- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07489638
Physiotherapist-Led School-Based Back-Health Education Program
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Galicia
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Pontevedra, Galicia, Spain, 36001
- Faculty of Physiotherapy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Postural Education Workshop
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline, 3 months
|
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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.
|
Baseline, 3 months
|
|
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.
|
Baseline, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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). |
Baseline, 3 months
|
|
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. |
Baseline, 3 months
|
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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. |
Baseline, 3 months
|
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Satisfaction with the Educational Intervention
Time Frame: immediately after the final workshop
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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. |
immediately after the final workshop
|
|
Change in Backpack-Related Behaviors
Time Frame: Baseline, 3 months
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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. |
Baseline, 3 months
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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. |
Baseline, 3 months
|
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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. |
Baseline, 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Yoana Gonzalez Gonzalez, PhD, University ofVigo
- Principal Investigator: Manuel Fraiz Barbeito, Graduate, Sergas
Publications and helpful links
General Publications
- 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.
- Balague F, Dutoit G, Waldburger M. Low back pain in schoolchildren. An epidemiological study. Scand J Rehabil Med. 1988;20(4):175-9.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/094
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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