- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07661875
Combined Physical Activity and Education Intervention for Neck and Shoulder Pain in Children
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sha Li
- Phone Number: +60147608616
- Email: lisha@student.usm.my
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 6 weeks after intervention
|
|
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.
|
Baseline and 6 weeks after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 6 weeks after intervention
|
|
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
|
Baseline and 6 weeks after intervention
|
|
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.
|
Baseline and 6 weeks after intervention
|
|
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.
|
Baseline and 6 weeks after intervention
|
|
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.
|
Baseline and 6 weeks after intervention
|
|
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.
|
Baseline and 6 weeks after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Joint Diseases
- Arthralgia
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Musculoskeletal Pain
- Shoulder Pain
- Health Services
- Health Care Facilities Workforce and Services
- Child Health Services
- Community Health Services
- Preventive Health Services
- Early Intervention, Educational
Other Study ID Numbers
- USM-NSP-PAEDU
- USM/JEPeM/PP/24060501 (Other Identifier: Ethics Approval Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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