UMIN-CTR Clinical Trial

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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