UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034825 |
|---|---|
| Receipt number | 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 | 2019/11/10 11:21:35 |
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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
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
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
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
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1002/1348-9585.12097
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
Main results already published
Date of protocol fixation
| 2018 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 15 | 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 | 11 | Month | 08 | Day |
Last modified on
| 2019 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039716
