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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030588
Receipt No. R000034932
Scientific Title Effect of acupuncture on cerebral blood flow in patients with Chronic low back pain - Evaluation using arterial spin-labeled magnetic resonance imaging -
Date of disclosure of the study information 2017/12/27
Last modified on 2017/12/27

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Basic information
Public title Effect of acupuncture on cerebral blood flow in patients with Chronic low back pain - Evaluation using arterial spin-labeled magnetic resonance imaging -
Acronym Effect of acupuncture on cerebral blood flow in patients with Chronic low back pain - Evaluation using arterial spin-labeled magnetic resonance imaging -
Scientific Title Effect of acupuncture on cerebral blood flow in patients with Chronic low back pain - Evaluation using arterial spin-labeled magnetic resonance imaging -
Scientific Title:Acronym Effect of acupuncture on cerebral blood flow in patients with Chronic low back pain - Evaluation using arterial spin-labeled magnetic resonance imaging -
Region
Japan

Condition
Condition Chronic low back pain
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 One of the pathologies of chronic low back pain is the reduction of cerebral blood flow centered on the prefrontal cortex. Especially, it is reported that the dorsal prefrontal cortex changes the blood flow dynamics to the mood state dependence, and the blood flow which has decreased is improved as the symptoms improve. It is suggested that the mechanism of acupuncture may influence not only the local reaction but also the high-level central nervous system. Acupuncture treatment for chronic low back pain may also influence the high-level central nervous system, possibly improving symptoms. However, there are few studies on the mechanism of acupuncture for chronic low back pain. Therefore, in this study, using the Arterial spin-labeled MRI which is noninvasive and iterative examination, it compares changes in cerebral blood flow rate before and after acupuncture stimulation and clarifies a part of the mechanism of acupuncture effect on chronic low back pain.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes cerebral blood flow
Key secondary outcomes FABQ
RDQ

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 acupuncture
Interventions/Control_2 Placebo acupuncture
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
18 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria patients diagnosed with chronic low back pain by orthopedic surgeon
Key exclusion criteria 1History of traffic accident or work injury
2 People with lower numbness pain, numbness, weakness
3 Severe disease of the liver, kidney, blood, or circulation
4 Malignant tumor or its history
5 refractory depression diagnosed by personality disorder, intellectual disability, or physician's discretionary power
6 Substance dependence or substance abuse (excluding disorders caused by nicotine)
7 experience of claustrophobic reaction
8 Persons wearing cardiac pacemakers Persons holding artificial heart valves
9 People who hold metals in the body that can not be confirmed as nonmagnetic (such as tattoo)
10 Persons with poor body temperature control
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yamaguchi Satoru
Organization Saitama Medical University
Division name oriental Medicine
Zip code
Address 38 morohongo ,MOroyamamachi , irumagun , Saromama , Japan
TEL 049-276-1193
Email tokiku@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name ikuchi Tomokazu
Organization Saitama Medical University
Division name Oriental Medicine
Zip code
Address 38 morohongo , iruma-gun , moroyamamachi, saitama , japan
TEL 049-276-1193
Homepage URL
Email tokiku@saitama-med.ac.jp

Sponsor
Institute Saitama Medical university
Institute
Department

Funding Source
Organization The Japanese society of balneology , climatology and physical Medicine
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

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 27 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 27 Day
Last modified on
2017 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034932

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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