Cervical Disc HerniationNCT06092138
Edge Computing Platform for Spine Health Risk Management Based on IoT Technology
A study testing Wearable Device in people with Cervical Disc Herniation and Cervical Spinal Stenosis, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This project proposes to monitor the spinal posture of a person at rest and in motion in real time through a sensor device that contains spinal health monitoring as its core. By calibrating the five core planes on the spine and using AI algorithms to train the model, the relationship between the core plane data and… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cervical Disc Herniation, Cervical Spinal Stenosis, Ossification of Posterior Longitudinal Ligament
- What is being tested?
- Wearable Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2023to 30 Jun 2025
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 18 and 60 years.
- Degenerative diseases of the cervical spine such as cervical disc herniation, cervical stenosis, ossification of the posterior longitudinal ligament, etc., but surgery is not considered for the time being.
- Available for clinical follow-up and agree to long-term clinical follow-up and sign informed consent.
Who cannot join
- Age less than 18 years or more than 60 years.
- Life expectancy less than 1 year.
- Suffering from severe dementia (MMSE score less than 18).
- Suffering from other serious medical conditions.
- Inability to sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site
Edge Computing Platform for Spine Health Risk Management
Beijing, Beijing Municipality
About this study
This project proposes to monitor the spinal posture of a person at rest and in motion in real time through a sensor device that contains spinal health monitoring as its core. By calibrating the five core planes on the spine and using AI algorithms to train the model, the relationship between the core plane data and spine health is established.This project will output medical-grade and consumer-grade wearable spine healthcare and monitoring products, establish an interactive platform to connect the wearer, the data terminal and the professional medical team, so that patients can easily get professional health advice and reminders during home healthcare and rehabilitation; and through the collection of spine health data, establish a national spine health database.
- Conditions
- Cervical Disc Herniation, Cervical Spinal Stenosis, Ossification of Posterior Longitudinal Ligament, Neckbrace Device
- Being tested
- Wearable Device
- Keywords
- Rehabilitation, Neckbrace Device, Cervical Diesase
- Medical subject headings
- Ossification of Posterior Longitudinal Ligament
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable DeviceDevice
Whether to use wearable devices.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Device Group | Experimental | The Wearable Device Group uses wearable devices to perform rehabilitation exercises using the provided strategies. It includes the application of IoT technology to build a cloud platform combining software and hardware, using the spine sensors described in this project to collect behavioral data (it is recommended that they be worn during working hours every day for no less than 7 hours/week), and using end-to-end AI algorithms for health monitoring; the visualized data is synchronized to the spine health platform for real-time viewing and analysis by both doctors and patients. Through cell phone software and internet platform, spine health files are established to realize convenient and efficient communication between patients and professional doctors. Receives: Device: Wearable Device |
| Traditional group | No intervention | The Traditional intervention group used traditional interventions, i.e., routine patient education, guidance on rehabilitation exercises, and tips on proper lifestyle habits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
Evaluate the efficacy of the device in reducing patients' pain. A score of 0 indicates no pain and a score of 10 represents the most severe pain that is unbearable.
Measured: Enrollment baseline，the first month, the second month, the third month
neck disability index
The NDI consists of 10 items, including two parts: neck pain and related symptoms and activities of daily living. Each item has a minimum score of 0 and a maximum score of 5, with higher scores indicating more severe dysfunction.
Measured: Enrollment baseline，the first month, the second month, the third month
quality of life short form 12
Evaluate the efficacy of the device in improving patients' quality of life.The maximum value of physical score is 56.58 and the maximum value of mental score is 60.76. A higher score indicates a better quality of life.
Measured: Enrollment baseline，the first month, the second month, the third month
Secondary outcomes (2)
Change in muscle strength (grade)
Change in muscle strength (grade) = Muscle strength at the third month - Muscle strength at enrollment.
Muscle strength is graded from 0 to 5, with higher grades indicating better motor function of the extremities.
Muscle strength is evaluated by experienced physicians.
Measured: Enrollment baseline, the third month
Change in muscle tone (grade)
Change in muscle tone (grade) = Muscle tone at enrollment -Muscle tone at the third month.
Muscle tone is graded into 6 grades, with higher grades indicating worse motor function of the extremities.
Muscle tone is evaluated by experienced physicians.
Measured: Enrollment baseline, the third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start20 Oct 2023
- Primary completion31 Oct 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc HerniationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092138
- Sponsor's protocol ID
- XW-NS-NECKBRACE
- Status last verified
- Jul 2025
- First submitted
- 27 Sep 2023
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edge Computing Platform for Spine Health Risk Management Based on IoT Technology
- ClinicalTrials.gov ID
- NCT06092138
- Acronym / sponsor ID
- XW-NS-NECKBRACE
- Conditions
- Cervical Disc Herniation, Cervical Spinal Stenosis, Ossification of Posterior Longitudinal Ligament, Neckbrace Device
- Keywords
- Rehabilitation, Neckbrace Device, Cervical Diesase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 23 Oct 2023 (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.
This project proposes to monitor the spinal posture of a person at rest and in motion in real time through a sensor device that contains spinal health monitoring as its core. By calibrating the five core planes on the spine and using AI algorithms to train the model, the relationship between the core plane data and spine health is established.This project will output medical-grade and consumer-grade wearable spine healthcare and monitoring products, establish an interactive platform to connect the wearer, the data terminal and the professional medical team, so that patients can easily get professional health advice and reminders during home healthcare and rehabilitation; and through the collection of spine health data, establish a national spine health database.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wearable Device Group | Experimental | Device: Wearable DeviceThe Wearable Device Group uses wearable devices to perform rehabilitation exercises using the provided strategies. It includes the application of IoT technology to build a cloud platform combining software and hardware, using the spine sensors described in this project to collect behavioral data (it is recommended that they be worn during working hours every day for no less than 7 hours/week), and using end-to-end AI algorithms for health monitoring; the visualized data is synchronized to the spine health platform for real-time viewing and analysis by both doctors and patients. Through cell phone software and internet platform, spine health files are established to realize convenient and efficient communication between patients and professional doctors. |
| Traditional group | No intervention | –The Traditional intervention group used traditional interventions, i.e., routine patient education, guidance on rehabilitation exercises, and tips on proper lifestyle habits. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between the ages of 18 and 60 years.
- Degenerative diseases of the cervical spine such as cervical disc herniation, cervical stenosis, ossification of the posterior longitudinal ligament, etc., but surgery is not considered for the time being.
- Available for clinical follow-up and agree to long-term clinical follow-up and sign informed consent.
Key exclusion criteria (5 listed)
- Age less than 18 years or more than 60 years.
- Life expectancy less than 1 year.
- Suffering from severe dementia (MMSE score less than 18).
- Suffering from other serious medical conditions.
- Inability to sign informed consent.
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 |
|---|---|---|
| Wearable DeviceWhether to use wearable devices. | Device | Wearable Device Group |
Primary outcome
visual analogue scale
Time frame: Enrollment baseline，the first month, the second month, the third month
Evaluate the efficacy of the device in reducing patients' pain. A score of 0 indicates no pain and a score of 10 represents the most severe pain that is unbearable.
neck disability index
Time frame: Enrollment baseline，the first month, the second month, the third month
The NDI consists of 10 items, including two parts: neck pain and related symptoms and activities of daily living. Each item has a minimum score of 0 and a maximum score of 5, with higher scores indicating more severe dysfunction.
quality of life short form 12
Time frame: Enrollment baseline，the first month, the second month, the third month
Evaluate the efficacy of the device in improving patients' quality of life.The maximum value of physical score is 56.58 and the maximum value of mental score is 60.76. A higher score indicates a better quality of life.
2 secondary outcomes
Change in muscle strength (grade)
Time frame: Enrollment baseline, the third month
Change in muscle tone (grade)
Time frame: Enrollment baseline, the third month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
Related trials for Cervical Disc Herniation
Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
Active, not recruiting
Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels
Cervical Disc Herniation, Cervical Disc Degeneration
RecruitingObservational study
Gelified Radiopaque Ethanol (Absolute Gel) in Cervical Disc Herniation: an Observational Study in Routine Clinical Practice (GENESIS)
Cervical Disc Herniation, Intervertebral Disc Displacement
Active, not recruitingObservational study
Clinical Outcomes of Magnesium Sulfate in Cervical Interlaminar Epidural Steroid Injection
Cervical Radiculopathy, Cervical Disc Herniation
Not yet recruiting
Action Observation and Motor Imagery Training in Cervical Disc Herniation
Cervical Disc Herniation, Chronic Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Device in people with Cervical Disc Herniation and Cervical Spinal Stenosis, run by Xuanwu Hospital, Beijing 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 11 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (time frame: Enrollment baseline，the first month, the second month, the third month). The study lists 3 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 11 Jul 2025.