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

NCT07661875 | Not Yet Recruiting

• 2 other identifiers: USM-NSP-PAEDUUSM/JEPeM/PP/24060501
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neck and Shoulder Pain; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 6 weeks after intervention

• 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.

  Baseline and 6 weeks after intervention

Secondary Outcomes (6)

• Physical activity level

  Baseline and 6 weeks after intervention

• Sedentary behavior

  Baseline and 6 weeks after intervention

• Sleep quality

  Baseline and 6 weeks after intervention

• Psychological distress

  Baseline and 6 weeks after intervention

• Physical activity enjoyment

  Baseline and 6 weeks after intervention

Study Arms (4)

Physical Activity Group

EXPERIMENTAL

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.

Behavioral: Physical Activity Intervention

Education Group

EXPERIMENTAL

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.

Behavioral: Education Intervention

Combined Physical Activity and Education Group

EXPERIMENTAL

Participants in this group will receive both the six-week physical activity intervention and the six-week health education intervention.

Behavioral: Combined Physical Activity and Education Group

Control Group

NO INTERVENTION

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.

Interventions

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.

Physical Activity Group

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.

Education Group

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.

Combined Physical Activity and Education Group

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Li Sha: lead

MeSH Terms

Conditions

Shoulder Pain; Musculoskeletal Pain

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Central Study Contacts

Sha Li

CONTACT

+60147608616; lisha@student.usm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be allocated into four parallel groups: physical activity, education, combined physical activity and education, and control groups.

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share