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Completed

NCT Number: NCT07489638

Physiotherapist-Led School-Based Back-Health Education Program

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.

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Key information

Age range

9 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physiotherapy

Pontevedra, Galicia, 36001, Spain

About this study

This study investigates the impact of a physiotherapist-led, school-based back-health education program in primary schoolchildren aged 9 to 11 years. The intervention consists of a classroom-based theoretical-practical workshop delivered by physiotherapists in two 45-minute sessions. The program covers fundamental concepts of spinal anatomy and biomechanics, correct postural habits in daily activities (sitting, standing, sleeping, and rising from bed), safe backpack handling and load distribution, regular physical activity recommendations, and ergonomically appropriate use of electronic devices.

Participants complete a 21-item self-administered questionnaire at baseline and three months after the intervention. The questionnaire includes items addressing spinal pain (cervical, thoracic, and lumbar regions), pain duration and intensity, postural habits, backpack-related behaviors, physical activity patterns, and electronic device use. The study includes both symptomatic and asymptomatic schoolchildren to evaluate preventive and therapeutic outcomes.

The primary aim is to examine changes in spinal pain prevalence and characteristics following the intervention. Secondary aims include evaluating changes in postural habits, backpack-related behaviors, physical activity frequency and duration, electronic device use, and back-health knowledge. Data analysis compares pre- and post-intervention outcomes using appropriate statistical tests for paired categorical and non-normally distributed variables. The study seeks to determine whether a physiotherapist-led educational intervention implemented within the school curriculum can effectively improve back-health behaviors and modifiable ergonomic risk factors in primary schoolchildren.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Postural Education Workshop

Behavioral

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.

Primary outcomes

  1. Change in spinal pain prevalence

    Time frame: Baseline, 3 months

    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.

  2. Change in spinal pain intensity

    Time frame: Baseline, 3 months

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

  3. Change in spinal pain duration

    Time frame: Baseline, 3 months

    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.

Secondary outcomes

  1. Change in Postural Habits

    Time frame: Baseline, 3 months

    Change in postural habits, including sitting posture, sleeping posture, and method of rising from bed, assessed through a self-administered questionnaire.

    Metric: Proportion of participants reporting correct posture in each domain (sitting, sleeping, rising from bed).

  2. Change in Daily Duration of Habitual Physical Activity

    Time frame: Baseline, 3 months

    Assesses changes in the average number of hours per day that children engage in habitual physical activity (e.g., free play, sports participation, structured or unstructured movement).

    Daily duration is self-reported through the standardized 21-item questionnaire administered at both time points.

    The available response options are: "0 hours per day," "1 hour per day," "2 hours per day," "3 hours per day," and "4 hours per day." Metric: Difference in the daily duration of physical activity (hours per day) between baseline and the three-month follow-up.

  3. Change in Weekly Frequency of Electronic Device Use

    Time frame: Baseline, 3 months

    Assesses changes in the number of days per week in which children report using electronic devices. Frequency is obtained from the same self-reported 21-item questionnaire administered at both time points.

    The available response options are: "I don't play," "1-2 times per week," "3-4 times per week," "4-6 times per week," or "every day." Metric: Difference in the weekly frequency of electronic device use (days per week) between baseline and the three-month follow-up.

  4. Satisfaction with the Educational Intervention

    Time frame: immediately after the final workshop

    Assessed with a 5-item ad hoc questionnaire administered after the final workshop.

    Item 1: Ratings of duration, printed materials, presenter, theoretical lecture, and practical demonstration using a 0-4 scale (0=very poor, 4=excellent).

    Items 2-4: Impact of the workshop rated as "nothing," "a little," or "a lot" (knowledge about spine care; knowledge about physical activity benefits and sedentary risks; opinion on implementing workshops for all students).

    Item 5: Open-ended suggestion for improvement.

  5. Change in Backpack-Related Behaviors

    Time frame: Baseline, 3 months

    Change in multiple backpack-related behaviors, including backpack type, weight distribution, organization/inspection routines, and carrying method.

    Metric: Proportion of participants reporting recommended behaviors in each category.

  6. Change in Daily Duration of Electronic Device Use

    Time frame: Baseline, 3 months

    Assesses changes in the average number of hours per day that children use electronic devices (e.g., smartphone, tablet, computer, TV).

    Daily duration is self-reported through the standardized 21-item questionnaire used in the study.

    The available response options are: "0 hours per day," "1 hour per day," "2 hours per day," "3 hours per day," and "4 hours per day." Metric: Difference in the daily duration of electronic device use (hours per day) between baseline and the three-month follow-up.

  7. Change in Weekly Frequency of Habitual Physical Activity

    Time frame: Baseline, 3 months

    Assesses changes in the number of days per week in which children report engaging in physical activity. Weekly frequency is obtained from the same self-reported 21-item questionnaire used in the study.

    The available response options are: "1 day per week," "2-3 days per week," "4-6 days per week," "every day," and "never." Metric: Difference in weekly frequency of physical activity (days per week) between baseline and three-month follow-up.

Sponsors and collaborators

Lead sponsor

University of Vigo

Other

Collaborators

  • Servicio Gallego de Salud

Registry information

Official study title

Effects of a Physiotherapist-Led School-Based Back-Health Education Program on Postural Habits, Physical Activity, Electronic Device Use, and Spinal Pain in Schoolchildren With and Without Symptoms

Important dates

Study start
2019
Primary completion
2023
Study completion
2025
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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