Accurate Diagnosis System for Postoperative Chronic Pain Based on fMRI

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03022864
• Other study ID #: MRI20161121
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 8, 2017
• Last updated: January 17, 2017
• Start date: October 2016
• Est. completion date: February 2018

Study information

• Verified date: January 2017
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: February 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Chronic Pain
• Mammary Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	different fMRI results of specific brain regions between people with and without chronic pain	amplitude of low frequency fluctuation(ALFF) and regional homogeneity(ReHo) of related brain regions	in the first week after surgery
Secondary	the incidence of chronic pain after mastectomy	calculate the percentage of participants who rate pain more than three points on numerical rating scale	six months after surgery
Secondary	the quality of life in patients after mastectomy	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	six months after surgery