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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035149
Receipt No. R000040059
Official scientific title of the study The relation between pain intensity and disability: assessment by the 12-item World Health Organization Disability Assessment Schedule 2.0
Date of disclosure of the study information 2018/12/06
Last modified on 2018/12/05

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Basic information
Official scientific title of the study The relation between pain intensity and disability: assessment by the 12-item World Health Organization Disability Assessment Schedule 2.0
Title of the study (Brief title) The relation between pain intensity and disability: assessment by the 12-item World Health Organization Disability Assessment Schedule 2.0
Region
Japan

Condition
Condition pain
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the relation between pain intensity and disability with WHODAS2.0.
Basic objectives2 Others
Basic objectives -Others To assess the change of disability with therapies in pain clinic.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes pain intensity (NRS) and disability (WHODAS2.0). they were interviewed on baseline, 1,3,6,12 months after registrasion.
Key secondary outcomes 1. Euro QOL 5D5L Japanese version
2. Functional Independence Measure
3. Hospital Anxiety and Depression Scale
4. Pain Catastrophizing Scale
5. the habit of regular exercise
6. Perceived Stress Scale Japanese version

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
50 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria the patients with pain who is over 50 years old
Key exclusion criteria The patient who can not answer the Questionnaires, for example, who can not understand Japanese, who has severe dementia or intellectual disability.
Target sample size 1000

Research contact person
Name of lead principal investigator Aki Fujiwara
Organization Nara Medical University
Division name Anesthesiology
Address 840 shijo-cho, Kashihara, Nara
TEL +81-744-29-8902
Email higemo1117@yahoo.co.jp

Public contact
Name of contact person Aki Fujiwara
Organization Nara Medical University
Division name Anesthesiology
Address 840 shijo-cho, Kashihara, Nara
TEL +81-744-29-8902
Homepage URL
Email higemo1117@yahoo.co.jp

Sponsor
Institute Nara Medical University, Department of Anesthesiology
Institute
Department

Funding Source
Organization Nara Medical University, Department of Anesthesiology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 奈良県立医科大学附属病院(奈良県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 06 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 12 Month 05 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information This study is an observational study for all patients with pain.

Management information
Registered date
2018 Year 12 Month 05 Day
Last modified on
2018 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040059

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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