PainNCT06290024
A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data
An observational study of Pain, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain
- What is being tested?
- A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2023to 15 Jul 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patients who are in poor condition and cannot objectively describe their symptoms or complete the questionnaire score; 2. People with severe mental system, respiratory system, cardiovascular system diseases, liver and kidney insufficiency, malignant tumors; 3. Lactation, pregnant women, or subjects with pregnancy plans within 1 month after the trial (including male subjects); 4. People with allergic diseases and allergic constitution; 5. People with infected or damaged skin at the EEG collection site; 6. Have a history of drug abuse or drug addiction;
Who may be able to join
- The subjects voluntarily participated in the study and signed an informed consent form;
- The age is between 18 years old (inclusive) and 85 years old (inclusive), regardless of gender;
- Body mass index (BMI) ≤ 45;
- Clinically clearly diagnosed neuropathological pain (pain VAS score ≥4 or above);
- Did not participate in the drug/medical device test within 3 months before the test;
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ke Ma
Shanghai, Yangpu, 200092
Ke NA Ma, PHD, 13361879260, marke72@163.com
About this study
Official title: A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data on Patients' Brain Physiology and Cognitive Function
A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function
Read the detailed description
Using the use of pain visual analog scale (VAS), digital pain grading method (NRS), neuropathic pain assessment scale (DN4), sleep quality (Pittsburgh sleep quality index, Ascens insomnia scale), social support assessment scale (SSQ), Montreal cognitive assessment scale (MoCA), Barrett impulse scale (BIS), anxiety and depression score (GAD-7, PHQ-9), emotional tasks, cognitive function (N-back, time perception, delay-discount), electroencephalogram (EEG), near-infrared brain function imaging (fNIRS) and other indicators to study the dynamic changes of various factors in the process of acute pain.
- Conditions
- Pain
- Being tested
- A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive functionDevice
Using the use of pain visual analog scale (VAS), digital pain grading method (NRS), neuropathic pain assessment scale (DN4), sleep quality (Pittsburgh sleep quality index, Ascens insomnia scale), social support assessment scale (SSQ), Montreal cognitive assessment scale (MoCA), Barrett impulse scale (BIS), anxiety and depression score (GAD-7, PHQ-9), emotional tasks, cognitive function (N-back, time perception, delay-discount), electroencephalogram (EEG), near-infrared brain function imaging (fNIRS) and other indicators to study the dynamic changes of various factors in the process of acute pain.
| Study group | Role | What they receive |
|---|---|---|
| Patients with neuropathic pain | With prospective and longitudinal research design, patients with neuropathic pain that meet the entry/displacement standards will be included in the group and receive the routine diagnosis and treatment of the pain department. At the same time, the patients admitted to the group will be clinical observation and studied. After the diagnosis and treatment, follow-up will be carried out until 3 months after joining the group. Receives: Device: A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale/Score（VAS）
VAS pain score criteria ((0-10 points) 0 Points: painless; 3 points below: have a slight pain, can tolerate; 4 points- -6 points: patients with pain and affect sleep, and can still tolerate; 7 points-10 points: the patient has gradually intense pain, the pain is unbearable, affect appetite, affect sleep.
Measured: 1 month
digital pain grading method (NRS)
Score ranged from 1 to 5, and the higher the score, the more it suggested the possibility of neuropathic pain. Clinically, when patients score ID Pain 3, neuropathic pain-related treatment options will be considered.
Measured: 1 month
neuropathic pain assessment scale (DN4)
Each assessment item was assigned 1 point for "yes" and 0 point for "no". The total score of DN4 is 0 to 10, and neuropathic pain when the total score is greater than or equal to 4.
Measured: 1 month
sleep quality (Pittsburgh sleep quality index, Ascens insomnia scale)
The PSQI was used to assess the sleep quality of the participants in the last 1 month. It consists of 19 self-assessment entries and 5 items, among which the 19th self-assessment entry and 5 items do not participate in the scoring. Only the 18 self-assessment entries participating in the scoring are introduced here (see the attached questionnaire for details). The 18 items formed 7 components, and each component was scored according to 0-3 levels. The cumulative score of PSQI total score ranged from 0 to 2 l. The higher the score, the worse the sleep quality.
Measured: 1 month
EEG
To study the dynamic change of EEG wavelength during the progression from acute pain to chronic pain，four basic waveforms, α, β, θ, δ wave, were collected。
Measured: 1 month
Barrett impulse scale (BIS)
The subject's feeling, reaction and degree of recognition are regarded as evaluation indicators, and the five-point scale classification method is adopted. Action impulse is scored positively, and unplanned impulse and cognitive impulse are scored in reverse. The standard is: "1" means never or almost never; "2" means occasional; "3" means often; "4" means always or almost always.
Measured: 1 month
(Generalized Anxiety Disorder,GAD-7)
Each entry is 0 to 3 points, the total score is the score of the 7 items, the total score ranges from 0 to 21 points A 0-4 score is found without a GAD And 5-9 points for mild GAD And 10 - 14 points for moderate GAD 15 - 21 for severe GAD
Measured: 1 month
(Patient Health Questionnaire-9
Calculate the total score 0-4 points: no depression (take care of yourself) 5-9: possible mild depression (consult a psychologist or medical worker recommended) 10-14 points: There may be moderate depression (preferably consult a psychologist or psychological medicine worker) 15-19: possible moderate to severe depression (consult a psychiatrist or psychiatrist) 20-27: possible severe depression (be sure to see a psychologist or psychiatrist) Core project points Item 1, item 4, item 9, any question score> 1 (select 2,3), need attention; item 1, item 4, representing the core symptoms of depression; Item 9 represents a self-injury mind.
Measured: 1 month
Secondary outcomes (2)
Montreal cognitive assessment scale (MoCA)
The Montreal Cognitive Assessment (Montreal Cognitive Assessment, MoCA) is a rating tool for rapid screening of cognitive abnormalities. It includes eight cognitive domains, including visual structure skills, executive function, memory, language, attention and concentration, calculation, abstract thinking and directional force. The total score of 30 and 26 were normal, with high sensitivity, covering important cognitive fields, short test time and suitable for clinical use.
Measured: 1 month
ocial support assessment scale (SSQ)
Each group of questions asked (A) how satisfied you are with the number of people who help or support you in your life, and (B) how satisfied you are with the way they / they help you.1= very dissatisfied, and 6= very satisfied.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start15 Aug 2023
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Other
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ke na ma, phd, Study chair, studay chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290024
- Sponsor's protocol ID
- XH-23-013
- Status last verified
- Nov 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data on Patients' Brain Physiology and Cognitive Function
- ClinicalTrials.gov ID
- NCT06290024
- Acronym / sponsor ID
- XH-23-013
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Jul 2025 (estimated)
- First posted
- 4 Mar 2024 (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.
A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function
Detailed description
Using the use of pain visual analog scale (VAS), digital pain grading method (NRS), neuropathic pain assessment scale (DN4), sleep quality (Pittsburgh sleep quality index, Ascens insomnia scale), social support assessment scale (SSQ), Montreal cognitive assessment scale (MoCA), Barrett impulse scale (BIS), anxiety and depression score (GAD-7, PHQ-9), emotional tasks, cognitive function (N-back, time perception, delay-discount), electroencephalogram (EEG), near-infrared brain function imaging (fNIRS) and other indicators to study the dynamic changes of various factors in the process of acute pain.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with neuropathic pain | – | Device: A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive functionWith prospective and longitudinal research design, patients with neuropathic pain that meet the entry/displacement standards will be included in the group and receive the routine diagnosis and treatment of the pain department. At the same time, the patients admitted to the group will be clinical observation and studied. After the diagnosis and treatment, follow-up will be carried out until 3 months after joining the group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients who are in poor condition and cannot objectively describe their symptoms or complete the questionnaire score; 2. People with severe mental system, respiratory system, cardiovascular system diseases, liver and kidney insufficiency, malignant tumors; 3. Lactation, pregnant women, or subjects with pregnancy plans within 1 month after the trial (including male subjects); 4. People with allergic diseases and allergic constitution; 5. People with infected or damaged skin at the EEG collection site; 6. Have a history of drug abuse or drug addiction;
Key inclusion criteria (5 listed)
- The subjects voluntarily participated in the study and signed an informed consent form;
- The age is between 18 years old (inclusive) and 85 years old (inclusive), regardless of gender;
- Body mass index (BMI) ≤ 45;
- Clinically clearly diagnosed neuropathological pain (pain VAS score ≥4 or above);
- Did not participate in the drug/medical device test within 3 months before the test;
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive functionUsing the use of pain visual analog scale (VAS), digital pain grading method (NRS), neuropathic pain assessment scale (DN4), sleep quality (Pittsburgh sleep quality index, Ascens insomnia scale), social support assessment scale (SSQ), Montreal cognitive assessment scale (MoCA), Barrett impulse scale (BIS), anxiety and depression score (GAD-7, PHQ-9), emotional tasks, cognitive function (N-back, time perception, delay-discount), electroencephalogram (EEG), near-infrared brain function imaging (fNIRS) and other indicators to study the dynamic changes of various factors in the process of acute pain. | Device | Patients with neuropathic pain |
Primary outcome
Visual Analogue Scale/Score（VAS）
Time frame: 1 month
VAS pain score criteria ((0-10 points) 0 Points: painless; 3 points below: have a slight pain, can tolerate; 4 points- -6 points: patients with pain and affect sleep, and can still tolerate; 7 points-10 points: the patient has gradually intense pain, the pain is unbearable, affect appetite, affect sleep.
digital pain grading method (NRS)
Time frame: 1 month
Score ranged from 1 to 5, and the higher the score, the more it suggested the possibility of neuropathic pain. Clinically, when patients score ID Pain 3, neuropathic pain-related treatment options will be considered.
neuropathic pain assessment scale (DN4)
Time frame: 1 month
Each assessment item was assigned 1 point for "yes" and 0 point for "no". The total score of DN4 is 0 to 10, and neuropathic pain when the total score is greater than or equal to 4.
sleep quality (Pittsburgh sleep quality index, Ascens insomnia scale)
Time frame: 1 month
The PSQI was used to assess the sleep quality of the participants in the last 1 month. It consists of 19 self-assessment entries and 5 items, among which the 19th self-assessment entry and 5 items do not participate in the scoring. Only the 18 self-assessment entries participating in the scoring are introduced here (see the attached questionnaire for details). The 18 items formed 7 components, and each component was scored according to 0-3 levels. The cumulative score of PSQI total score ranged from 0 to 2 l. The higher the score, the worse the sleep quality.
EEG
Time frame: 1 month
To study the dynamic change of EEG wavelength during the progression from acute pain to chronic pain，four basic waveforms, α, β, θ, δ wave, were collected。
Barrett impulse scale (BIS)
Time frame: 1 month
The subject's feeling, reaction and degree of recognition are regarded as evaluation indicators, and the five-point scale classification method is adopted. Action impulse is scored positively, and unplanned impulse and cognitive impulse are scored in reverse. The standard is: "1" means never or almost never; "2" means occasional; "3" means often; "4" means always or almost always.
(Generalized Anxiety Disorder,GAD-7)
Time frame: 1 month
Each entry is 0 to 3 points, the total score is the score of the 7 items, the total score ranges from 0 to 21 points A 0-4 score is found without a GAD And 5-9 points for mild GAD And 10 - 14 points for moderate GAD 15 - 21 for severe GAD
(Patient Health Questionnaire-9
Time frame: 1 month
Calculate the total score 0-4 points: no depression (take care of yourself) 5-9: possible mild depression (consult a psychologist or medical worker recommended) 10-14 points: There may be moderate depression (preferably consult a psychologist or psychological medicine worker) 15-19: possible moderate to severe depression (consult a psychiatrist or psychiatrist) 20-27: possible severe depression (be sure to see a psychologist or psychiatrist) Core project points Item 1, item 4, item 9, any question score> 1 (select 2,3), need attention; item 1, item 4, representing the core symptoms of depression; Item 9 represents a self-injury mind.
2 secondary outcomes
Montreal cognitive assessment scale (MoCA)
Time frame: 1 month
ocial support assessment scale (SSQ)
Time frame: 1 month
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 13 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
ke na ma, phd study chair
studay chair
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 Pain, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 5 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: looking for participants now, as of the sponsor's last update on 13 Nov 2024. 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?
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 jingting chen, phd (13122778387, 806041409@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale/Score（VAS） (time frame: 1 month). The study lists 8 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 13 Nov 2024.