UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035149
Receipt number R000040059
Scientific Title 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 2019/04/04 09:25:37

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Basic information

Public title

The relation between pain intensity and disability: assessment by the 12-item World Health Organization Disability Assessment Schedule 2.0

Acronym

The relation between pain intensity and disability: assessment by the 12-item World Health Organization Disability Assessment Schedule 2.0

Scientific Title

The relation between pain intensity and disability: assessment by the 12-item World Health Organization Disability Assessment Schedule 2.0

Scientific Title:Acronym

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

1st name Aki
Middle name
Last name Fujiwara

Organization

Nara Medical University

Division name

Anesthesiology

Zip code

6348521

Address

840 shijo-cho, Kashihara, Nara

TEL

+81-744-29-8902

Email

higemo1117@yahoo.co.jp


Public contact

Name of contact person

1st name Aki
Middle name
Last name Fujiwara

Organization

Nara Medical University

Division name

Anesthesiology

Zip code

6348521

Address

840 shijo-cho, Kashihara, Nara

TEL

+81-744-29-8902

Homepage URL

http://www.naramed-u.ac.jp/~anes/

Email

higemo1117@yahoo.co.jp


Sponsor or person

Institute

Nara Medical University, Department of Anesthesiology

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization

Nara Medical University Ethics Committee

Address

840 shijo-cho, Kashihara, Nara

Tel

+81744298902

Email

ino_rinri@naramed-u.ac.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

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


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

2018 Year 12 Month 05 Day

Date of IRB

2018 Year 12 Month 17 Day

Anticipated trial start date

2019 Year 04 Month 02 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2023 Year 03 Month 31 Day

Date trial data considered complete

2023 Year 03 Month 31 Day

Date analysis concluded

2024 Year 03 Month 31 Day


Other

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

2019 Year 04 Month 04 Day



Link to view the page

Value
https://center6.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