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Effects of a Postural Education Multicomponent Intervention in Primary School Children.

Effects of a Postural Education Multicomponent Intervention in Primary School Children.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06668129
Acronym
PEPE
Enrollment
849
Registered
2024-10-31
Start date
2021-02-01
Completion date
2021-06-11
Last updated
2024-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain Lower Back, Physical Activity

Brief summary

The present study, named PEPE project, aims to study the effects of a 9-month postural educational multicomponent intervention on back health in schoolchildren. As well as, this project aims to examine the effectiveness of the intervention on teachers. Total of 2000 children aged 10 to 12 and 20 schools will be randomized into an intervention group (N=1000 children, N=10 schools) and a control group (N=1000 children, N=10 schools). A 9-months intervention program will be implemented. Participants will be evaluated three times: before the intervention (baseline, Month 0), after the intervention (post-test, Month 9) and 6 months after the intervention finished (follow-up, Month 15). The intervention will consist on: (1) nine oral presentations delivered at school, (2) multisubject teaching unit, (3) information campaign widespread by the school (i.e. posters, triptychs, school website, social networks, etc.), and (4) The Back-Care Day at school. The effectiveness of the intervention will be evaluated by means of primary outcomes which include the back-care knowledge of schoolchildren. As well as, a set of secondary outcomes such as daily postural habits, use of a backpack, and LBP prevalence in schoolchildren and among teachers involved will be studied. This intervention will provide new insights into the prevention of childhood LBP which may lead to a better management of this health problem throughout an individuals lifetime.

Interventions

BEHAVIORALBack care intervention program

The back care intervention consists of: 1. Nine oral presentations. Include Programa Suma't programme developed by the Provincial Council of Majorca. 2. Multisubject Teaching Unit. 3. Information campaign widespread by the school (i.e. posters, triptychs, school website, social networks, etc.) 4. The Back Care Day at school.

Sponsors

State Research Agency, Spain
CollaboratorOTHER_GOV
European Regional Development Fund
CollaboratorOTHER
Ministry of Science and Innovation, Spain
CollaboratorOTHER_GOV
University of the Balearic Islands
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* Children aged between 10 and 12 years, who belonged to the fifth and sixth grades of primary school.

Exclusion criteria

* Children with some type of medical condition that may affect the results of the measurements or that present some limitation of their abilities that prevents the intervention program from developing normally.

Design outcomes

Primary

MeasureTime frameDescription
Knowledge of back health16 weeksValidated questionnaire with Spanish children (Cronbach's alpha = 0.82) will be used to ascertain children's' level of knowledge on back care in daily life physical activities. Specifically, this questionnaire has 24 multiple choice items associated with one of the following categories according to conceptual knowledge: topographicalanatomical knowledge (items 1, 2, 3 and 6); functional-anatomical knowledge (items 4, 5 and 7); habits in standing posture (items 8-10); or seated (items 11-13); or lying (items 23 and 24); habits in carrying heavy objects in a backpack (items 14-18); and how to move heavy loads (items 19-22). Additionally, the questionnaire validated with Spanish schoolchildren and used in Méndez et al. will be used to assess back posture knowledge related to general principles of good body mechanics and fear-avoiding beliefs.

Secondary

MeasureTime frameDescription
Daily postural habits16 weeksDaily life habits will be assessed by means of a questionnaire that will be fulfilled by the children. The questionnaire include the following items: being allowed to leave the academic material at school (yes=1/no=0), correct use of sofa (yes/no), stooping correctly (yes/no), take care to sit correctly at home (yes/no), take care to sit correctly at school (yes/no), frequent posture change on chair at home (yes/no), and frequent posture change on chair at school (yes/no).
Backpack use16 weeksCorrect use of backpack will be assessed by means of a questionnaire that will be fulfilled by the children. The questionnaire include the following items: try to load the minimum weight possible, carry a backpack on two shoulders, belief that school backpack weight does not affect the back and the use of a locker or similar at school. The weight of the children's' backpack will be also measured.
LBP prevalence16 weeksThe instrument to evaluate LBP prevalence will be based using a validated questionnaire. Data related to LBP included in the questionnaire were the following: LBP experience during the student's lifetime (never, almost never, sometimes, often, always), LBP impeding usual activities (never, only when in pain, always), treatment received for LBP (no, rehabilitation, drugs, surgery, others), LBP in bed during the night or upon waking (yes, no), LBP during the last week (yes, no), LBP during or at the end of a physical education (PE) class (never, almost never, sometimes, often, always), diagnosis of scoliosis and diagnosis of different leg length (yes, no).
Back care knowledge16 weeksLow Back Pain Knowledge Questionnaire (LKQ) will be used as an instrument to assess knowledge about back pain in teachers. This questionnaire is composed of 16 questions, divided into the following categories: general aspects, concepts, and treatment. The total maximum score is 24 and is classified into one of three levels: low (0 - 14), moderate (15 - 18), and high (19 - 24).
LBP prevalence and daily postural habits16 weeksThe Quebec Back Pain Disability Scale will be used to assess daily postural habits of teachers. The scale exists of one central question: Do you have trouble today with...? followed by 20 activities of daily life. In every activity, there are 6 answer categories, measured by using a Likert scale from 0-5 (0 = no effort, 5 = not able to). The final outcome is obtained by the sum of the scoring of the degree of difficulty in performing the 20 daily activities. These outcomes score within the range of 0 and 100, determents the level of functional disability, with higher numbers representing greater levels of disability.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026