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Accurate Diagnosis System for Postoperative Chronic Pain Based on fMRI

Establishment of Accurate Diagnosis and Treatment System for Postoperative Chronic Pain Based on Functional Magnetic Resonance Imaging

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03022864
Enrollment
100
Registered
2017-01-18
Start date
2016-10-31
Completion date
2018-02-28
Last updated
2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Mammary Cancer

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.

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.

Interventions

None listed

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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-II;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

Design outcomes

Primary

MeasureTime frameDescription
different fMRI results of specific brain regions between people with and without chronic painin the first week after surgeryamplitude of low frequency fluctuation(ALFF) and regional homogeneity(ReHo) of related brain regions

Secondary

MeasureTime frameDescription
the incidence of chronic pain after mastectomysix months after surgerycalculate the percentage of participants who rate pain more than three points on numerical rating scale
the quality of life in patients after mastectomysix months after surgerythe 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026