UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034246
Receipt number R000039011
Scientific Title Evaluation of Tasuki-style Supporter for Neck Pain(TAsuki-style SUpporter for necK paIn; TASUKI study): randomized control trial
Date of disclosure of the study information 2018/09/26
Last modified on 2020/03/26 12:33:18

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Basic information

Public title

Evaluation of Tasuki-style Supporter for Neck Pain(TAsuki-style SUpporter for necK paIn; TASUKI study): randomized control trial

Acronym

TASUKI study

Scientific Title

Evaluation of Tasuki-style Supporter for Neck Pain(TAsuki-style SUpporter for necK paIn; TASUKI study): randomized control trial

Scientific Title:Acronym

TASUKI 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

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

Active

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

Exercise for neck pain daily

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

10


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 or person

Institute

Minami Seikyo Hospital

Institute

Department

Personal name



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 09 Month 26 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

Between Oct 9, 2018, and Oct 12, 2018, we enrolled and randomly allocated 10 participants (mean mNDI 12.2+-1.6. to the exercise alone and 5 to exercise combined with wearing tasuki-style supporter), all of whom completed the one-week primary outcome assessment. There was no statistically significant difference between the groups (-5 vs -3.6. Two-sided t-test: p=0.28).

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

2018 Year 09 Month 15 Day

Date of IRB

2018 Year 09 Month 24 Day

Anticipated trial start date

2018 Year 09 Month 25 Day

Last follow-up date

2019 Year 04 Month 16 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 23 Day

Last modified on

2020 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039011


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name