UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Operability assessment of integrative medicine for refractory chronic pain
Title of the study (Brief title)	Operability assessment of integrative medicine for refractory chronic pain
Region	Japan

Condition
Condition	refractory chronic pain
Classification by specialty	Neurology Psychosomatic Internal Medicine Psychiatry Orthopedics Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To see operability of integrative medicine as combination of CAMs (Complementary and Alternative Medicines) for patients of refractory chronic pain
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	participation ratio of each CAM
Key secondary outcomes	fMRI,salivary amylase, salivary cortisol, salivary HHV6-7, actigraph, PAINVISION, TAS9, NRS(Numerical Rating Scale), FFMQ(Five Facet Mindfulness Questionnaire), Alexisomia scale, iPAD common assessment system

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 Maneuver
Interventions/Control_1	We intervene Acupancture, Aromatherapy, Mindfulness cognitive therapy or Yogatherapy with patients select, weekly for 8 weeks. multiple selections are allowable.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Chronic pain continues more than 3 months.
Key exclusion criteria	Severe illness (mental or physical)
Target sample size	30

Research contact person
Name of lead principal investigator	Noriyuki Hayashi
Organization	Osaka University Graduate School of Medicine
Division name	Department of Integrative Medicine
Address	G9, 2-2, Yamadaoka, Suita, Osaka 565-0871 Japan
TEL	+81668793498
Email	n-hayashi@cam.med.osaka-u.ac.jp

Public contact
Name of contact person	Noriyuki Hayashi
Organization	Osaka University Graduate School of Medicine
Division name	Department of Integrative Medicine
Address	G9, 2-2, Yamadaoka, Suita, Osaka 565-0871 Japan
TEL	+81668793498
Homepage URL
Email	n-hayashi@cam.med.osaka-u.ac.jp

Sponsor
Institute	Department of Integrative Medicine, Osaka University Graduate School of Medicine
Institute
Department

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

Other related organizations
Co-sponsor	Department of Pain Medicine, Osaka University Graduate School of Medicine
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	大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 09 Day
Anticipated trial start date	2015 Year 11 Month 06 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://waza-sophia.la.coocan.jp/data/nennpou/nennpou63.pdf
Results
Other related information

Management information
Registered date	2015 Year 09 Month 11 Day
Last modified on	2017 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020643