A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data

Pain Clinical Trial

Official title:

A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data on Patients' Brain Physiology and Cognitive Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06290024
• Other study ID #: XH-23-013
• Status: Recruiting
• Start date: August 15, 2023
• Est. completion date: August 15, 2024

Study information

• Verified date: August 2023
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: jingting chen, phd
• Phone: 13122778387
• Email: 806041409[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: August 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. The subjects voluntarily participated in the study and signed an informed consent form;

2. The age is between 18 years old (inclusive) and 85 years old (inclusive), regardless of gender;

3. Body mass index (BMI) = 45;

4. Clinically clearly diagnosed neuropathological pain (pain VAS score =4 or above);

5. Did not participate in the drug/medical device test within 3 months before the test;

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Neuralgia
• Pain

Intervention

Device:
• A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function
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.

Locations

Country	Name	City	State
China	Ke Ma	Shanghai	Yangpu

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Primary	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.	1 month
Primary	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.	1 month
Primary	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.	1 month
Primary	EEG	To study the dynamic change of EEG wavelength during the progression from acute pain to chronic pain,four basic waveforms, a, ß, ?, d wave, were collected?	1 month
Primary	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.	1 month
Primary	(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	1 month
Primary	(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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month