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Completed

NCT Number: NCT07160478

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

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.

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Key information

Conditions

Child, Only Adherence Interventions Behavior Chronic Pain Health Behavior Health Education Medication Adherence Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance School Health Sedentary Behavior Sedentary Behaviors Signs and Symptoms Treatment Adherence and Compliance

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Lleida

Lleida, 25001, Spain

About this study

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 will be performed at the class level, with classes within each school allocated to either the intervention group (SocLaLola Program) or the control group (Stop Sedentarism Program) using an online random assignment tool. This procedure ensured blocked randomization by school.

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).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Boys and girls from 8 to 11 years old.
  • Attend the 3rd or 4th grade of primary education.
  • Students from selected schools participating in the CFC project.
  • Their parents or legal guardians have signed the informed consent

Exclusion criteria

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

Treatment and study plan

School Health Program

Other

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

Primary outcomes

  1. Change in Pain Neuroscience Knowledge (COPAQ) Score

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

    Change in pain neuroscience knowledge will be assessed using the validated Catalan version of the COnocimientos sobre el 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.

Secondary outcomes

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

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

    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.

  2. Association Between Sociodemographic Factors and Changes in Outcome Scores

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

    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.

  3. Children's Perceived Learning After the Educational Session

    Time frame: Immediately after intervention (same day)

    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.

Sponsors and collaborators

Lead sponsor

Universitat de Lleida

Other

Registry information

Official study 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

Acronym: LOLA

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2025
Registry last updated
May 1, 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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