UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034006
Receipt number R000038773
Scientific Title Psychosomatic study on subjective assessment of physical activity in chronic pain patients
Date of disclosure of the study information 2018/09/04
Last modified on 2021/08/15 11:36:19

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Basic information

Public title

Psychosomatic study on subjective assessment of physical activity in chronic pain patients

Acronym

Psychosomatic study on subjective assessment of physical activity in chronic pain patients

Scientific Title

Psychosomatic study on subjective assessment of physical activity in chronic pain patients

Scientific Title:Acronym

Psychosomatic study on subjective assessment of physical activity in chronic pain patients

Region

Japan


Condition

Condition

chronic pain

Classification by specialty

Psychosomatic Internal Medicine Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We clarified the degree of difference between physical activity by objective measuring instruments and physical activity by subjective scale and the relationship between psychological characteristics and introceptive awareness in chronic pain patients, We will consider the support of effective physical activity for future chronic pain patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

physical activity
Accelerometer(ActiGraph GT3X-BT ActiGraph LLC, Pensacola, FL, USA)
Questionnaire(The International Physical Activity Questionnaire Short Form)

Key secondary outcomes

psychological assessment
heartbeat tracking task


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

1 Basic information of research subject: Gender, age, disease, illness period, BMI, education history, preference, medication situation, surgical history, marital status

2 Cognitive function test: MMSE (Mini Mental State Examination)

3 Heartbeat tracking task

4 Objective physical activity measurement: Accelerometer(ActiGraph GT3X-BT ActiGraph LLC, Pensacola, FL, USA)

5 Psychological assessment :Short-Form McGill Pain Questionnaire(SF-MPQ), Pain Self Efficacy Questionnaire(PSEQ), Hospital Anxiety and Depression Scale(HADS), Pain Catastrophizing Scale(PCS), Toront Alexithymia Scale 20(TAS-20), Chronic Pain Acceptance Questionnaire(CPAQ), The Somatosensory Amplification Scale(SSAS), SF-8, Sense of Coherence scale(SOC)

6 Subjective Physical Activity Scale:The International Physical Activity Questionnaire Short Form(IPAQ-SF)

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1 Persons whose age is 20 years or older at the time of acquiring consent
2 After receiving sufficient explanation for participation in this research, those who gained consent from the research subjects' free will with sufficient understanding

Key exclusion criteria

1 Persons who has a decline in cognitive function
2 Persons with arrhythmia
3 Those whose mental illness is the main disease name
4 Persons who lack ability to express intention
5 Other,those who have judged that the research director is inappropriate as the research subject

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisaharu Shizuma

Organization

Kansai Medical University Graduate School

Division name

department of psychosomatic medicine

Zip code


Address

2-5-1 Shin-machi, Hirakata City, Osaka 573-0101 Japan

TEL

072-804-0101

Email

shizumah@hirakata.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hisaharu Shizuma

Organization

Kansai Medical University Graduate School

Division name

department of psychosomatic medicine

Zip code


Address

2-5-1 Shin-machi, Hirakata City, Osaka 573-0101 Japan

TEL

072-804-0101

Homepage URL


Email

shizumah@hirakata.kmu.ac.jp


Sponsor or person

Institute

Department of psychosomatic medicine, Kansai Medical University Graduate School

Institute

Department

Personal name



Funding Source

Organization

Department of psychosomatic medicine, Kansai Medical University Graduate School

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Hankai Hospital
Kyoto College of Medical Health

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 09 Month 04 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

Main results already published

Date of protocol fixation

2018 Year 04 Month 16 Day

Date of IRB

2018 Year 01 Month 04 Day

Anticipated trial start date

2018 Year 09 Month 05 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



Management information

Registered date

2018 Year 09 Month 03 Day

Last modified on

2021 Year 08 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038773


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name