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.
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
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 group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
Mean walking speed during gait measured in meters per second (m/s) using 3D motion analysis.
Measured: At baseline assessment
Step and stride length
Step length and stride length measured in meters (m) during gait analysis
Measured: Baseline
Cadence
Number of steps per minute during walking recorded with motion capture system (steps/min)
Measured: Baseline
Temporal gait parameters
Stance time and gait cycle time measured in seconds during gait
Measured: Baseline
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
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
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
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)
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
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
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
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
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.
- First posted18 Feb 2026
- Study start1 Oct 2025
- Primary completion26 Mar 2026
- Study completion26 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Arrate Pinto Carral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arrate Pinto Carral, Universidad de León
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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Analysis of Gait in Individuals With Low Back Pain
- ClinicalTrials.gov ID
- NCT07417345
- Acronym / sponsor ID
- LBP / ULE-069-2024
- Conditions
- Low Back Pain
- Keywords
- Gait, Chronic pain, Low Back Pain, Kinematics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Arrate Pinto CarralUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- 26 Mar 2026 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gait speed
Time frame: At baseline assessment
Mean walking speed during gait measured in meters per second (m/s) using 3D motion analysis.
Step and stride length
Time frame: Baseline
Step length and stride length measured in meters (m) during gait analysis
Cadence
Time frame: Baseline
Number of steps per minute during walking recorded with motion capture system (steps/min)
Temporal gait parameters
Time frame: Baseline
Stance time and gait cycle time measured in seconds during gait
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.
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.
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.
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.
5 secondary outcomes
Pain intensity - Numeric Pain Rating Scale (NPRS)
Time frame: Baseline
Psychosocial risk - STarT Back Screening Tool (SBST)
Time frame: Baseline
Physical activity level - International Physical Activity Questionnaire (IPAQ-SF)
Time frame: Baseline
Hip flexor (iliopsoas) shortening - Modified Thomas Test
Time frame: Baseline
Rectus femoris shortening - Modified Thomas Test
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.