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Completed

NCT Number: NCT07417345

Biomechanical Gait Analysis in 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.

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Key information

Conditions

Low Back Pain Back Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of León - ULE MotionLab, Ponferrada Campus

Ponferrada, León, 24401, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Gait speed

    Time frame: At baseline assessment

    Mean walking speed during gait measured in meters per second (m/s) using 3D motion analysis.

  2. Step and stride length

    Time frame: Baseline

    Step length and stride length measured in meters (m) during gait analysis

  3. Cadence

    Time frame: Baseline

    Number of steps per minute during walking recorded with motion capture system (steps/min)

  4. Temporal gait parameters

    Time frame: Baseline

    Stance time and gait cycle time measured in seconds during gait

  5. Pelvis kinematics

    Time frame: Baseline

    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.

  6. Hip kinematics

    Time frame: Baseline

    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.

  7. Knee kinematics

    Time frame: Baseline

    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.

  8. Ankle kinematics

    Time frame: Baseline

    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.

Secondary outcomes

  1. Pain intensity - Numeric Pain Rating Scale (NPRS)

    Time frame: Baseline

    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.

  2. Psychosocial risk - STarT Back Screening Tool (SBST)

    Time frame: Baseline

    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.

  3. Physical activity level - International Physical Activity Questionnaire (IPAQ-SF)

    Time frame: Baseline

    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.

  4. Hip flexor (iliopsoas) shortening - Modified Thomas Test

    Time frame: Baseline

    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.

  5. Rectus femoris shortening - Modified Thomas Test

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Arrate Pinto Carral

Other

Registry information

Official study title

Biomechanical Analysis of Gait in Individuals With Low Back Pain

Acronym: LBP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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