UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043174
Receipt number R000049282
Scientific Title The relation between the state of emergency because of COVID-19 and disability in patients with chronic pain.
Date of disclosure of the study information 2021/02/01
Last modified on 2021/12/22 12:16:42

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Basic information

Public title

The relation between the state of emergency because of COVID-19 and disability in patients with chronic pain.

Acronym

The relation between the state of emergency because of COVID-19 and disability in patients with chronic pain.

Scientific Title

The relation between the state of emergency because of COVID-19 and disability in patients with chronic pain.

Scientific Title:Acronym

The relation between the state of emergency because of COVID-19 and disability in patients with chronic pain.

Region

Japan


Condition

Condition

chronic pain. We use the data from the study "The relation between pain intensity and disability: assessment by the 12-item World Health Organization Disability Assessment Schedule 2.0"(UMIN000035149)

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of the state of emergency because of COVID-19 on disability of patients with chronic pain.

Basic objectives2

Others

Basic objectives -Others

To examine the the effect of the state of emergency on psychological factors and habits of exercise.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

the change of disability

Key secondary outcomes

the change of psychological factors and habit of exercise


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 chronic pain who is over 50 years old. the patients who could complete the baseline questionnaire by December 2019.

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

400


Research contact person

Name of lead principal investigator

1st name Kie
Middle name
Last name Yoshimura

Organization

Nara Medical University

Division name

the department of Anesthesiology

Zip code

6348522

Address

840, Shijocho Kashihara Nara

TEL

+81744298902

Email

kiepon@yahoo.co.jp


Public contact

Name of contact person

1st name Aki
Middle name
Last name Fujiwara

Organization

Nara Medical University

Division name

the department of Anesthesiology

Zip code

6348522

Address

840, Shijocho Kashihara Nara

TEL

+81744298902

Homepage URL


Email

kiepon@yahoo.co.jp


Sponsor or person

Institute

Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

Nara Medical University

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, Shijocho Kashihara Nara

Tel

+81744298902

Email

getakko@hotmail.com


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

2021 Year 02 Month 01 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1007/s00540-021-02992-y

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s00540-021-02992-y

Number of participants that the trial has enrolled

245

Results

Of the 245 eligible patients, there was no significant disability difference between baseline, pre-pandemic, and during the pandemic (p = 0.14). Similarly, pain intensity, health-related QOL, anxiety, depression, and the presence/absence of exercise habits did not significantly differ between baseline, pre-pandemic, and during the pandemic either. The current study observed significant differences in terms of catastrophic thinking (p = 0.02).

Results date posted

2021 Year 12 Month 22 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 08 Month 25 Day

Baseline Characteristics

The patients with chronic pain receiving treatment at the Pain Center of Nara Medical University Hospital. The patients had completed questionnaires for a disability during the study period, from 1 July to 30 September 2019 (baseline), 1 October to 31 December 2019 (pre-pandemic), and 1 July to 30 September 2020 (during the pandemic).

Participant flow


Adverse events

none

Outcome measures

NRS, 12item-WHODAS2.0, HADS, PCS, EQ5D5L, habits of exercise

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 01 Month 29 Day

Date of IRB

2021 Year 04 Month 01 Day

Anticipated trial start date

2021 Year 01 Month 29 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study would analyze the data from prospective observational study "The relation between pain intensity and disability: assessment by the 12-item World Health Organization Disability Assessment Schedule 2.0"(UMIN000035149) retrospectively.


Management information

Registered date

2021 Year 01 Month 29 Day

Last modified on

2021 Year 12 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049282


Research Plan
Registered date File name
2021/12/22 研究計画書.pdf

Research case data specifications
Registered date File name
2021/12/22 質問票.docx

Research case data
Registered date File name
2021/12/22 全データ.xlsx