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

NCT07160478 | Completed

• 1 other identifier: SocLaLola_ULleida
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Child, Only; Musculoskeletal Pain; Chronic Pain; School Health; Sedentary Behaviors; Health Education

Keywords

pain beliefs; pain education; children; muskuloskeletal pain; Fear-Avoidance; sedentary behaviors; Musculoskeletal pain prevention; primary school; School health program; pain science education

Outcome Measures

Primary Outcomes (1)

• Change in Pain Neuroscience Knowledge (COPAQ) Score

  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.

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

Secondary Outcomes (3)

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

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

• Association Between Sociodemographic Factors and Changes in Outcome Scores

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

• Children's Perceived Learning After the Educational Session

  Immediately after intervention (same day)

Study Arms (2)

SocLaLola Program

EXPERIMENTAL

Combines 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.

Other: School Health Program

Stop Sedentary Behavior

ACTIVE COMPARATOR

Delivers audiovisual materials focusing exclusively on sedentary behavior prevention, without content related to pain science education.

Other: School Health Program

Interventions

School Health Program OTHER

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

SocLaLola Program; Stop Sedentary Behavior

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Does not demonstrate reading comprehension in Catalan or Spanish.
• Does not wish to participate.

Sponsors & Collaborators

• Universitat de Lleida: lead

Study Sites (1)

University of Lleida

Lleida, 25001, Spain

Location

Related Publications (4)

• 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.

  PMID: 33949051 BACKGROUND

• 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.

  PMID: 32585914 BACKGROUND

• 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.

  PMID: 32845380 BACKGROUND

• 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.

  PMID: 27525834 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Pain; Chronic Pain; Sedentary Behavior; Health Education

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Clara Bergé, MSc, PT

  Universitat de Lleida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the educational nature of the intervention, it was not possible to blind participants or the physiotherapists delivering the sessions, as they were aware of the content assigned to their group. However, several procedures were implemented to ensure single-blind conditions and minimize potential bias: * The same physiotherapist delivered the educational sessions for both the intervention and control groups, ensuring consistency in delivery style. * A different member of the research team was responsible for distributing and collecting the evaluation questionnaires, reducing direct interaction between the educator and the assessment process. * Data analysis was conducted by an evaluator blinded to group allocation. * Only the principal investigator had access to the encrypted list linking participant codes to personal identifiers. * All questionnaires and records were pseudonymized using unique alphanumeric codes to preserve confidentiality and ensure data protection.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor at the University of Lleida

Model Details: After completing a pilot study, a clinical trial has been designed to evaluate an educational program aimed at preventing musculoskeletal pain in school-aged children. A total of 82 students will be divided into two groups: an intervention group (n = 42), which will participate in the new program 'SocLaLola' incorporating pain science education, and a control group (n = 40), which will follow a conventional sedentary lifestyle prevention program. Both sessions will be delivered by physiotherapists and will last between 45 and 60 minutes. Evaluations will be conducted immediately after the sessions and again six months later to assess the impact of the program on fear-avoidance beliefs regarding physical activity and on pain science knowledge.

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: September 8, 2025
• Study Start: February 10, 2022
• Primary Completion: August 10, 2025
• Study Completion: August 10, 2025
• Last Updated: January 29, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified IPD and supporting documents (Study Protocol, SAP, ICF) will be available beginning 12 months after publication of the primary results and will remain accessible for a period of 5 years through secure institutional repositories, upon reasonable request and approval by the principal investigator.
• Access Criteria: De-identified individual participant data (IPD) and supporting documents (Study Protocol, Statistical Analysis Plan, and Informed Consent Form) will be accessible to qualified researchers affiliated with academic institutions or health research organizations, for the purpose of scientific research related to pain science education, musculoskeletal health, or school-based interventions. Access will be granted upon submission of a justified research proposal, review and approval by the principal investigator, and signature of a data access agreement. Data will be shared through secure institutional repositories in accordance with ethical standards and data protection regulations (GDPR).

Locations

ES (1)