UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037881 |
|---|---|
| Receipt number | R000043184 |
| Scientific Title | An observational study on treatment course in patients with whiplash-associated disorders |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2019/09/01 11:31:55 |
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Basic information
Public title
An observational study on treatment course in patients with whiplash-associated disorders
Acronym
Treatment course of whiplash-associated disorders
Scientific Title
An observational study on treatment course in patients with whiplash-associated disorders
Scientific Title:Acronym
Treatment course of whiplash-associated disorders
Region
| Japan |
Condition
Condition
Whiplash-associated disorders
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to investigate the predictive factors for treatment outcome in patients with whiplash-associated disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to claim closure, Number of treatment visits
Key secondary outcomes
Numeric Rating Scale (NRS), Neck Disability Index (NDI), Hospital Anxiety and Depression Scale (HADS), Injustice Experiences Questionnaire (IEQ), Euro Qol five-dimensional questionnaire (EQ-5D)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Whiplash-associated disorders
Key exclusion criteria
Previous neck injury, Ongoing treatment for pain or pain related symptoms
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Miki |
Organization
Hayaishi Hospital
Division name
Center for pain management
Zip code
543-0027
Address
2-75 Fudegasaki Tennoji, Osaka, Japan
TEL
06-6771-1227
hisyohayaishi@gmail.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Miki |
Organization
Hayaishi Hospital
Division name
Center for pain management
Zip code
543-0027
Address
2-75 Fudegasaki Tennoji, Osaka, Japan
TEL
06-6771-1227
Homepage URL
hisyohayaishi@gmail.com
Sponsor or person
Institute
Hayaishi Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Hayaishi Hospital
Address
2-75 Fudegasaki Tennoji, Osaka, Japan
Tel
06-6771-1227
info@hayaishi.or.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
| 2019 | Year | 09 | 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
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of the present study is to investigate the predictive factors for treatment outcome in patients with whiplash-associated disorders.
Management information
Registered date
| 2019 | Year | 09 | Month | 01 | Day |
Last modified on
| 2019 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043184
