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Not yet recruiting NCT07661875

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

No phase Interventional Neck and Shoulder Pain Musculoskeletal Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physical Activity Intervention, Education Intervention, Combined Physical Activity and Education Group.
Who it may be relevant to
Registry conditions: Neck and Shoulder Pain, Musculoskeletal Pain. Basic parameters: 10 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Interventions

  • Behavioral 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.
  • Behavioral 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,
  • Behavioral 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.

Primary outcome measures

  • Pain intensity [Time frame: Baseline and 6 weeks after intervention]
  • Prevalence of neck and/or shoulder pain [Time frame: Baseline and 6 weeks after intervention]
Secondary outcome measures (6)
  • Physical activity level [Time frame: Baseline and 6 weeks after intervention]
  • Sedentary behavior [Time frame: Baseline and 6 weeks after intervention]
  • Sleep quality [Time frame: Baseline and 6 weeks after intervention]
  • Psychological distress [Time frame: Baseline and 6 weeks after intervention]
  • Physical activity enjoyment [Time frame: Baseline and 6 weeks after intervention]
  • Health-related quality of life [Time frame: Baseline and 6 weeks after intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07661875 · USM-NSP-PAEDU · USM/JEPeM/PP/24060501

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗