UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042615 |
|---|---|
| Receipt number | 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 | 2024/04/02 12:49:37 |
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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
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
sei@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 11 | Day |
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
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048564
