UMIN-CTR Clinical Trial

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
Institute	Department of psychosomatic medicine, Kansai Medical University Graduate School
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038773