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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034825
Receipt No. R000039716
Scientific Title Evaluation of Tasuki-style Supporter for Neck Pain(TAsuki-style SUpporter for necK paIn; TASUKI-W study): randomized, waiting-list-controlled trial
Date of disclosure of the study information 2018/11/13
Last modified on 2019/04/17

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Basic information
Public title Evaluation of Tasuki-style Supporter for Neck Pain(TAsuki-style SUpporter for necK paIn; TASUKI-W study): randomized, waiting-list-controlled trial
Acronym TASUKI-W study
Scientific Title Evaluation of Tasuki-style Supporter for Neck Pain(TAsuki-style SUpporter for necK paIn; TASUKI-W study): randomized, waiting-list-controlled trial
Scientific Title:Acronym TASUKI-W study
Region
Japan

Condition
Condition Neck pain
Classification by specialty
Orthopedics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of tasuki-style supporter on neck pain compared with waiting-list
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes modified Neck Disability Index after one week
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Use a tasuki-style supporter daily 5 minutes or longer
Interventions/Control_2 Waiting list
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 modified Neck Disability Index 10 or more
Key exclusion criteria No organic disease diagnosed around the neck or the shoulder
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mizuno Hiromoto
Organization Minami Seikyo Hospital
Division name Medical Office
Zip code
Address 2-204, Minami-Odaka, Midori-ku, Nagoya, Aichi 459-8540, Japan
TEL 052-625-0373
Email ikyoku-jimukyoku2@minami.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Furukawa Yuki
Organization Minami Seikyo Hospital
Division name Medical Office
Zip code
Address 2-204, Minami-Odaka, Midori-ku, Nagoya, Aichi 459-8540, Japan
TEL 052-625-0373
Homepage URL
Email ikyoku-jimukyoku2@minami.or.jp

Sponsor
Institute Minami Seikyo Hospital
Institute
Department

Funding Source
Organization None
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
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
2018 Year 11 Month 13 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 50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
50 participants (mean age, 40.9 [SD=9.6]; 32 participants [64%] were female, mean mNDI, 14.3 [SD=2.9]) 
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 13 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
2018 Year 11 Month 08 Day
Last modified on
2019 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039716

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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