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Low Back PainLBPNCT07417345

Biomechanical Gait Analysis in Low Back Pain

An observational study of Low Back Pain, run by Arrate Pinto Carral at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Low Back Pain
How many people
74 participants
Where
1 siteSpain
Study dates
1 Oct 2025to 26 Mar 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Participants will be adults from the community of León (Spain) and surrounding area, including university students, staff, and members of the general public. Individuals with and without low back pain will be recruited through public advertisements and local healthcare centers. The study population represents community-dwelling adults who are able to attend the gait analysis laboratory at the University of León.

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • University of León - ULE MotionLab, Ponferrada Campus

    Ponferrada, León, 24401

Other trials in Spain

About this study

Official title: 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.
Read the 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.

Conditions
Low Back Pain
Keywords
Gait, Chronic pain, Low Back Pain, Kinematics
Medical subject headings
Low Back Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07417345
Study groupRoleWhat they receive
Low Back Pain GroupAdults over 18 years with current or recent low back pain without leg pain, who undergo clinical assessment and gait analysis in a motion laboratory.
Control GroupAdults over 18 years without low back pain who undergo the same clinical assessment and gait analysis as the low back pain group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gait speed

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

    Measured: At baseline assessment

  2. Step and stride length

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

    Measured: Baseline

  3. Cadence

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

    Measured: Baseline

  4. Temporal gait parameters

    Stance time and gait cycle time measured in seconds during gait

    Measured: Baseline

  5. Pelvis kinematics

    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.

    Measured: Baseline

  6. Hip kinematics

    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.

    Measured: Baseline

  7. Knee kinematics

    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.

    Measured: Baseline

  8. Ankle kinematics

    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.

    Measured: Baseline

Secondary outcomes (5)
  1. Pain intensity - Numeric Pain Rating Scale (NPRS)

    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.

    Measured: Baseline

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

    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.

    Measured: Baseline

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

    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.

    Measured: Baseline

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

    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.

    Measured: Baseline

  5. Rectus femoris shortening - Modified Thomas Test

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2026
  2. Study start1 Oct 2025
  3. Primary completion26 Mar 2026
  4. Study completion26 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07417345
Sponsor's protocol ID
ULE-069-2024
Acronym
LBP
Status last verified
Apr 2026
First submitted
3 Feb 2026
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data will be shared in Microsoft Excel format upon reasonable request after publication. The dataset will include variables related to gait analysis and clinical measures, with all personal identifiers removed to protect confidentiality.

Questions about this trial

What is this clinical trial studying?

An observational study of Low Back Pain, run by Arrate Pinto Carral at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gait speed (time frame: At baseline assessment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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Biomechanical Gait Analysis in Low Back Pain | AzTrials