Low Back PainNCT04971616
Risk Screening and Assessment of Shoulder, Neck and Lower Back Discomfort.
An observational study of Low Back Pain and Neck Pain, run by Peking University Third Hospital at 1 site in China.
Trial summary
Identifying high-risk factors that may lead to shoulder, neck and lower back discomfort and contributing to the primary prevention of disease progression. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Neck Pain, Shoulder Pain
- What is being tested?
- Demographic data and range of motion.
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 20-40 year of age with shoulder, neck and lower back discomfort
Who may be able to join
- 20-40 year of age with symptoms of shoulder
- Neck and lower back discomfort
Who cannot join
- Red flag sign of the neck
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Jian-quan Wang, M.D., 13801076267, keny1417@vip.sina.com
About this study
Identifying high-risk factors that may lead to shoulder, neck and lower back discomfort and contributing to the primary prevention of disease progression.
Read the detailed description
The purpose of this study is to design a self-assessment scheme for clinical assessment of shoulder, neck and lower back function and compare the consistency between clinical assessment and self-assessment. The body parameters (BMI, age, gender), daily activities (daily steps, sedentary), work and rest time (sleep time, quality) were collected through wearable devices, evaluating the risk factors of shoulder, neck and lower back discomfort.
- Conditions
- Low Back Pain, Neck Pain, Shoulder Pain
- Being tested
- Demographic data and range of motion.
- Medical subject headings
- Low Back Pain, Neck Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demographic data and range of motion.Other
The body parameters (BMI, age, gender), daily activities (daily steps, sedentary), work and rest time (sleep time, quality) were collected through wearable devices. The range of motion of neck and waist was collected through hand-held devices.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Patients with shoulder, neck and lower back discomfort | Patients with shoulder, neck and lower back discomfort. Receives: Other: Demographic data and range of motion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion (ROM) of the neck
Patients' range of motion of the neck in all directions are measured using hand-held devices.
Measured: at least 2-week monitoring by wearable devices
Oswestry Disability Index (ODI)
Oswestry Disability Index of the neck is collected for the evaluation of neck functions.
Measured: at least 2-week monitoring by wearable devices
Visual Analogue Scale (VAS)
Visual Analogue Scale is collected for pain assessment.
Measured: at least 2-week monitoring by wearable devices
Roland-Morris Disability Questionnaire (RDQ)
Roland-Morris Disability Questionnaire is collected for the evaluation of lower back functions.
Measured: at least 2-week monitoring by wearable devices
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Aug 2020
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian-quan Wang, M.D., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971616
- Sponsor's protocol ID
- M2020342
- Status last verified
- Jul 2021
- First submitted
- 27 Jun 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Screening and Assessment of Shoulder, Neck and Lower Back Discomfort.
- ClinicalTrials.gov ID
- NCT04971616
- Acronym / sponsor ID
- M2020342
- Conditions
- Low Back Pain, Neck Pain, Shoulder Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 21 Jul 2021 (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.
Identifying high-risk factors that may lead to shoulder, neck and lower back discomfort and contributing to the primary prevention of disease progression.
Detailed description
The purpose of this study is to design a self-assessment scheme for clinical assessment of shoulder, neck and lower back function and compare the consistency between clinical assessment and self-assessment. The body parameters (BMI, age, gender), daily activities (daily steps, sedentary), work and rest time (sleep time, quality) were collected through wearable devices, evaluating the risk factors of shoulder, neck and lower back discomfort.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1: Patients with shoulder, neck and lower back discomfort | – | Other: Demographic data and range of motion.Patients with shoulder, neck and lower back discomfort. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 20-40 year of age with shoulder, neck and lower back discomfort
Key inclusion criteria (2 listed)
- 20-40 year of age with symptoms of shoulder
- Neck and lower back discomfort
Key exclusion criteria (1 listed)
- Red flag sign of the neck
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 |
|---|---|---|
| Demographic data and range of motion.The body parameters (BMI, age, gender), daily activities (daily steps, sedentary), work and rest time (sleep time, quality) were collected through wearable devices. The range of motion of neck and waist was collected through hand-held devices. | Other | Group 1: Patients with shoulder, neck and lower back discomfort |
Primary outcome
Range of motion (ROM) of the neck
Time frame: at least 2-week monitoring by wearable devices
Patients' range of motion of the neck in all directions are measured using hand-held devices.
Oswestry Disability Index (ODI)
Time frame: at least 2-week monitoring by wearable devices
Oswestry Disability Index of the neck is collected for the evaluation of neck functions.
Visual Analogue Scale (VAS)
Time frame: at least 2-week monitoring by wearable devices
Visual Analogue Scale is collected for pain assessment.
Roland-Morris Disability Questionnaire (RDQ)
Time frame: at least 2-week monitoring by wearable devices
Roland-Morris Disability Questionnaire is collected for the evaluation of lower back functions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jian-quan Wang, M.D. study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Neck Pain, run by Peking University Third Hospital at 1 site in China.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian-quan Wang, M.D. (13801076267, keny1417@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (ROM) of the neck (time frame: at least 2-week monitoring by wearable devices). The study lists 4 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 21 Jul 2021.