UMIN-CTR Clinical Trial

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
Email	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
Email	hisyohayaishi@gmail.com

Sponsor
Institute	Hayaishi Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043184