Back PainNCT07489638

Physiotherapist-Led School-Based Back-Health Education Program

A study testing Postural Education Workshop in people with Back Pain and Spinal Pain, run by University of Vigo at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 9 to 11 yearsHealthy volunteers can take part
Conditions the study is for: Back Pain, Spinal Pain
What is being tested?: Postural Education Workshop
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 317 participants
Where: 1 siteSpain
Study dates: 1 Mar 2019to 27 Mar 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 11 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Faculty of Physiotherapy
Pontevedra, Galicia, 36001

Other trials in Spain

About this study

Official 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

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.

Read the 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.

Conditions: Back Pain, Spinal Pain
Being tested: Postural Education Workshop
Keywords: prevention, schoolchildren, spinal pain, Back School, health education program, sedentary behavior prevention, healthy physical activity, Screen use regulation
Medical subject headings: Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Postural Education WorkshopBehavioural
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.

Study groups in NCT07489638
Study group	Role	What they receive
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. Receives: Behavioral: Postural Education Workshop

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months

Secondary outcomes (7)

Change in Postural Habits
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).
Measured: Baseline, 3 months
Change in Daily Duration of Habitual Physical Activity
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.
Measured: Baseline, 3 months
Change in Weekly Frequency of Electronic Device Use
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.
Measured: Baseline, 3 months
Satisfaction with the Educational Intervention
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.
Measured: immediately after the final workshop
Change in Backpack-Related Behaviors
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.
Measured: Baseline, 3 months
Change in Daily Duration of Electronic Device Use
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.
Measured: Baseline, 3 months
Change in Weekly Frequency of Habitual Physical Activity
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.
Measured: Baseline, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201927 Mar 2025

First posted24 Mar 2026
Study start1 Mar 2019
Primary completion31 Jul 2023
Study completion27 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 317 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07489638
Sponsor's protocol ID: 2019/094
Status last verified: Mar 2026
First submitted: 7 Mar 2026
Last updated: 24 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

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.
PubMed 16670549
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.
PubMed 17430435
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.
PubMed 14734974
Balague F, Dutoit G, Waldburger M. Low back pain in schoolchildren. An epidemiological study. Scand J Rehabil Med. 1988;20(4):175-9.
PubMed 2976526
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.
PubMed 15940479
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.
PubMed 15144357
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.
PubMed 8915066
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.
PubMed 12031782
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.
PubMed 23351394
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.
PubMed 16539729
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.
PubMed 11427402

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT07489638
Acronym / sponsor ID: 2019/094
Conditions: Back Pain, Spinal Pain
Keywords: prevention, schoolchildren, spinal pain, Back School, health education program, sedentary behavior prevention, healthy physical activity, Screen use regulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 317 participants (actual)
Lead sponsor: University of VigoUniversity, hospital or other
Collaborators: Servicio Gallego de Salud
Study start: 1 Mar 2019 (actual)
Primary completion: 31 Jul 2023 (actual)
Study completion: 27 Mar 2025 (actual)
First posted: 24 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Postural Education Workshop	Experimental	Behavioral: Postural Education WorkshopParticipants 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.

Who may qualify

Ages: 9 to 11 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Postural Education WorkshopParticipants 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.	Behavioural	Postural Education Workshop

Primary outcome

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.
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.
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.

7 secondary outcomes

Change in Postural Habits
Time frame: Baseline, 3 months
Change in Daily Duration of Habitual Physical Activity
Time frame: Baseline, 3 months
Change in Weekly Frequency of Electronic Device Use
Time frame: Baseline, 3 months
Satisfaction with the Educational Intervention
Time frame: immediately after the final workshop
Change in Backpack-Related Behaviors
Time frame: Baseline, 3 months
Change in Daily Duration of Electronic Device Use
Time frame: Baseline, 3 months
Change in Weekly Frequency of Habitual Physical Activity
Time frame: Baseline, 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
Background: PubMed 16670549Skaggs 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.
Background: PubMed 17430435Moore 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.
Background: PubMed 14734974Korovessis 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.
Background: PubMed 2976526Balague F, Dutoit G, Waldburger M. Low back pain in schoolchildren. An epidemiological study. Scand J Rehabil Med. 1988;20(4):175-9.
Background: PubMed 15940479Bejia 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.
Background: PubMed 15144357Sjolie 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.
Background: PubMed 8915066Burton 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.
Background: PubMed 12031782Watson 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.
Background: PubMed 23351394Calvo-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.
Background: PubMed 16539729Hestbaek 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.
Background: PubMed 11427402Feldman 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.
Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yoana Gonzalez Gonzalez, PhD study director

University ofVigo

Manuel Fraiz Barbeito, Graduate principal investigator

Sergas

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Postural Education Workshop in people with Back Pain and Spinal Pain, run by University of Vigo at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in spinal pain prevalence (time frame: Baseline, 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07489638, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026; AzTrials last refreshed its copy on 31 Oct 2026.