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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020880
Receipt No. R000024091
Scientific Title The efficacy of cognitive behavioral therapy for chronic pain: a pilot study
Date of disclosure of the study information 2016/02/05
Last modified on 2019/08/08

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Basic information
Public title The efficacy of cognitive behavioral therapy for chronic pain: a pilot study
Acronym The study of cognitive behavioral therapy for chronic pain
Scientific Title The efficacy of cognitive behavioral therapy for chronic pain: a pilot study
Scientific Title:Acronym The study of cognitive behavioral therapy for chronic pain
Region
Japan

Condition
Condition chronic pain
Classification by specialty
Medicine in general Neurology Clinical immunology
Psychosomatic Internal Medicine Orthopedics Anesthesiology
Rehabilitation medicine Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this research is to examine the effects of cognitive behavioral therapy for chronic pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes EQ-5D-5L
Evaluations are performed at baseline, end of the CBT treatment, and 6-month follow-up.
Key secondary outcomes SF-12
Numerical Rating Scale
Pain Disability Assessment Scale
Patient Health Questionnaire-9
Pain Catastrophizing Scale
Tampa Scale for Kinesiophobia eleven
Pain Self-Efficacy Questionnaire
Keele STarT Back Screening Tool generic condition
Somatic Symptom Scale-8

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 A 30-min treatment program of cognitive behavioral therapy is conducted eight times. The interval between sessions is one or two weeks.
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 1. patients who have daily-life difficulty caused by chronic pain for at least three months
2. patients who consent to participate in the research
Key exclusion criteria 1. patients who have need medical treatment rapidly
2. patients who have alcohol abuse or drug abuse
3. patients who have mental disease such as hypomania, mania, psychotic disorder
4. patients who have significant suicidal ideation
5. patients who have cognitive dysfunction such as delirium, dementia, mental retardation
6. patients who are difficult to communicate with Japanese
7. patients who have chronic pain because of accident or surgery
8. patients who have compensation or suits
9. patients who select 10 score in numerical rating scale
10. patients who are judged inappropriate to the research by the attending physician
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Masahiko
Middle name
Last name Shibata
Organization Naragakuen University
Division name Faculty of Health Science
Zip code 6318524
Address 3-15-1 Tomigaoka, Nara-shi, Nara, 631-8524, Japan
TEL 0742-95-9800
Email mshibata@naragakuen.jp

Public contact
Name of contact person
1st name Masahiko
Middle name
Last name Shibata
Organization Naragakuen University
Division name Faculty of Health Science
Zip code 6318524
Address 3-15-1 Tomigaoka, Nara-shi, Nara, 631-8524, Japan
TEL 0742-95-9800
Homepage URL
Email mshibata@naragakuen.jp

Sponsor
Institute Faculty of Health Science Naragakuen University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development(AMED)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Osaka University Clinical Research Review Committee
Address 2-2 Yamadaoka Suita Osaka Japan 565-0871
Tel 06-6210-8289
Email mirai@hp-mctr.med.osaka-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 篤友会千里山病院(大阪府)
国立精神・神経医療研究センター 認知行動療法センター(東京都)
東京慈恵医科大学麻酔科ペインクリニック(東京都)
川﨑医科大学附属病院麻酔・集中治療科(岡山県)
神戸大学医学部附属病院麻酔科・ペインクリニック科(兵庫県)

Other administrative information
Date of disclosure of the study information
2016 Year 02 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 Completed
Date of protocol fixation
2016 Year 02 Month 04 Day
Date of IRB
2016 Year 03 Month 17 Day
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2018 Year 01 Month 23 Day
Date of closure to data entry
2018 Year 01 Month 23 Day
Date trial data considered complete
2018 Year 01 Month 23 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 02 Month 04 Day
Last modified on
2019 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024091

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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