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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042574
Receipt No. R000048593
Scientific Title Immediate Effect of acupuncture on sensitized tissue in patients with chronic low back pain.
Date of disclosure of the study information 2020/12/01
Last modified on 2021/05/28

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Basic information
Public title Immediate Effect of acupuncture on sensitized tissue in patients with chronic low back pain.
Acronym Immediate Effect of acupuncture on sensitized tissue.
Scientific Title Immediate Effect of acupuncture on sensitized tissue in patients with chronic low back pain.
Scientific Title:Acronym Immediate Effect of acupuncture on sensitized tissue.
Region
Japan

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

Objectives
Narrative objectives1 Investigation of the immediate effect of acupuncture on sensitized tissues in patients with low back pain
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Pressure pain threshold
Key secondary outcomes Pressure pain rating
Temporal summation
Visual Analog Scale

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Deep acupuncture
Interventions/Control_2 Shallow 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 1) chronic low back pain lasting 3 month or more
2) Patients with localized pressure pain on lumbar part
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 50

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
2020 Year 12 Month 01 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
2020 Year 10 Month 21 Day
Date of IRB
2020 Year 10 Month 21 Day
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2022 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
2020 Year 11 Month 27 Day
Last modified on
2021 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048593

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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