Biomechanical Gait Analysis in Low Back Pain

NCT07417345 | Completed

• 1 other identifier: ULE-069-2024
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Low Back Pain

Keywords

Gait; Chronic pain; Low Back Pain; Kinematics

Outcome Measures

Primary Outcomes (8)

• Gait speed

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

  At baseline assessment

• Step and stride length

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

  Baseline

• Cadence

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

  Baseline

• Temporal gait parameters

  Stance time and gait cycle time measured in seconds during gait

  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.

  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.

  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.

  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.

  Baseline

Secondary Outcomes (5)

• Pain intensity - Numeric Pain Rating Scale (NPRS)

  Baseline

• Psychosocial risk - STarT Back Screening Tool (SBST)

  Baseline

• Physical activity level - International Physical Activity Questionnaire (IPAQ-SF)

  Baseline

• Hip flexor (iliopsoas) shortening - Modified Thomas Test

  Baseline

• Rectus femoris shortening - Modified Thomas Test

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arrate Pinto Carral: lead

Study Sites (1)

University of León - ULE MotionLab, Ponferrada Campus

Ponferrada, León, 24401, Spain

Location

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Permanent Lecturer, Department of Nursing and Physiotherapy, University of León

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 18, 2026
• Study Start: October 1, 2025
• Primary Completion: March 26, 2026
• Study Completion: March 26, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available upon reasonable request from September 2026, and will be publicly deposited in an institutional repository after publication of the main manuscript, with no defined end date.
• Access Criteria: Access will be granted to qualified researchers upon reasonable request. De-identified data in Excel format and supporting documents will be shared after approval of a research proposal and under a data use agreement to ensure confidentiality. After publication, data may also be accessible through the institutional repository of the University of León under open access conditions.

Locations

ES (1)