Chronic Pain Clinical Trial
Official title:
Establishment of Accurate Diagnosis and Treatment System for Postoperative Chronic Pain Based on Functional Magnetic Resonance Imaging
Verified date | January 2017 |
Source | RenJi Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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RenJi Hospital |
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
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 |
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