NCT06255587

Brief Summary

To examine the relationships between lumbopelvic sagittal alignment parameters (lumbar lordosis, sacral slope, pelvic tilt, and pelvic incidence) and balance control in adolescents with mechanical low back pain.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

14 days

First QC Date

February 5, 2024

Last Update Submit

February 5, 2024

Conditions

Low Back Pain, Mechanical

Outcome Measures

Primary Outcomes (3)

  • level of back pain

    Visual Analogue scale

    10 minutes

  • standardized lateral views radiographs in a neutral standing position for the lumbopelvic region

    Lumbar lordosis, sacral slope, pelvic tilt, and pelvic incidence

    15 minutes

  • Balance control

    Biodex Balance system

    20 minutes

Interventions

ScreeningOTHER

cross sectional

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Adolescents with low back pain

You may qualify if:

  • age between 15 and 18 years, either sex, and symptoms lasting longer than three months, which imply chronicity

You may not qualify if:

  • Spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for LBP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back Pain

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 13, 2024

Study Start

March 1, 2024

Primary Completion

March 15, 2024

Study Completion

April 1, 2024

Last Updated

February 13, 2024

Record last verified: 2024-02