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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042615
Receipt No. R000048564
Scientific Title Multidimensional Objective Measurement for Pain with Ecological Momentary Assessment
Date of disclosure of the study information 2021/01/11
Last modified on 2020/11/30

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Basic information
Public title Multidimensional Objective Measurement for Pain with Ecological Momentary Assessment
Acronym MOM Pain EMA
Scientific Title Multidimensional Objective Measurement for Pain with Ecological Momentary Assessment
Scientific Title:Acronym MOM Pain EMA
Region
Japan

Condition
Condition Chronic Primary Pain or Chronic Secondary Musculoskeletal Pain
Classification by specialty
Orthopedics Anesthesiology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Our objective is to examine the association between pain intensity and physical activity measures in individuals with chronic primary pain or chronic secondary musculoskeletal pain.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the association between pain intensity and physical activity measures in individuals with chronic primary pain or chronic secondary musculoskeletal pain
Key secondary outcomes The association between pain intensity measured by the EMA and pain sensitization measured by pQST.
The intraday variability of subjective symptoms (e.g., pain, stress, depressive mood) measured by the EMA.
The interrelationships among subjective symptoms measured by the EMA.
The associations between subjective symptoms measured by the EMA and questionnaire scores.
The intraday variability of physical activity measured by the wearable accelerometer.
The associations between subjective symptoms measured by the EMA and physical activity measured by the wearable accelerometer.
The associations between physical activity measured by the wearable accelerometer and questionnaire scores.

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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Chronic Primary Pain or Chronic Secondary Musculoskeletal Pain.
Lasting pain over three months at registration.
Key exclusion criteria Comorbid conditions of infection, trauma, and other acute inflammatory conditions.
The severe decline of cognitive function such as dementia.
Having a skin disorder at the inspection site of pQST.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Sei
Middle name
Last name Fukui
Organization Shiga University of Medical Science
Division name Pain Management Clinic
Zip code 520-2192
Address Seta Tsukinowa-cho, Otsu, Shiga
TEL 077-548-2582
Email sei@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name Sei
Middle name
Last name Fukui
Organization Shiga University of Medical Science
Division name Pain Management Clinic
Zip code 520-2192
Address Seta Tsukinowa-cho, Otsu, Shiga
TEL 077-548-2582
Homepage URL
Email sei@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Shiga University of Medical Science Research Ethics Committee
Address Shiga University of Medical Science Hospital, Seta Tsukinowa-cho, Otsu, Shiga
Tel 077-548-3576
Email hqrec@belle.shiga-med.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

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 11 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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 27 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 04 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information *Examination Items
Actigraph
Ecological Momentary Assessment(EMA) using the smartphone.
Practical Quantitative Sensory Testing (pQST)
Patient Background
Study Questionnaires:
Beck Depression Inventory(BDI),
State-Trait Anxiety Inventory(STAI),
Numerical Rating Scale(NRS),
Pain Disability Assessment Scale(PDAS),
Pattern of Activity Measure-Pain(POAM-P),
Pain Catastrophizing Scale short form(PCS6),
Pain Self-efficacy Questionnaire short form(PSEQ4)

Management information
Registered date
2020 Year 12 Month 01 Day
Last modified on
2020 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048564

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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