis in a motion laboratory.
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Control Group
Adults over 18 years without low back pain who undergo the same clinical assessment and gait analysis as the low back pain group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Gait speed
Time Frame: At baseline assessment
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Mean walking speed during gait measured in meters per second (m/s) using 3D motion analysis.
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At baseline assessment
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Step and stride length
Time Frame: Baseline
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Step length and stride length measured in meters (m) during gait analysis
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Baseline
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Cadence
Time Frame: Baseline
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Number of steps per minute during walking recorded with motion capture system (steps/min)
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Baseline
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Temporal gait parameters
Time Frame: Baseline
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Stance time and gait cycle time measured in seconds during gait
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Baseline
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Pelvis kinematics
Time Frame: Baseline
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Pelvic angles during gait in sagittal, frontal, and transverse planes, reported as maximum angle, minimum angle, and range of motion (ROM calculated as max-min).
Measured in degrees.
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Baseline
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Hip kinematics
Time Frame: Baseline
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Hip joint angles during gait in sagittal, frontal, and transverse planes, reported as maximum angle, minimum angle, and range of motion (ROM = max-min).
Measured in degrees.
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Baseline
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Knee kinematics
Time Frame: Baseline
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Knee joint angles during gait in sagittal, frontal, and transverse planes, reported as maximum angle, minimum angle, and range of motion (ROM = max-min).
Measured in degrees.
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Baseline
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Ankle kinematics
Time Frame: Baseline
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Ankle joint angles during gait in sagittal, frontal, and transverse planes, reported as maximum angle, minimum angle, and range of motion (ROM = max-min).
Measured in degrees.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain intensity - Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline
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Pain intensity measured with the Numeric Pain Rating Scale (NPRS) ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain.
Higher scores indicate worse pain intensity.
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Baseline
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Psychosocial risk - STarT Back Screening Tool (SBST)
Time Frame: Baseline
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Psychosocial risk assessed with the STarT Back Screening Tool (SBST).
The total score ranges from 0 to 9 and participants are classified using the standard algorithm: Low risk: total score 0-3; Medium risk: total score ≥4, with psychosocial subscale <4; High risk: psychosocial subscale score ≥4.
Higher categories indicate worse prognosis and greater risk of persistent disability.
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Baseline
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Physical activity level - International Physical Activity Questionnaire (IPAQ-SF)
Time Frame: Baseline
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Physical activity assessed with the International Physical Activity Questionnaire - Short Form (IPAQ-SF).
Participants are classified into three categories according to standard scoring criteria: Low physical activity: not meeting criteria for moderate or high levels, Moderate physical activity: at least 600 MET-minutes/week through moderate activity or walking; High physical activity: at least 1500 MET-minutes/week of vigorous activity on ≥3 days, or ≥3000 MET-minutes/week of any combination of activities.
Higher categories indicate greater levels of physical activity.
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Baseline
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Hip flexor (iliopsoas) shortening - Modified Thomas Test
Time Frame: Baseline
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Iliopsoas muscle shortening assessed using the Modified Thomas Test.
The result is classified as positive when the thigh remains elevated above the table, and negative when the thigh rests on the table surface.
Positive result indicates presence of iliopsoas shortening.
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Baseline
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Rectus femoris shortening - Modified Thomas Test
Time Frame: Baseline
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Rectus femoris muscle shortening assessed using the Modified Thomas Test.
The result is classified as positive when knee flexion is less than 80°, and negative when knee flexion is 80° or greater.
Positive result indicates presence of rectus femoris shortening.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULE-069-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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