NCT07489638

Brief Summary

This study evaluates the effects of a physiotherapist-led, school-based back-health education program delivered in primary school classrooms. The intervention consists of a theoretical-practical workshop focused on postural habits, physical activity, electronic device use, and backpack handling. The study includes schoolchildren with and without spinal pain and assesses changes in spinal pain characteristics, postural behaviors, physical activity patterns, and electronic device use over a three-month period. The main objective is to determine whether this educational program improves back-health behaviors and related outcomes in the school setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
317

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

4.4 years

First QC Date

March 7, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

preventionschoolchildrenspinal painBack Schoolhealth education programsedentary behavior preventionhealthy physical activityScreen use regulation

Outcome Measures

Primary Outcomes (3)

  • Change in spinal pain prevalence

    Change in the prevalence of spinal pain (cervical, thoracic, and lumbar), assessed using a self-administered questionnaire. Metric: Proportion of participants reporting spinal pain in each spinal region at both assessment points.

    Baseline, 3 months

  • Change in spinal pain intensity

    Change in spinal pain intensity measured using the Wong-Baker FACES Pain Scale. Metric: Difference in score (0-10) between baseline and 3 months.

    Baseline, 3 months

  • Change in spinal pain duration

    Change in spinal pain duration categories (\<12 h, 12-24 h, 1-7 days, \>1 week). Metric: Shift in categorical distribution from baseline to 3 months.

    Baseline, 3 months

Secondary Outcomes (7)

  • Change in Postural Habits

    Baseline, 3 months

  • Change in Daily Duration of Habitual Physical Activity

    Baseline, 3 months

  • Change in Weekly Frequency of Electronic Device Use

    Baseline, 3 months

  • Satisfaction with the Educational Intervention

    immediately after the final workshop

  • Change in Backpack-Related Behaviors

    Baseline, 3 months

  • +2 more secondary outcomes

Study Arms (1)

Postural Education Workshop

EXPERIMENTAL

Participants receive a two-session educational workshop delivered by physiotherapists. The workshop covers basic spinal anatomy, postural hygiene, the importance of extracurricular physical activity, and strategies to regulate screen use to reduce sedentary behavior. Each session lasts 45 minutes, held 2-3 weeks apart, and includes both theoretical and practical components such as proper sitting and standing posture, ergonomic adjustment of the school workstation, correct backpack use, load handling, and promotion of active habits.

Behavioral: Postural Education Workshop

Interventions

Participants receive a two-session educational workshop delivered by physiotherapists. The workshop covers basic spinal anatomy, postural hygiene, the importance of extracurricular physical activity, and strategies to regulate screen use to reduce sedentary behavior. Each session lasts 45 minutes, held 2-3 weeks apart, and includes both theoretical and practical components such as proper sitting and standing posture, ergonomic adjustment of the school workstation, correct backpack use, load handling, and promotion of active habits.

Postural Education Workshop

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Acceptance by the school administration and the Parents' Association (AMPA) to participate in the project.
  • Commitment from the school administration to ensure that students and teaching staff participating in the project complete the questionnaires on the dates indicated by the research team.
  • Students aged 9 to 11 years at the start of the study.

You may not qualify if:

  • Lack of acceptance from the school administration or AMPA to participate in the study.
  • Failure by the school administration to ensure completion of the questionnaires on the scheduled dates.
  • Students with cognitive impairments that prevent them from understanding or responding to the questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physiotherapy

Pontevedra, Galicia, 36001, Spain

Location

Related Publications (11)

  • Skaggs DL, Early SD, D'Ambra P, Tolo VT, Kay RM. Back pain and backpacks in school children. J Pediatr Orthop. 2006 May-Jun;26(3):358-63. doi: 10.1097/01.bpo.0000217723.14631.6e.

    PMID: 16670549BACKGROUND
  • Moore MJ, White GL, Moore DL. Association of relative backpack weight with reported pain, pain sites, medical utilization, and lost school time in children and adolescents. J Sch Health. 2007 May;77(5):232-9. doi: 10.1111/j.1746-1561.2007.00198.x.

    PMID: 17430435BACKGROUND
  • Korovessis P, Koureas G, Papazisis Z. Correlation between backpack weight and way of carrying, sagittal and frontal spinal curvatures, athletic activity, and dorsal and low back pain in schoolchildren and adolescents. J Spinal Disord Tech. 2004 Feb;17(1):33-40. doi: 10.1097/00024720-200402000-00008.

    PMID: 14734974BACKGROUND
  • Balague F, Dutoit G, Waldburger M. Low back pain in schoolchildren. An epidemiological study. Scand J Rehabil Med. 1988;20(4):175-9.

    PMID: 2976526BACKGROUND
  • Bejia I, Abid N, Ben Salem K, Letaief M, Younes M, Touzi M, Bergaoui N. Low back pain in a cohort of 622 Tunisian schoolchildren and adolescents: an epidemiological study. Eur Spine J. 2005 May;14(4):331-6. doi: 10.1007/s00586-004-0785-2. Epub 2004 Sep 30.

    PMID: 15940479BACKGROUND
  • Sjolie AN. Low-back pain in adolescents is associated with poor hip mobility and high body mass index. Scand J Med Sci Sports. 2004 Jun;14(3):168-75. doi: 10.1111/j.1600-0838.2003.00334.x.

    PMID: 15144357BACKGROUND
  • Burton AK, Clarke RD, McClune TD, Tillotson KM. The natural history of low back pain in adolescents. Spine (Phila Pa 1976). 1996 Oct 15;21(20):2323-8. doi: 10.1097/00007632-199610150-00004.

    PMID: 8915066BACKGROUND
  • Watson KD, Papageorgiou AC, Jones GT, Taylor S, Symmons DP, Silman AJ, Macfarlane GJ. Low back pain in schoolchildren: occurrence and characteristics. Pain. 2002 May;97(1-2):87-92. doi: 10.1016/s0304-3959(02)00008-8.

    PMID: 12031782BACKGROUND
  • Calvo-Munoz I, Gomez-Conesa A, Sanchez-Meca J. Prevalence of low back pain in children and adolescents: a meta-analysis. BMC Pediatr. 2013 Jan 26;13:14. doi: 10.1186/1471-2431-13-14.

    PMID: 23351394BACKGROUND
  • Hestbaek L, Leboeuf-Yde C, Kyvik KO. Are lifestyle-factors in adolescence predictors for adult low back pain? A cross-sectional and prospective study of young twins. BMC Musculoskelet Disord. 2006 Mar 15;7:27. doi: 10.1186/1471-2474-7-27.

    PMID: 16539729BACKGROUND
  • Feldman DE, Shrier I, Rossignol M, Abenhaim L. Risk factors for the development of low back pain in adolescence. Am J Epidemiol. 2001 Jul 1;154(1):30-6. doi: 10.1093/aje/154.1.30.

    PMID: 11427402BACKGROUND

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yoana Gonzalez Gonzalez, PhD

    University ofVigo

    STUDY DIRECTOR
  • Manuel Fraiz Barbeito, Graduate

    Sergas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 7, 2026

First Posted

March 24, 2026

Study Start

March 1, 2019

Primary Completion

July 31, 2023

Study Completion

March 27, 2025

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the study collected anonymous questionnaire-based information from minors within an educational setting, and the dataset does not include identifiers that allow linkage at the individual level. In addition, the ethical approval and institutional agreements specify that the data may only be used in aggregated form for research purposes. Therefore, no IPD will be made available for public sharing.

Locations