Combined Physical Activity and Education Intervention for Neck and Shoulder Pain in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-12
SponsorLi Sha
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Physical Activity Intervention
BehavioralEach 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
BehavioralThe 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
BehavioralParticipants 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.
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: Physical Activity GroupExperimental treatment 1 intervention
Group B: Education GroupExperimental treatment 1 intervention
Group C: Combined Physical Activity and Education GroupExperimental treatment 1 intervention
Group D: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Pain intensity
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.
Time frame
Baseline and 6 weeks after intervention2
Prevalence of neck and/or shoulder pain
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.
Time frame
Baseline and 6 weeks after interventionSecondary outcomes
1
Physical activity level
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
Time frame
Baseline and 6 weeks after intervention2
Sedentary behavior
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.
Time frame
Baseline and 6 weeks after intervention3
Sleep quality
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.
Time frame
Baseline and 6 weeks after intervention4
Psychological distress
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.
Time frame
Baseline and 6 weeks after interventionLocations
Sponsors and contacts
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Li Sha
Lead sponsor
Universiti Sains Malaysia
Sponsor institution
Source ClinicalTrials.gov
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