UMIN-CTR Clinical Trial

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

chronic pain

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Fukushima Medical University Department of Orthopaedic Surgery

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

福島県立医科大学附属病院

Date of disclosure of the study information

2016

Year

03

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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