UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021607 |
|---|---|
| Receipt number | R000024921 |
| Scientific Title | Brain imaging trial for chronic pain |
| Date of disclosure of the study information | 2016/03/26 |
| Last modified on | 2016/03/31 13:18:35 |
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Basic information
Public title
Brain imaging trial for chronic pain
Acronym
BICP
Scientific Title
Brain imaging trial for chronic pain
Scientific Title:Acronym
BICP
Region
| Japan |
Condition
Condition
chronic pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the pathological condition by comparing the brain magnetic resonance imaging data of patients with chronic pain to that of healthy subjects.
Basic objectives2
Others
Basic objectives -Others
To reveal the changes in brain activity or construction using several magnetic resonance imaging and analytical methods.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Quantity of brain metabolite obtained by magnetic resonance spectroscopy
Key secondary outcomes
Brain volume changes obtained by voxel based morphometry, brain activity analysis using functional MRI
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Cerebral blood flow will be investigated by the resting-state fMRI, brain metabolites by MR-spectroscopy, brain gray matter volume by Voxel-based Morphometry, comparing the subjects with chronic low back pain and healthy volunteers.
Characteristics of the participants will be measured and evaluated using some questionnaires such as Pain Disability Assessment Scale (PDAS), Pain Catastrophizing Scale (PCS), Hospital Anxiety and Depression Scale (HADS), Numerical Rating Scale (NRS), and Recommended Minimum Dataset from the NIH Task Force on Research Standards for Chronic Low Back Pain.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Continuous pain of more than 3 month (12 weeks).
2. Pain with more than a 3 NRS (Numeric Rating Scale) point maximum in one day.
Key exclusion criteria
1. History of spine surgery.
2. Evidence of vertebral fracture, tumor (original or metastasizing), inflammatory disease (pyogenic spondylitis, etc.).
3. Pain caused by traffic accident or trauma.
4. With dementia.
5. Severe or unstable neuropsychiatric disease.
6. Brain disease (infarction or encephalorrhagia, etc.) or spinal cord disease.
7. Inability to keep rest position due to pain.
8. Contraindication for MRI. (that is patient with implanted cardiac pacemakers, aneurysm clip, metal implant, pregnancy or claustrophobia.)
9. No consent for present trial
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-ichi konno |
Organization
Fukushima Medical University
Division name
Orthopaedic Surgery
Zip code
Address
1, Hikarigaoka, Fukushima, Japan
TEL
024-548-2111
skonno@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuya Kameda |
Organization
Fukushima Medical University
Division name
Orthopaedic Surgery
Zip code
Address
1, Hikarigaoka, Fukushima, Japan
TEL
024-547-1276
Homepage URL
sa57384@cd6.so-net.ne.jp
Sponsor or person
Institute
Fukushima Medical University Department of Orthopaedic Surgery
Institute
Department
Personal name
Funding Source
Organization
Fukushima Prefecture Welfare Federation of Agrecultural Cooperatives,
Fukushima Medical University Department of Orthopaedic Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
福島県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The design of this study is a prospective cohort study.
Participants will be collected, according to the inclusion and exclusion criteria, from patients with chronic pain in our institution from October 2015 to September 2016. Participants will also be collected using email and bulletin boards during the same period.
Management information
Registered date
| 2016 | Year | 03 | Month | 25 | Day |
Last modified on
| 2016 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024921
