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

NCT06290024 | Recruiting

• 1 other identifier: XH-23-013
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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。

  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.

  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

  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.

  1 month

Secondary Outcomes (2)

• Montreal cognitive assessment scale (MoCA)

  1 month

• ocial support assessment scale (SSQ)

  1 month

Study Arms (1)

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.

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

Interventions

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

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.

Patients with neuropathic pain

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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;

You may qualify if:

• 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;

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ke Ma

Shanghai, Yangpu, 200092, China

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ke na ma, phd

  studay chair

  STUDY CHAIR

Central Study Contacts

jingting chen, phd

CONTACT

13122778387; 806041409@qq.com

ke ma, phd

CONTACT

13361879260; marke72@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: March 4, 2024
• Study Start: August 15, 2023
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: November 13, 2024

Record last verified: 2024-11

Locations

CN (1)