UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019240 |
|---|---|
| Receipt number | R000022228 |
| Scientific Title | The effect of psycho-social approach for chronic pain patients. |
| Date of disclosure of the study information | 2015/10/05 |
| Last modified on | 2024/03/29 16:39:58 |
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Basic information
Public title
The effect of psycho-social approach for chronic pain patients.
Acronym
The effect of psycho-social approach for chronic pain patients.
Scientific Title
The effect of psycho-social approach for chronic pain patients.
Scientific Title:Acronym
The effect of psycho-social approach for chronic pain patients.
Region
| Japan |
Condition
Condition
Chronic pain
Classification by specialty
| Neurology | Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the efficacy of the psycho-social approach for patients with chronic pain through comparing treatment as usual(TAU)group and TAU+psycho-social group on pain intensity and psycho social factors(ex. degree of pain related difficulty on daily life, depression, anxiety, insomnia, self-efficacy, QOL, etc.).
This study also examines how psychological factors at baseline would affect pain related difficulty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Participants complete following questionnaires at baseline and 1, 3, 6 months.
1.Pain Disability Assessment Scale(PDAS)
2.Hospital Anxiety and Depression Scale(HADS)
3.Pain Catastrophizing Scale(PCS)
4.Pain Self-Efficacy Questionnaire(PSEQ)
Key secondary outcomes
Participants complete following questionnaires at baseline(1-6)and 1, 3, 6 months(1-5).
1.Brief Pain Inventory(BPI)
2.Athens Insomnia Scale(AIS)
3.EuroQol 5 Dimension(EQ5D)
4.Locomo25
5.The short of the Japanese version of the Zarit Caregiver Burden Interview
6.Demographic Data:disease name, age, sex, medication, height and weight, employment status etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Treatment as usual condition
implementation period:2015/10-2017/3
intervention :standard medical care from the doctor
Interventions/Control_2
treatment as usual and cognitive behavioral approach condition
implementation period:2015/10-2017/3
interventions:standard medical care from the doctor and tailor made cognitive behavioral approach from psychotherapist
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
･existence of daily-life difficulty caused by pain
･experiencing pain for at least 3 months
･score of DIT(distress and impact thermometer) is over cut-off points
･who have written consent to participate in this research
Key exclusion criteria
･to be judged inappropriate to this research by attending physician
･patients who refuse to participate in this study
･patients who have diagnosed Mental retardation, Developmental disorder
･patients who have language disorder
･who have substance abuse
･patients who require surgical intervention
･patients whose pain is because of inflammation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Kotegawa |
Organization
Ehime University School of Medicine & Ehime University Hospital
Division name
Total medical support center
Zip code
791-0295
Address
454, Shitsukawa,Toon,791-0295 Japan
TEL
089-960-5917
kotegawa@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Kotegawa |
Organization
Ehime University School of Medicine & Ehime University Hospital
Division name
Total medical support center
Zip code
791-0295
Address
454 Shitsukawa,Toon,791-0295 Japan
TEL
089-960-5917
Homepage URL
kotegawa@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University School of Medicine & Ehime University Hospital
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grant
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
Ehime University School of Medicine & Ehime University Hospital
Address
454 Shitsukawa,Toon,791-0295 Japan
Tel
089-960-5917
kotegawa@m.ehime-u.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
| 2015 | Year | 10 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2020 | 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
| 2015 | Year | 10 | Month | 05 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022228
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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