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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025467
Receipt No. R000029309
Scientific Title The change in blood flow and hardness of the trapezius-muscle after low reactive level laser irradiation on the stellate ganglion or stellate ganglion block
Date of disclosure of the study information 2017/01/01
Last modified on 2016/12/28

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Basic information
Public title The change in blood flow and hardness of the trapezius-muscle after low reactive level laser irradiation on the stellate ganglion or stellate ganglion block
Acronym The change in blood flow and hardness of muscle after low reactive level laser irradiation on the stellate ganglion or stellate ganglion block
Scientific Title The change in blood flow and hardness of the trapezius-muscle after low reactive level laser irradiation on the stellate ganglion or stellate ganglion block
Scientific Title:Acronym The change in blood flow and hardness of muscle after low reactive level laser irradiation on the stellate ganglion or stellate ganglion block
Region
Japan

Condition
Condition Tension-type headache
Classification by specialty
Medicine in general Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The change in blood flow and hardness of the trapezius-muscle after low reactive level laser irradiation on the stellate ganglion or stellate ganglion block
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between change in trapezius-muscle blood volume measured by near-infrared spectroscopy and change in trapezius-muscle hardness during low reactive level laser irradiation on the stellate ganglion or stellate ganglion block
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Tension-type headache patients undergoing low reactive level laser irradiation on the stellate ganglion or stellate ganglion block
Key exclusion criteria Patients with severe systemic complication
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Kondo
Organization Nihon University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 30-1,Oyaguchi-Kamicho,Itabashi-ku,Tokyo
TEL 03-3972-8111
Email kondo.yuko@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Kondo
Organization Nihon University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 30-1,Oyaguchi-Kamicho,Itabashi-ku,Tokyo
TEL 03-3972-8111
Homepage URL
Email kondo.yuko@nihon-u.ac.jp

Sponsor
Institute Nihon University School of Medicine
Institute
Department

Funding Source
Organization Nihon University School of 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 01 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 Completed
Date of protocol fixation
2015 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design : Observational study (Case-control study)
Participants : Tension-type headache patients undergoing low reactive level laser irradiation on the stellate ganglion or stellate ganglion block from June 2015 to June 2016
Observation items : Relationship between change in trapezius-muscle blood volume and change in trapezius-muscle hardness during low reactive level laser irradiation on the stellate ganglion or stellate ganglion block

Management information
Registered date
2016 Year 12 Month 28 Day
Last modified on
2016 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029309

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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