UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the efficacy of mindfulness training for chronic pain.
Title of the study (Brief title)	Study on the efficacy of mindfulness training for chronic pain.
Region	Japan

Condition
Condition	Chronic pain
Classification by specialty	Psychosomatic Internal Medicine Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the efficacy of mindfulness training psychotherapy for chronic pain.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Pain intensity, Life disturbance
Key secondary outcomes	Pain Quality, Pain catastrophizing, Depression, Anxiety, Mindfulness, Quality of life.

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	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	Mindfulness training
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Chronic pain outpatient
Key exclusion criteria	Major depression, bipolar disturbance, personality disturbance, drug abuse, history of suiside, cancer pain, neuropathic pain.
Target sample size	20

Research contact person
Name of lead principal investigator	Masafumi Tashiro
Organization	Kumamoto University Hospital
Division name	Dept of Anesthesiology
Address	1-1-1 Honjo, chuou-ku, Kumamoto
TEL	096-344-2111
Email	m-tashiro@kuh.kumamoto-u.ac.jp

Public contact
Name of contact person	Masafumi Tashiro
Organization	Kumamoto University Hospital
Division name	Dept of Anesthesiology
Address	1-1-1 Honjo, chuou-ku, Kumamoto
TEL	096-344-2111
Homepage URL
Email	m-tashiro@kuh.kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University Hospital
Institute
Department

Funding Source
Organization	Kumamoto University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	熊本大学医学部附属病院（熊本県）

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 10 Day
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 05 Day
Last modified on	2017 Year 06 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031662