Accurate Diagnosis System for Postoperative Chronic Pain Based on fMRI

Overview

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.

Full Title of Study: “Establishment of Accurate Diagnosis and Treatment System for Postoperative Chronic Pain Based on Functional Magnetic Resonance Imaging”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2017

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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • different fMRI results of specific brain regions between people with and without chronic pain
    • Time Frame: in the first week after surgery
    • amplitude of low frequency fluctuation(ALFF) and regional homogeneity(ReHo) of related brain regions

Secondary Measures

  • the incidence of chronic pain after mastectomy
    • Time Frame: six months after surgery
    • calculate the percentage of participants who rate pain more than three points on numerical rating scale
  • the quality of life in patients after mastectomy
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • RenJi Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Weifeng Yu, Doctor, Study Chair, RenJi Hospital

References

Apkarian AV, Bushnell MC, Treede RD, Zubieta JK. Human brain mechanisms of pain perception and regulation in health and disease. Eur J Pain. 2005 Aug;9(4):463-84. doi: 10.1016/j.ejpain.2004.11.001. Epub 2005 Jan 21.

Bailly F, Maigne JY, Genevay S, Marty M, Gandjbakhch F, Rozenberg S, Foltz V. Inflammatory pain pattern and pain with lumbar extension associated with Modic 1 changes on MRI: a prospective case-control study of 120 patients. Eur Spine J. 2014 Mar;23(3):493-7. doi: 10.1007/s00586-013-3036-6. Epub 2013 Sep 25.

Baliki MN, Geha PY, Fields HL, Apkarian AV. Predicting value of pain and analgesia: nucleus accumbens response to noxious stimuli changes in the presence of chronic pain. Neuron. 2010 Apr 15;66(1):149-60. doi: 10.1016/j.neuron.2010.03.002.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.