UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021607
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email sa57384@cd6.so-net.ne.jp

Sponsor
Institute Fukushima Medical University Department of Orthopaedic Surgery
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024921

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.