Pain, ChronicPreMaSyNCT05761392
APP-based Precise Management System of Chronic Intractable Pain
A study testing Precise management in people with Pain, Chronic and Pain, Intractable, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about a new management system in chronic and stubborn pain patients who accept therapy of spinal cord stimulation (SCS). Usually, these patients are required to take long-term follow-ups to ensure that the stimulator works well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic, Pain, Intractable
- What is being tested?
- Precise management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2022to 25 Sep 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been clinically diagnosed with chronic, intractable pain for more than three months.
- At enrollment, the average pain intensity is no least than 5 out of 10 cm on visual analogue scale.
- At enrollment, the age is no younger than 18-year-old.
- Ineffective or unsatisfactory conservative treatments, including but limited to: oral medication, nerve block, epidural corticosteroids, physical and psychological rehabilitation therapy, and chiropractic care.
- Voluntary to take the trial and sign the informed consent.
- Good compliance and ability to complete post-operative follow-ups.
- Basic ability to read and use a mobile phone or having a caregiver who can.
Who cannot join
- Bleeding complications or coagulation disorders.
- Mental or cognitive disorders leading to inability to complete implantation surgery or post-operative follow-up.
- Issues with spinal cord or vertebrates that are not suitable for implantation surgery.
- Systemic active infections or local infections around the surgery area.
- Pregnancy, breast-feeding, plan to be pregnant or unwilling to use contraceptive methods.
- Metastatic malignant tumors or untreated malignant tumors.
Show all 14Show fewer
- Life expectancy of less than one year.
- Already provided with a medication pump and/or other implanted devices.
- Need for therapy or examination that must not have an implanted pulse generator (IPG), such as magnetic resonance imaging (MRI) and thermo-therapy.
- Heavily addicted to alcohol or drugs.
- VAS improvement less than 50% or stimulation intolerance during the test period.
- Unable to complete long-term online follow-ups because of hardware issues such as internet, mobile phones, and so on.
- Unwilling to participate.
- Other inappropriate situations determined by the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tsinghua Chang Gung Hospital
Beijing
010-56112345 ext. +86, office@btch.edu.cn
About this study
Official title: Precise Management System (PreMaSy) of Chronic Intractable Pain Based on a Remote and Wireless Spinal Cord Stimulation System
The goal of this clinical trial is to learn about a new management system in chronic and stubborn pain patients who accept therapy of spinal cord stimulation (SCS). Usually, these patients are required to take long-term follow-ups to ensure that the stimulator works well. The main questions it aims to answer are:
- Is it better to improve the patient's quality of life than the current conventional follow-up?
- Is it better to relieve pain in the long term than the current conventional follow-up?
- Is it possible to be applied to a large population of chronic pain patients? Participants will be randomly assigned to either a control group or an interventional group.
Read more
Participants in the control group will be given the standard SCS implantation surgery and asked to complete the conventional follow-up (at least 1-, 3-, and 6-month post-operative).
Participants in the interventional group will be given the standard SCS implantation surgery and asked to do the following things:
- Take the daily pain self-assessment questions on a mobile phone APP.
- Take the monthly healthy status self-assessment questionnaires on a mobile phone APP.
- Take the conventional follow-up (at least 1-, 3-, and 6-month post-operative). Researchers will compare the two groups to see if the life quality of the interventional group is improved.
Read the detailed description
Chronic intractable pain is a disorder with complicated causes. The patient's quality of life is significantly reduced as a result of the patient's ongoing discomfort and the necessity for lengthy therapies. When patients don't respond well to medicine or other non-surgical treatments, spinal cord stimulation (SCS) is one of the surgical methods employed. The safety and effectiveness of SCS have previously been confirmed in numerous trials as a well-researched and clinically used therapy. However, the adjustment of SCS is complicated and its optimal effect relies on long-term regular follow-up. With the development of the internet, the investigators put forward a new system with remote and wireless SCS devices. Together with an exclusively developed mobile phone application, patients will be able to record their daily pain state and monthly health condition and make customized stimulation settings accordingly. This study is aimed to test the feasibility of this new precise management system. All participants will be randomly assigned to either interventional or control group. Participants in control group will be asked to take the conventional follow-up. Participants in interventional group will be additionally asked to take self-assessment on daily pain state and monthly health condition. The investigators hypothesized that this self-involved, closely monitored, and precisely adjusted system can significantly improve patients' quality of life in the long term and cut down both the financial expenses and time cost.
- Conditions
- Pain, Chronic, Pain, Intractable
- Being tested
- Precise management
- Keywords
- Pain management, Spinal cord stimulation, Remote programming, Mobile health
- Medical subject headings
- Chronic Pain, Pain, Intractable, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precise managementOther
The daily pain state assessments contain three components, the visual analogue scale (VAS) based on pain intensity, time-intensity curve throughout the day, and pain locations. The VAS scores from the first seven post-operative days will be collected as the baseline data. The interventional threshold will be determined by adding 30 mm (if the scale length were 100 mm) to the baseline mean. If participants score above the threshold three times in a row, a warning will be sent to their physicians. A remote meeting will be scheduled and stimulation settings will be adjusted accordingly.
| Study group | Role | What they receive |
|---|---|---|
| Precise management | Experimental | Participants will be asked to take daily pain state and monthly health condition assessments.
A warning for the physicians will be given when participants reach daily assessment threshold. Remote interventional meeting will be scheduled and stimulation parameters will be adjusted accordingly.
Participants will also be asked to take conventional follow-up at 1-, 3-, and 6-month post-operative. Receives: Other: Precise management |
| Conventional management | No intervention | Participants will be only asked to take conventional follow-ups at 1-, 3-, and 6-month post-operative. During these follow-ups, they will be asked to score VAS based on general pain state, and take questionnaires including EQ-5D-5L, PSQI, PGIC, CGI-I. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 1
Participants' health condition and life quality are measured by EQ-5D-5L utility values. EQ-5D-5L utility value has a minimum of 0 and a maximum of 1. Higher values mean a better health condition.
Measured: Baseline and Month 1
Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 3
Participants' health condition and life quality are measured by EQ-5D-5L utility values. EQ-5D-5L utility value has a minimum of 0 and a maximum of 1. Higher values mean a better health condition.
Measured: Baseline and Month 3
Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 6
Participants' health condition and life quality are measured by EQ-5D-5L utility values. EQ-5D-5L utility value has a minimum of 0 and a maximum of 1. Higher values mean a better health condition.
Measured: Baseline and Month 6
Secondary outcomes (21)
Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 1
Pain intensity is assessed by VAS and compared with baseline VAS score. VAS has a minimum of 0 and a maximum of 10. Higher values mean a stronger pain.
Measured: Baseline and Month 1
Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 3
Pain intensity is assessed by VAS and compared with baseline VAS score. VAS has a minimum of 0 and a maximum of 10. Higher values mean a stronger pain.
Measured: Baseline and Month 3
Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 6
Pain intensity is assessed by VAS and compared with baseline VAS score. VAS has a minimum of 0 and a maximum of 10. Higher values mean a stronger pain.
Measured: Baseline and Month 6
Pain Time: Change From Baseline in Time-Intensity Curve at Month 1
Temporal characteristics of pain is assessed by a time-intensity curve and compared with baseline curve.
Measured: Baseline and Month 1
Pain Time: Change From Baseline in Time-Intensity Curve at Month 3
Temporal characteristics of pain is assessed by a time-intensity curve and compared with baseline curve.
Measured: Baseline and Month 3
Pain Time: Change From Baseline in Time-Intensity Curve at Month 6
Temporal characteristics of pain is assessed by a time-intensity curve and compared with baseline curve.
Measured: Baseline and Month 6
Pain Location: Change From Baseline in Pain Map at Month 1
Spatial characteristics of pain is assessed by a pain map and compared with baseline pain map.
Measured: Baseline and Month 1
Pain Location: Change From Baseline in Pain Map at Month 3
Spatial characteristics of pain is assessed by a pain map and compared with baseline pain map.
Measured: Baseline and Month 3
Pain Location: Change From Baseline in Pain Map at Month 6
Spatial characteristics of pain is assessed by a pain map and compared with baseline pain map.
Measured: Baseline and Month 6
Health condition: Change From Baseline in EuroQol Visual Analogue Scale (EQ VAS) at Month 1
Overall health condition is assessed by EQ VAS and compared with baseline EQ VAS. EQ VAS has a minimum of 0 and a maximum of 100. Higher scores mean a better health condition.
Measured: Baseline and Month 1
Health condition: Change From Baseline in EuroQol Visual Analogue Scale (EQ VAS) at Month 3
Overall health condition is assessed by EQ VAS and compared with baseline EQ VAS. EQ VAS has a minimum of 0 and a maximum of 100. Higher scores mean a better health condition.
Measured: Baseline and Month 3
Health condition: Change From Baseline in EuroQol Visual Analogue Scale (EQ VAS) at Month 6
Overall health condition is assessed by EQ VAS and compared with baseline EQ VAS. EQ VAS has a minimum of 0 and a maximum of 100. Higher scores mean a better health condition.
Measured: Baseline and Month 6
Sleep Quality: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Month 1
Sleep quality is assessed by PSQI and compared with baseline PSQI score. PSQI score has a minimum of 0 and maximum of 21. Higher scores mean a worse sleep quality.
Measured: Baseline and Month 1
Sleep Quality: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Month 3
Sleep quality is assessed by PSQI and compared with baseline PSQI score. PSQI score has a minimum of 0 and maximum of 21. Higher scores mean a worse sleep quality.
Measured: Baseline and Month 3
Sleep Quality: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Month 6
Sleep quality is assessed by PSQI and compared with baseline PSQI score. PSQI score has a minimum of 0 and maximum of 21. Higher scores mean a worse sleep quality.
Measured: Baseline and Month 6
Global impression: Change From Baseline in Patient's Global Impression of Change (PGIC) at Month 1
The change of overall health condition is assessed by PGIC and compared with baseline PGIC score. PGIC score has a minimum of 1 and a maximum of 7. Higher scores mean a greater improvement in health condition.
Measured: Baseline and Month 1
Global impression: Change From Baseline in Patient's Global Impression of Change (PGIC) at Month 3
The change of overall health condition is assessed by PGIC and compared with baseline PGIC score. PGIC score has a minimum of 1 and a maximum of 7. Higher scores mean a greater improvement in health condition.
Measured: Baseline and Month 3
Global impression: Change From Baseline in Patient's Global Impression of Change (PGIC) at Month 6
The change of overall health condition is assessed by PGIC and compared with baseline PGIC score. PGIC score has a minimum of 1 and a maximum of 7. Higher scores mean a greater improvement in health condition.
Measured: Baseline and Month 6
Global impression: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Month 1
The change of overall health condition is assessed by physicians using the CGI-I and compared with baseline CGI-I score. CGI-I score has a minimum of 1 and a maximum of 7. Higher scores mean a greater improvement in health condition.
Measured: Baseline and Month 1
Global impression: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Month 3
The change of overall health condition is assessed by physicians using the CGI-I and compared with baseline CGI-I score. CGI-I score has a minimum of 1 and a maximum of 7. Higher scores mean a greater improvement in health condition.
Measured: Baseline and Month 3
Global impression: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Month 6
The change of overall health condition is assessed by physicians using the CGI-I and compared with baseline CGI-I score. CGI-I score has a minimum of 1 and a maximum of 7. Higher scores mean a greater improvement in health condition.
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start26 Sep 2022
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies 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
- Model description
- After taking the stimulator implantation surgery, participants in the interventional group are asked to take conventional follow-up including 1-, 3-, 6-month post-operative. Other than that, participants will be asked to take additional self-assessments, including daily pain state and monthly health conditions.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guihuai Wang, Beijing Tsinghua Chang Gung Hospital
- Investigators
- Yang Lu, MD, Principal investigator, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761392
- Sponsor's protocol ID
- 20220908
- Acronym
- PreMaSy
- Status last verified
- Mar 2023
- First submitted
- 9 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Han Y, Lu Y, Wang D, Ran M, Ren Q, Xie D, Aziz TZ, Li L, Wang JJ. The Use of Remote Programming for Spinal Cord Stimulation for Patients With Chronic Pain During the COVID-19 Outbreak in China. Neuromodulation. 2021 Apr;24(3):441-447. doi: 10.1111/ner.13382. Epub 2021 Mar 22.
PubMed 33751731Lu Y, Xie D, Zhang X, Dong S, Zhang H, Yu B, Wang G, Wang JJ, Li L. Management of Intractable Pain in Patients With Implanted Spinal Cord Stimulation Devices During the COVID-19 Pandemic Using a Remote and Wireless Programming System. Front Neurosci. 2020 Dec 8;14:594696. doi: 10.3389/fnins.2020.594696. eCollection 2020.
PubMed 33363453Cheng Y, Xie D, Han Y, Guo S, Sun Z, Jing L, Man W, Liu D, Yang K, Lei D, Meng Z, Zhang H, Wang G, Wu W, Wang G, Lu Y. Precise management system for chronic intractable pain patients implanted with spinal cord stimulation based on a remote programming platform: study protocol for a randomized controlled trial (PreMaSy study). Trials. 2023 Sep 11;24(1):580. doi: 10.1186/s13063-023-07595-4.
PubMed 37691092
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precise Management System (PreMaSy) of Chronic Intractable Pain Based on a Remote and Wireless Spinal Cord Stimulation System
- ClinicalTrials.gov ID
- NCT05761392
- Acronym / sponsor ID
- PreMaSy / 20220908
- Conditions
- Pain, Chronic, Pain, Intractable
- Keywords
- Pain management, Spinal cord stimulation, Remote programming, Mobile health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 9 Mar 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.
The goal of this clinical trial is to learn about a new management system in chronic and stubborn pain patients who accept therapy of spinal cord stimulation (SCS). Usually, these patients are required to take long-term follow-ups to ensure that the stimulator works well. The main questions it aims to answer are:
- Is it better to improve the patient's quality of life than the current conventional follow-up?
- Is it better to relieve pain in the long term than the current conventional follow-up?
- Is it possible to be applied to a large population of chronic pain patients? Participants will be randomly assigned to either a control group or an interventional group.
Participants in the control group will be given the standard SCS implantation surgery and asked to complete the conventional follow-up (at least 1-, 3-, and 6-month post-operative).
Participants in the interventional group will be given the standard SCS implantation surgery and asked to do the following things:
- Take the daily pain self-assessment questions on a mobile phone APP.
- Take the monthly healthy status self-assessment questionnaires on a mobile phone APP.
- Take the conventional follow-up (at least 1-, 3-, and 6-month post-operative). Researchers will compare the two groups to see if the life quality of the interventional group is improved.
Detailed description
Chronic intractable pain is a disorder with complicated causes. The patient's quality of life is significantly reduced as a result of the patient's ongoing discomfort and the necessity for lengthy therapies. When patients don't respond well to medicine or other non-surgical treatments, spinal cord stimulation (SCS) is one of the surgical methods employed. The safety and effectiveness of SCS have previously been confirmed in numerous trials as a well-researched and clinically used therapy. However, the adjustment of SCS is complicated and its optimal effect relies on long-term regular follow-up. With the development of the internet, the investigators put forward a new system with remote and wireless SCS devices. Together with an exclusively developed mobile phone application, patients will be able to record their daily pain state and monthly health condition and make customized stimulation settings accordingly. This study is aimed to test the feasibility of this new precise management system. All participants will be randomly assigned to either interventional or control group. Participants in control group will be asked to take the conventional follow-up. Participants in interventional group will be additionally asked to take self-assessment on daily pain state and monthly health condition. The investigators hypothesized that this self-involved, closely monitored, and precisely adjusted system can significantly improve patients' quality of life in the long term and cut down both the financial expenses and time cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After taking the stimulator implantation surgery, participants in the interventional group are asked to take conventional follow-up including 1-, 3-, 6-month post-operative. Other than that, participants will be asked to take additional self-assessments, including daily pain state and monthly health conditions.
| Arm | Type | Receives |
|---|---|---|
| Precise management | Experimental | Other: Precise managementParticipants will be asked to take daily pain state and monthly health condition assessments. A warning for the physicians will be given when participants reach daily assessment threshold. Remote interventional meeting will be scheduled and stimulation parameters will be adjusted accordingly. Participants will also be asked to take conventional follow-up at 1-, 3-, and 6-month post-operative. |
| Conventional management | No intervention | –Participants will be only asked to take conventional follow-ups at 1-, 3-, and 6-month post-operative. During these follow-ups, they will be asked to score VAS based on general pain state, and take questionnaires including EQ-5D-5L, PSQI, PGIC, CGI-I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have been clinically diagnosed with chronic, intractable pain for more than three months.
- At enrollment, the average pain intensity is no least than 5 out of 10 cm on visual analogue scale.
- At enrollment, the age is no younger than 18-year-old.
- Ineffective or unsatisfactory conservative treatments, including but limited to: oral medication, nerve block, epidural corticosteroids, physical and psychological rehabilitation therapy, and chiropractic care.
- Voluntary to take the trial and sign the informed consent.
Key exclusion criteria (14 listed)
- Bleeding complications or coagulation disorders.
- Mental or cognitive disorders leading to inability to complete implantation surgery or post-operative follow-up.
- Issues with spinal cord or vertebrates that are not suitable for implantation surgery.
- Systemic active infections or local infections around the surgery area.
- Pregnancy, breast-feeding, plan to be pregnant or unwilling to use contraceptive methods.
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 |
|---|---|---|
| Precise managementThe daily pain state assessments contain three components, the visual analogue scale (VAS) based on pain intensity, time-intensity curve throughout the day, and pain locations. The VAS scores from the first seven post-operative days will be collected as the baseline data. The interventional threshold will be determined by adding 30 mm (if the scale length were 100 mm) to the baseline mean. If participants score above the threshold three times in a row, a warning will be sent to their physicians. A remote meeting will be scheduled and stimulation settings will be adjusted accordingly. | Other | Precise management |
Primary outcome
Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 1
Time frame: Baseline and Month 1
Participants' health condition and life quality are measured by EQ-5D-5L utility values. EQ-5D-5L utility value has a minimum of 0 and a maximum of 1. Higher values mean a better health condition.
Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 3
Time frame: Baseline and Month 3
Participants' health condition and life quality are measured by EQ-5D-5L utility values. EQ-5D-5L utility value has a minimum of 0 and a maximum of 1. Higher values mean a better health condition.
Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 6
Time frame: Baseline and Month 6
Participants' health condition and life quality are measured by EQ-5D-5L utility values. EQ-5D-5L utility value has a minimum of 0 and a maximum of 1. Higher values mean a better health condition.
21 secondary outcomes
Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 1
Time frame: Baseline and Month 1
Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 3
Time frame: Baseline and Month 3
Pain Intensity: Change From Baseline in Visual Analogue Scale (VAS) at Month 6
Time frame: Baseline and Month 6
Pain Time: Change From Baseline in Time-Intensity Curve at Month 1
Time frame: Baseline and Month 1
Pain Time: Change From Baseline in Time-Intensity Curve at Month 3
Time frame: Baseline and Month 3
Pain Time: Change From Baseline in Time-Intensity Curve at Month 6
Time frame: Baseline and Month 6
Pain Location: Change From Baseline in Pain Map at Month 1
Time frame: Baseline and Month 1
Pain Location: Change From Baseline in Pain Map at Month 3
Time frame: Baseline and Month 3
Pain Location: Change From Baseline in Pain Map at Month 6
Time frame: Baseline and Month 6
Health condition: Change From Baseline in EuroQol Visual Analogue Scale (EQ VAS) at Month 1
Time frame: Baseline and Month 1
Health condition: Change From Baseline in EuroQol Visual Analogue Scale (EQ VAS) at Month 3
Time frame: Baseline and Month 3
Health condition: Change From Baseline in EuroQol Visual Analogue Scale (EQ VAS) at Month 6
Time frame: Baseline and Month 6
Sleep Quality: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Month 1
Time frame: Baseline and Month 1
Sleep Quality: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Month 3
Time frame: Baseline and Month 3
Sleep Quality: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) at Month 6
Time frame: Baseline and Month 6
Global impression: Change From Baseline in Patient's Global Impression of Change (PGIC) at Month 1
Time frame: Baseline and Month 1
Global impression: Change From Baseline in Patient's Global Impression of Change (PGIC) at Month 3
Time frame: Baseline and Month 3
Global impression: Change From Baseline in Patient's Global Impression of Change (PGIC) at Month 6
Time frame: Baseline and Month 6
Global impression: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Month 1
Time frame: Baseline and Month 1
Global impression: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Month 3
Time frame: Baseline and Month 3
Global impression: Change From Baseline in Clinical Global Impressions-Improvement (CGI-I) at Month 6
Time frame: Baseline and Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Background: PubMed 33751731Han Y, Lu Y, Wang D, Ran M, Ren Q, Xie D, Aziz TZ, Li L, Wang JJ. The Use of Remote Programming for Spinal Cord Stimulation for Patients With Chronic Pain During the COVID-19 Outbreak in China. Neuromodulation. 2021 Apr;24(3):441-447. doi: 10.1111/ner.13382. Epub 2021 Mar 22.
- Background: PubMed 33363453Lu Y, Xie D, Zhang X, Dong S, Zhang H, Yu B, Wang G, Wang JJ, Li L. Management of Intractable Pain in Patients With Implanted Spinal Cord Stimulation Devices During the COVID-19 Pandemic Using a Remote and Wireless Programming System. Front Neurosci. 2020 Dec 8;14:594696. doi: 10.3389/fnins.2020.594696. eCollection 2020.
- Derived from this study: PubMed 37691092Cheng Y, Xie D, Han Y, Guo S, Sun Z, Jing L, Man W, Liu D, Yang K, Lei D, Meng Z, Zhang H, Wang G, Wu W, Wang G, Lu Y. Precise management system for chronic intractable pain patients implanted with spinal cord stimulation based on a remote programming platform: study protocol for a randomized controlled trial (PreMaSy study). Trials. 2023 Sep 11;24(1):580. doi: 10.1186/s13063-023-07595-4.
- 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.
Yang Lu, MD principal investigator
Beijing Tsinghua Chang Gung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precise management in people with Pain, Chronic and Pain, Intractable, run by Beijing Tsinghua Chang Gung 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 7 inclusion and 14 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 9 Mar 2023. 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 Yang Lu, MD (18600391166 ext. +86, lya02121@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Condition and Life Quality: Change From Baseline in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility values at Month 1 (time frame: Baseline and Month 1). 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?
On the ClinicalTrials.gov record for NCT05761392, which also lists 3 linked publications.
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 9 Mar 2023.