UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006246
Receipt number R000006792
Scientific Title Operability assessment of integrative medicine for posttraumatic residual disability
Date of disclosure of the study information 2011/09/12
Last modified on 2014/08/31 23:56:49

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Basic information

Public title

Operability assessment of integrative medicine for posttraumatic residual disability

Acronym

Operability assessment of integrative medicine for posttraumatic residual disability

Scientific Title

Operability assessment of integrative medicine for posttraumatic residual disability

Scientific Title:Acronym

Operability assessment of integrative medicine for posttraumatic residual disability

Region

Japan


Condition

Condition

Posttraumatic residual disability

Classification by specialty

Psychiatry Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

First objective is operability assessment of integrated medicine (included acupuncture and aroma massage) for patients who have posttraumatic residual disability. Second objective is Efficasy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

persistency rate in each intervention

Key secondary outcomes

change of clinical score for QOL, physical distress and mental distress


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

acupancture and psychological treatment

Interventions/Control_2

aroma massage and psychological treatment

Interventions/Control_3

Yoga therapy and psychological treatment

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

People who met accidental trauma more than three years and have residual physical distress

Key exclusion criteria

People who have cognitive disorder (delirium, dementia and so on), schizophrenia or bipolar disorder.
People who need general medical treatment because of acute phase.
People who have a bad prognosis.
People who cannnot read and write Japanese.

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshinori Ito

Organization

Osaka University Graduate school of Medicine

Division name

Depertment of Complementary and Alternative Medicine

Zip code


Address

G9, 2-2, Yamadaoka, Suita Osaka, Japan

TEL

06-6879-3498

Email

n-hayashi@cam.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriyuki Hayashi

Organization

Osaka University Graduate school of Medicine

Division name

Depertment of Complementary and Alternative Medicine

Zip code


Address

G9, 2-2, Yamadaoka, Suita Osaka, Japan

TEL

06-6879-3498

Homepage URL


Email

n-hayashi@cam.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University Graduate school of Medicine, Depertment of Complementary and Alternative Medicine

Institute

Department

Personal name



Funding Source

Organization

Osaka University Graduate school of Medicine, Depertment of Complementary and Alternative Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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(大阪府)


Other administrative information

Date of disclosure of the study information

2011 Year 09 Month 12 Day


Related information

URL releasing protocol

http://osaka-cam.jp/wp-content/uploads/20120807.pdf

Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Background: Survivors from disasters often have physical and mental distress for prolonged periods. They often ask
for help of Complementary and Alternative Medicine (CAM). It was reported that people who have both physical and
mental distress are often resistant to general insurance medical care.
Methods: This intervention was performed at Osaka University Hospital for post-traumatic residual disability. Primary
outcome is persistency rate. Secondary outcomes are change of clinical score for severity of PTSD (IES-R: Impact of
Event Scale-Revised) and depression (PHQ-9: Patient Health Questionnare-9), Satisfaction for interventions, physical
and mental distress (VAS: Visual Analog Scale), etc.
Selectable intervention (acupuncture and/or aroma treatment) was performed once a week for 8 weeks.
Results: All 9 participants selected both interventions (acupuncture and aroma treatment) , and completed the
interventions. No severe adverse event was occurred. Just after intervention, both physical and mental distress were
significantly improved. Through the intervention, both physical and mental distress were not improved, especially in
PTSD like people. Through the intervention, depression scale were significantly improved.

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

Main results already published

Date of protocol fixation

2011 Year 07 Month 13 Day

Date of IRB


Anticipated trial start date

2011 Year 09 Month 12 Day

Last follow-up date

2013 Year 08 Month 01 Day

Date of closure to data entry

2013 Year 12 Month 01 Day

Date trial data considered complete

2013 Year 12 Month 01 Day

Date analysis concluded

2014 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 08 Month 29 Day

Last modified on

2014 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006792


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name