Accurate Diagnosis System for Postoperative Chronic Pain Based on fMRI

Sponsor
RenJi Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03022864
Collaborator
(none)
100
16

Study Details

Study Description

Brief Summary

Postoperative pain is an ideal model for study on acute pain changing into chronic pain. The functional imaging of magnetic resonance can reflect the extent and character of pain exactly and the structural imaging of it can be a sign of the change. By analyzing fMRI results of participants with acute pain and following them up for three months, the investigators expect to find objective indicators for acute pain changing into chronic pain and give preventive analgesia for people with high risk of chronic pain.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The day before surgery, evaluate and choose patients according to inclusion and exclusion criteria. Use the same anaesthesia and management and record information needed by the case report format. Patients are examined by fMRI on their brains during the first week after surgery. Follow up the patients after surgery for three months to find out whether they have chronic pain. The NRS, DN4, ID pain and QLQ-C30 are used for each patient.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Establishment of Accurate Diagnosis and Treatment System for Postoperative Chronic Pain Based on Functional Magnetic Resonance Imaging
    Study Start Date :
    Oct 1, 2016
    Anticipated Primary Completion Date :
    Nov 1, 2017
    Anticipated Study Completion Date :
    Feb 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Chronic pain

    Follow up the patients for three months after surgery using the designed table. If the patient evaluate the pain more than 3 points according the Numerical Rating Scale, then it can be considered that the patient has chronic pain.

    No chronic pain

    Follow up the patients for three months after surgery using the designed table. If the patient evaluate the pain no more than 3 points according the Numerical Rating Scale, then it can be considered that the patient doesn't have chronic pain.

    Outcome Measures

    Primary Outcome Measures

    1. different fMRI results of specific brain regions between people with and without chronic pain [in the first week after surgery]

      amplitude of low frequency fluctuation(ALFF) and regional homogeneity(ReHo) of related brain regions

    Secondary Outcome Measures

    1. the incidence of chronic pain after mastectomy [six months after surgery]

      calculate the percentage of participants who rate pain more than three points on numerical rating scale

    2. the quality of life in patients after mastectomy [six months after surgery]

      the results of brief pain inventory in the first week after surgery and the EORTC QLQ-C30 results in the first, second and third month after surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • junior high school degree or above

    • can be communicated in mandarin normally

    • selective operation of mastectomy with or without axillary lymph node dissection

    • similar operation method and incision size

    • BMI between 18 and 30

    • ASA grade I-IIļ¼›informed consent

    Exclusion Criteria:
    • with brain disease or with brain disease history

    • Opioid allergy

    • with claustrophobia

    • with history of chronic pain

    • with psychological or emotional problems

    • Serious hearing or visual impairment

    • those who refuse to participant in this study

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

    • Study Chair: Weifeng Yu, Doctor, RenJi Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT03022864
    Other Study ID Numbers:
    • MRI20161121
    First Posted:
    Jan 18, 2017
    Last Update Posted:
    Jan 18, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 18, 2017