UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012637
Receipt number R000014780
Scientific Title Research on the system of acupuncture treatment and objective assessment of acupuncture intervention in palliative care unit
Date of disclosure of the study information 2013/12/20
Last modified on 2013/12/20 13:59:16

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Basic information

Public title

Research on the system of acupuncture treatment and objective assessment of acupuncture intervention in palliative care unit

Acronym

Research on objective assessment of acupuncture intervention in palliative care

Scientific Title

Research on the system of acupuncture treatment and objective assessment of acupuncture intervention in palliative care unit

Scientific Title:Acronym

Research on objective assessment of acupuncture intervention in palliative care

Region

Japan


Condition

Condition

palliative care

Classification by specialty

Medicine in general

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To consider acupuncture effects on a various complaints in palliative care.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Analgesic effect

Key secondary outcomes

Improvement of symptoms
Usage of analgesics
Adverse event
Patients' satisfaction for treatment


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

Other

Interventions/Control_1

acupuncture and moxibustion

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

Referral from the attending physician

Key exclusion criteria

Consciousness loss

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name SHOJI SHINOHARA

Organization

Meiji University of Integrative Medicine

Division name

Acupuncture and Moxibustion

Zip code


Address

Hiyoshi-cyo Nantan-city Kyoto

TEL

+81-771-72-1181

Email

keiraku.research@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name SHOJI SHINOHARA

Organization

Meiji University of Integrative Medicine

Division name

Acupuncture and Moxibustion

Zip code


Address

Hiyoshi-cyo Nantan-city Kyoto

TEL

+81-771-72-1181

Homepage URL


Email

keiraku.research@gmail.com


Sponsor or person

Institute

Meiji University of Integrative Medicine

Institute

Department

Personal name



Funding Source

Organization

grants of the research expenses of the Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

市立福知山市民病院


Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 20 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

The study examined 25 patients who underwent acupuncture therapy at the request of their attending physician. Acupuncture treatment was effective for cancer pain in 15 of 23 patients (65.2%), and these patients showed a clear improvement immediately after treatment compared with before. The incidence of adverse events was 0%, suggesting that acupuncture is a very safe treatment.

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

Suspended

Date of protocol fixation

2013 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 01 Day

Last follow-up date

2013 Year 12 Month 27 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 12 Month 20 Day

Last modified on

2013 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014780


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name