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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000038261
Receipt No. R000043614
Scientific Title Investigation of the frequency of acupuncture sensation on lumbar part using ultrasound-guided acupuncture
Date of disclosure of the study information 2019/10/15
Last modified on 2020/10/09

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Basic information
Public title Investigation of the frequency of acupuncture sensation on lumbar part using ultrasound-guided acupuncture
Acronym Investigation of the locomotor sensitization tissues on lumbar part using acupuncture
Scientific Title Investigation of the frequency of acupuncture sensation on lumbar part using ultrasound-guided acupuncture
Scientific Title:Acronym Investigation of the locomotor sensitization tissues on lumbar part using acupuncture
Region
Japan

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

Objectives
Narrative objectives1 Investigation of peripheral sensitization tissues in the low back pain patients.
Basic objectives2 Others
Basic objectives -Others To evaluate the frequency of acupuncture sensation
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the frequency of acupuncture sensation
Key secondary outcomes Ultrasound visibility of the lumbar part tissues and acupuncture

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
Maneuver
Interventions/Control_1 Deep acupuncture
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria low back pain group
1) chronic low back pain lasting 3 month or more
2) Patients with localized pressure pain on lumbar part
Healty control
1) Subjects do not have low back pain
Key exclusion criteria 1) Patients with lower numbness pain, numbness, weakness
2) Patients who had operation for lumbar spine in the past.
3) Patients who were determined by their doctors or head researchers to be inappropriate for research subjects for other reasons.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yoji
Middle name
Last name Kitagawa
Organization Kansai University of Health Sciences
Division name Department of Acupuncture-Moxibustion and Sports Trainer Sciences, Faculty of Health Sciences
Zip code 5900482
Address 2-11-1 Wakaba, Kumatori, Sennan, Osaka, Japan
TEL 072-453-8251
Email kitagawa@kansai.ac.jp

Public contact
Name of contact person
1st name Yoji
Middle name
Last name Kitagawa
Organization Kansai University of Health Sciences
Division name Department of Acupuncture-Moxibustion and Sports Trainer Sciences, Faculty of Health Sciences
Zip code 5900482
Address 2-11-1 Wakaba, Kumatori, Sennan, Osaka, Japan
TEL 072-453-8251
Homepage URL
Email kitagawa@kansai.ac.jp

Sponsor
Institute Kansai University of Health Sciences
Institute
Department

Funding Source
Organization Kansai University of Health Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kansai University of Health Sciences
Address 2-11-1 Wakaba, Kumatori, Sennan, Osaka, Japan
Tel 072-453-8251
Email k.kimura@kansai.ac.jp

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
2019 Year 10 Month 15 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 60
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 Main results already published
Date of protocol fixation
2019 Year 09 Month 15 Day
Date of IRB
2019 Year 10 Month 07 Day
Anticipated trial start date
2019 Year 10 Month 15 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 10 Month 10 Day
Last modified on
2020 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043614

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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