Neck and Shoulder PainNCT07661875
Combined Physical Activity and Education Intervention for Neck and Shoulder Pain in Children
A study testing Physical Activity Intervention, Education Intervention and Combined Physical Activity and Education Group in people with Neck and Shoulder Pain and Musculoskeletal Pain, run by Li Sha.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck and Shoulder Pain, Musculoskeletal Pain
- What is being tested?
- Physical Activity Intervention, Education Intervention and Combined Physical Activity and Education Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Physical Activity Intervention, Education Intervention, Combined Physical Activity and Education Group
- Medical subject headings
- Shoulder Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity InterventionBehavioural
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 InterventionBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 6 weeks after intervention
Secondary outcomes (6)
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
Measured: Baseline and 6 weeks after intervention
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.
Measured: Baseline and 6 weeks after intervention
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.
Measured: Baseline and 6 weeks after intervention
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.
Measured: Baseline and 6 weeks after intervention
Physical activity enjoyment
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.
Measured: Baseline and 6 weeks after intervention
Health-related quality of life
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.
Measured: Baseline and 6 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck and Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be allocated into four parallel groups: physical activity, education, combined physical activity and education, and control groups.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Sha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Sha, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661875
- Sponsor's protocol ID
- USM-NSP-PAEDU
- Other IDs
- USM/JEPeM/PP/24060501
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant privacy and ethical considerations, as the study involves primary school children.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07661875
- Acronym / sponsor ID
- USM-NSP-PAEDU
- Conditions
- Neck and Shoulder Pain, Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Li ShaUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be allocated into four parallel groups: physical activity, education, combined physical activity and education, and control groups.
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Group | Experimental | Behavioral: Physical Activity InterventionParticipants 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. |
| Education Group | Experimental | Behavioral: Education InterventionParticipants 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. |
| Combined Physical Activity and Education Group | Experimental | Behavioral: Combined Physical Activity and Education GroupParticipants in this group will receive both the six-week physical activity intervention and the six-week health education intervention. |
| 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. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Activity InterventionEach 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. | Behavioural | Physical Activity Group |
| Education InterventionThe 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. | Behavioural | Education Group |
| Combined Physical Activity and Education GroupParticipants 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. | Behavioural | Combined Physical Activity and Education Group |
Primary outcome
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.
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant privacy and ethical considerations, as the study involves primary school children.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Intervention, Education Intervention and Combined Physical Activity and Education Group in people with Neck and Shoulder Pain and Musculoskeletal Pain, run by Li Sha.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sha Li (+60147608616, lisha@student.usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline and 6 weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.