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

21 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

Sí

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
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.
Experimental: 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.
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.
Experimental: 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.
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.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain intensity
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sedentary behavior
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de septiembre de 2026

Finalización del estudio (Estimado)

1 de octubre de 2026

Fechas de registro del estudio

Enviado por primera vez

10 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de junio de 2026

Publicado por primera vez (Actual)

22 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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