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Combined Physical Activity and Education Intervention for Neck and Shoulder Pain in Children

21 giugno 2026 aggiornato da: Li Sha

Effects of Physical Activity and Education Interventions on Neck and Shoulder Pain, Lifestyle Factors, Psychological Factors, and Quality of Life Among Primary School Children in Shijiazhuang, China

Neck and/or shoulder pain is increasingly reported among school-aged children and may affect their physical activity, daily life, psychological well-being, and quality of life. This study aims to evaluate the effects of a school-based physical activity and education intervention on neck and/or shoulder pain and related health outcomes among primary school children in Shijiazhuang, China.

Participants will be primary school children aged 10 to 12 years. They will be allocated to one of four groups: a physical activity group, an education group, a combined physical activity and education group, or a control group. The intervention will last for six weeks. The physical activity intervention will include structured game-based activities and neck-shoulder exercises, while the education intervention will include health education related to posture, screen use, physical activity, and pain prevention.

The study will assess changes in neck and/or shoulder pain, pain intensity, physical activity, sedentary behavior, sleep quality, psychological factors, quality of life, and physical activity enjoyment before and after the intervention.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • Age: 10~12 years old.
  • Clear consciousness and no language communication barriers.
  • Consent is taken from the school and from the parents and it is a voluntary participation.

Exclusion Criteria:

  • There are serious heart and respiratory diseases and other serious physical diseases.
  • People with severe cognitive dysfunction.
  • Chronic MSP caused by infectious diseases and other juvenile inflammatory conditions.
  • Have a history of congenital or acquired serious bone diseases.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Physical Activity Group
Participants in this group will receive a six-week school-based physical activity intervention. The intervention will include structured game-based physical activities and neck-shoulder exercises, delivered three times per week.
Comportamentale: Physical Activity Intervention
Each intervention session lasted for 70 minutes, conducted three times per week over a six-week period. Each session consisted of a 5-minute warm-up, 30 minutes of structured, game-based moderate-intensity PA, 30 minutes of targeted training for NSP, and a 5-minute cool-down. The intervention ensured appropriate PA volume and intensity for children. It was also designed to maintain high participation levels.
Sperimentale: Education Group
Participants in this group will receive a six-week health education intervention focusing on posture, screen use, physical activity, and prevention of neck and shoulder pain. The education sessions will be delivered twice per week.
Comportamentale: Education Intervention
The educational intervention in this study lasted for six weeks, with two sessions per week, each lasting 30 minutes, for a total of 12 instructional sessions. The content of the intervention was designed based on the principles of engagement, interactivity, and developmental appropriateness, with a central focus on enhancing primary school students' PA and promoting their physical and mental well-being. The curriculum covered topics such as PA knowledge dissemination, correct posture education, reduction of sedentary behaviour, and motivation for behavioural change.
Sperimentale: Combined Physical Activity and Education Group
Participants in this group will receive both the six-week physical activity intervention and the six-week health education intervention.
Comportamentale: Combined Physical Activity and Education Group
Participants in this group will receive a six-week combined physical activity and health education intervention. It is consistent with the intervention content of along physical activities and alone education.
Nessun intervento: Control Group
Participants in this group will continue their usual school activities and routine physical education classes without receiving the additional physical activity or health education intervention.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain intensity
Lasso di tempo: Baseline and 6 weeks after intervention
Pain intensity will be assessed using an 11-point Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Participants with neck and/or shoulder pain will report their highest pain intensity during the recall period.
Baseline and 6 weeks after intervention
Prevalence of neck and/or shoulder pain
Lasso di tempo: Baseline and 6 weeks after intervention
Neck and shoulder pain will be assessed using items adapted from the Nordic Musculoskeletal Questionnaire. Participants will report whether they have experienced neck and/or shoulder pain during the past month. The prevalence of neck and shoulder pain will be calculated as the proportion of participants reporting neck pain and/or shoulder pain.
Baseline and 6 weeks after intervention

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sedentary behavior
Lasso di tempo: Baseline and 6 weeks after intervention
Sedentary behavior will be assessed using the Adolescent Sedentary Activity Questionnaire-Chinese Version. The questionnaire records the time spent in different sedentary activities, including screen-based, educational, transport, cultural, and social sedentary activities. Total sedentary time will be calculated in minutes per week, with higher values indicating longer sedentary time.
Baseline and 6 weeks after intervention
Physical activity level
Lasso di tempo: Baseline and 6 weeks after intervention
PA was assessed using the Chinese version of the Physical Activity Questionnaire for Children (PAQ-CN), originally developed by Kowalski, Crocker, and Donen (2004) and translated and revised by Guo (2016). The PAQ-CN is a self-administered retrospective PA questionnaire designed for children and adolescents aged 7 to 18 years. It assesses general levels of PA over the previous 7 days through 10 items, each reflecting different activity dimensions during a typical week.The final PAQ-CN score ranges from 1 to 5. PA Level Classification: Based on the final PAQ-CN score, participants are classified into three PA levels:1) Low PA level: PAQ-CN ≤ 2.00 2) Middle PA level: 2.00 < PAQ-CN ≤ 3.003) High PA level: PAQ-CN > 3.00
Baseline and 6 weeks after intervention
Sleep quality
Lasso di tempo: Baseline and 6 weeks after intervention
Sleep quality will be assessed using the Mini-Sleep Questionnaire. The questionnaire includes 10 items, each scored from 1 to 7. The total score ranges from 10 to 70. The questionnaire evaluates sleep-related problems, with higher scores indicating poorer sleep quality.
Baseline and 6 weeks after intervention
Psychological distress
Lasso di tempo: Baseline and 6 weeks after intervention
Psychological distress will be assessed using the Revised Child Anxiety and Depression Scale-25. Each item is scored from 0 to 3, and the total score ranges from 0 to 75.The scale includes anxiety and depression symptoms, with higher scores indicating greater psychological distress.
Baseline and 6 weeks after intervention
Physical activity enjoyment
Lasso di tempo: Baseline and 6 weeks after intervention
Physical activity enjoyment will be assessed using the Physical Activity Enjoyment Scale. Each item is scored from 1 to 5, and the total score ranges from 16 to 80. The scale measures participants' enjoyment of physical activity, with higher scores indicating greater enjoyment.
Baseline and 6 weeks after intervention
Health-related quality of life
Lasso di tempo: Baseline and 6 weeks after intervention
Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory. The scale assesses physical, emotional, social, and school functioning. Scores are transformed to a 0 to 100 scale. The total score ranges from 0 to 100. Higher scores indicate better quality of life.
Baseline and 6 weeks after intervention

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Li Sha

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 settembre 2026

Completamento dello studio (Stimato)

1 ottobre 2026

Date di iscrizione allo studio

Primo inviato

10 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

16 giugno 2026

Primo Inserito (Effettivo)

22 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • USM-NSP-PAEDU
  • USM/JEPeM/PP/24060501 (Altro identificatore: Ethics Approval Number)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared due to participant privacy and ethical considerations, as the study involves primary school children.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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