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 2020/11/30 11:23:48

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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

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

Value
https://center6.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