AzTrials
AzTrials

Musculoskeletal PainLOLANCT07160478

Effectiveness of Health Education Program on Musculoskeletal Pain Management in Primary School Students

A study testing School Health Program in people with Musculoskeletal Pain and School Health, run by Universitat de Lleida 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
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Trial summary

Musculoskeletal pain during childhood can negatively affect school attendance, physical activity, and social participation. This study will evaluate the effectiveness of the school-based health education program 'SocLaLola', which uses a comic-based narrative to introduce children to pain science concepts and promote… Read more about this study

Who is it for?
Ages 8 to 11 yearsHealthy volunteers can take part
What is being tested?
School Health Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteSpain
Study dates
1 Dec 2024to 10 Aug 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 8 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Boys and girls from 8 to 11 years old.
  • Attend the 4th grade of primary education.
  • Students from selected schools participating in the CFC project.
  • Their parents or legal guardians have signed the informed consent

Who cannot join

  • Does not meet one or more inclusion criteria.
  • Does not demonstrate reading comprehension in Catalan or Spanish.
  • Does not wish to participate.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University of Lleida

    Lleida, 25001

Other trials in Spain

About this study

Official title: Effectiveness of the Soc la Lola School Health Education Program on Beliefs and Knowledge About Musculoskeletal Pain Management in 8-11-Year-Old Primary School Students: Cluster Randomized Controlled Trial

Musculoskeletal pain during childhood can negatively affect school attendance, physical activity, and social participation. This study will evaluate the effectiveness of the school-based health education program 'SocLaLola', which uses a comic-based narrative to introduce children to pain science concepts and promote healthy lifestyle habits. The intervention will be compared with a standard program focused on sedentary behavior prevention. Students aged 8 to 11 years from two primary schools will participate. The primary objective is to determine whether SocLaLola is more effective than the comparison program in improving children's knowledge about pain and in reducing fear-avoidance beliefs related to physical activity.

Read the detailed description

This randomized controlled trial will evaluate the effectiveness of the 'SocLaLola' school-based health education program compared with a sedentary lifestyle prevention program in modifying pain-related beliefs and knowledge among children aged 8 to 11 years. The primary outcomes are improvements in pain science knowledge and reductions in fear-avoidance beliefs toward physical activity.

Participants will be recruited from schools participating in the Catalan Board of Physiotherapists' School Health Program. Two primary schools will take part, each contributing two fourth-grade classes. Randomization was performed at the class level (cluster randomization), stratified by school. Within each of the two participating schools, the two fourth-grade classes were randomly allocated, one to the intervention group (SocLaLola Program) and one to the control group (Stop Sedentarism Program), using the online randomization service Sealed Envelope (Sealed Envelope Ltd, London, UK). Allocation was concealed from the outcome assessor.

Both interventions will be delivered by trained physiotherapists in a single 45-60 minute session. The SocLaLola program combines pain science education with strategies to reduce sedentary behavior, presented through a comic-based narrative. The control group will receive audiovisual materials focusing exclusively on sedentary behavior.

Assessments will be conducted at baseline, immediately after the session, and at six months. Data collection and analysis will follow a single-blind design. Ethical approval for the study was obtained from the Research Ethics Committee of the Catalan Board of Physiotherapists (CER CFC).

Being tested
School Health Program
Keywords
pain beliefs, pain education, children, muskuloskeletal pain, Fear-Avoidance, sedentary behaviors, Musculoskeletal pain prevention, primary school, School health program, pain science education
Medical subject headings
Musculoskeletal Pain, Sedentary Behavior, Health Education

What participants receive

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

  • School Health ProgramOther

    Health education interventions of approximately 60 minutes that include a conceptual presentation and a practical component.

Study groups in NCT07160478
Study groupRoleWhat they receive
SocLaLola ProgramExperimentalCombines an explanation with the comic-based story SocLaLola to teach basic concepts of pain science education and sedentary behavior prevention in an engaging and age-appropriate way.
Receives: Other: School Health Program
Stop Sedentary BehaviorActive comparatorDelivers audiovisual materials focusing exclusively on sedentary behavior prevention, without content related to pain science education.
Receives: Other: School Health Program

What is being measured

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

  1. Change in Pain Neuroscience Knowledge (COPAQ) Score

    Change in pain neuroscience knowledge will be assessed using the validated Catalan version of the Conceptualization of Pain Questionnaire (COPAQ) for children. The instrument contains 15 items with response options: true, false, or don't know. Total scores range from 0 to 15, with higher scores indicating greater knowledge of pain science.

    Measured: At baseline (before intervention), immediately after intervention (same day), and at 6 months follow-up

Secondary outcomes (3)

  1. Change in Fear-Avoidance Beliefs Regarding Physical Activity (FABQ-PA) Score

    Change in fear-avoidance beliefs will be assessed using the short Spanish version of the Fear-Avoidance Beliefs Questionnaire - Physical Activity subscale (FABQ-PA), adapted for children. The scale includes 5 items rated on a Likert scale from 0 (completely disagree) to 6 (completely agree). Total scores range from 0 to 24, with higher scores indicating greater fear-avoidance beliefs. A score above 14 is considered high fear-avoidance.

    Measured: At baseline (before intervention), immediately after intervention (same day), and at 6 months follow-up)

  2. Association Between Sociodemographic Factors and Changes in Outcome Scores

    Sociodemographic variables (age, gender, school, and reported musculoskeletal pain in household members during the past three months) will be collected and analyzed as potential modifiers of changes in FABQ-PA and COPAQ scores over time.

    Measured: At baseline (before intervention), immediately after intervention (same day), and at 6 months follow-up

  3. Children's Perceived Learning After the Educational Session

    Students will respond to the open-ended question "What do you think you learned from today's physiotherapist session?" immediately following the intervention. Qualitative responses will be analyzed thematically to explore perceived knowledge acquisition and engagement.

    Measured: Immediately after intervention (same day)

Timeline

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

  1. First posted8 Sep 2025
  2. Study start1 Dec 2024
  3. Primary completion11 Jun 2025
  4. Study completion10 Aug 2025

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized controlled trial with allocation at the class level. Following a pilot study, this trial evaluated a school-based program to prevent musculoskeletal pain in children. Four fourth-grade classes from two primary schools were randomized, stratified by school, with one class per school allocated to each arm (two clusters per arm), using Sealed Envelope (London, UK). Of the 82 students included, 42 formed the intervention group, which received the "SocLaLola" program incorporating pain science education, and 40 the control group, which received a conventional sedentary behavior prevention program. Both sessions were delivered by trained physiotherapists and lasted 45-60 minutes. Participants were assessed at baseline, immediately after the session, and at six months, on pain science knowledge (COPAQ) and fear-avoidance beliefs regarding physical activity (FABQ-PA).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07160478
Sponsor's protocol ID
SocLaLola_ULleida
Acronym
LOLA
Status last verified
Apr 2026
First submitted
17 Aug 2025
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) underlying the results reported in this trial will be shared in de-identified form. Specifically, the datasets will include socio-demographic variables (age, sex, school, cohabitant pain history), responses to the Fear-Avoidance Beliefs Questionnaire (FABQ-PA), responses to the Conceptualization of Pain Questionnaire (COPAQ), and answers to the open-ended post-intervention question. All data will be pseudonymized with unique alphanumeric codes, ensuring that no personally identifiable information will be disclosed. Study protocol, statistical analysis plan, and informed consent templates will also be made available to support secondary analyses. Access to the data will require a justified request and approval by the principal investigator, and data will be shared through secure institutional repositories in accordance with ethical guidelines and data protection regulations (GDPR).

Publications

  • Kisling S, Claus BB, Stahlschmidt L, Wager J. The efficacy of an educational movie to improve pain and dysfunctional behavior in school children: A randomized controlled trial. Eur J Pain. 2021 Aug;25(7):1612-1621. doi: 10.1002/ejp.1777. Epub 2021 May 5.

    PubMed 33949051

  • Louw A, Landrus R, Podolak J, Benz P, DeLorenzo J, Davis C, Rogers A, Cooper K, Louw C, Zimney K, Puentedura EJ, Landers MR. Behavior Change Following Pain Neuroscience Education in Middle Schools: A Public Health Trial. Int J Environ Res Public Health. 2020 Jun 23;17(12):4505. doi: 10.3390/ijerph17124505.

    PubMed 32585914

  • Kedra A, Plandowska M, Kedra P, Czaprowski D. Physical activity and low back pain in children and adolescents: a systematic review. Eur Spine J. 2021 Apr;30(4):946-956. doi: 10.1007/s00586-020-06575-5. Epub 2020 Aug 26.

    PubMed 32845380

  • Huguet A, Tougas ME, Hayden J, McGrath PJ, Stinson JN, Chambers CT. Systematic review with meta-analysis of childhood and adolescent risk and prognostic factors for musculoskeletal pain. Pain. 2016 Dec;157(12):2640-2656. doi: 10.1097/j.pain.0000000000000685.

    PubMed 27525834

Questions about this trial

What is this clinical trial studying?

A study testing School Health Program in people with Musculoskeletal Pain and School Health, run by Universitat de Lleida 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 4 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 5 Aug 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 Pain Neuroscience Knowledge (COPAQ) Score (time frame: At baseline (before intervention), immediately after intervention (same day), and at 6 months follow-up). 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 NCT07160478, which also lists 4 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 5 Aug 2026.

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