Chronic PainNCT03022864
Accurate Diagnosis System for Postoperative Chronic Pain Based on fMRI
An observational study of Chronic Pain and Mammary Cancer, run by RenJi Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Mammary Cancer
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Feb 2018
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people who undergo selective operation of mastectomy with or without axillary lymph node dissection in ambulatory operation room of Shanghai RenJi Hospital （East part ) during year 2016 to 2018
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Establishment of Accurate Diagnosis and Treatment System for Postoperative Chronic Pain Based on Functional Magnetic Resonance Imaging
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.
Read the 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.
- Conditions
- Chronic Pain, Mammary Cancer
- Medical subject headings
- Chronic Pain, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: in the first week after surgery
Secondary outcomes (2)
the incidence of chronic pain after mastectomy
calculate the percentage of participants who rate pain more than three points on numerical rating scale
Measured: six months after surgery
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
Measured: six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionNov 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weifeng Yu, Doctor, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022864
- Sponsor's protocol ID
- MRI20161121
- Status last verified
- Jan 2017
- First submitted
- 8 Jan 2017
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 15979027Bailly 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.
PubMed 24221918Baliki 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.
PubMed 20399736
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Accurate Diagnosis and Treatment System for Postoperative Chronic Pain Based on Functional Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03022864
- Acronym / sponsor ID
- MRI20161121
- Conditions
- Chronic Pain, Mammary Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people who undergo selective operation of mastectomy with or without axillary lymph node dissection in ambulatory operation room of Shanghai RenJi Hospital （East part ) during year 2016 to 2018
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- with brain disease or with brain disease history
- Opioid allergy
- with claustrophobia
- with history of chronic pain
- with psychological or emotional problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
the incidence of chronic pain after mastectomy
Time frame: six months after surgery
the quality of life in patients after mastectomy
Time frame: six months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Background: PubMed 15979027Apkarian 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.
- Background: PubMed 24221918Bailly 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.
- Background: PubMed 20399736Baliki 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weifeng Yu, Doctor study chair
RenJi Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Mammary Cancer, run by RenJi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
different fMRI results of specific brain regions between people with and without chronic pain (time frame: in the first week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03022864, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.