UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030588 |
|---|---|
| Receipt number | 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 | 2023/12/05 18:04:13 |
* 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
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
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
tokiku@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical university
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
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
| 2023 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.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 |
