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NCT Number: NCT07661875

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

physical activity intervention

Behavioral

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.

Education Intervention

Behavioral

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.

Combined Physical Activity and Education Group

Behavioral

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.

Primary outcomes

  1. Pain intensity

    Time frame: 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.

  2. Prevalence of neck and/or shoulder pain

    Time frame: 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.

Secondary outcomes

  1. Physical activity level

    Time frame: 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

  2. Sedentary behavior

    Time frame: 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.

  3. Sleep quality

    Time frame: 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.

  4. Psychological distress

    Time frame: 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.

  5. Physical activity enjoyment

    Time frame: 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.

  6. Health-related quality of life

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Li Sha

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 24, 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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