UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000049745
Receipt number R000056664
Scientific Title Comprehensive prospective observational study of effectiveness of acupuncture and manual therapy
Date of disclosure of the study information 2022/12/12
Last modified on 2022/12/11 19:54:54

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Basic information

Public title

Prospective observational study of effectiveness of acupuncture and manual therapy

Acronym

effectiveness of acupuncture and manual therapy

Scientific Title

Comprehensive prospective observational study of effectiveness of acupuncture and manual therapy

Scientific Title:Acronym

effectiveness of acupuncture and manual therapy

Region

Japan


Condition

Condition

Users of acupuncture and manual therapy

Classification by specialty

Medicine in general Surgery in general Obstetrics and Gynecology
Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Prospective observation and analysis of effectiveness of acupuncture and manual therapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

ADL

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

Users for acupuncture and manual therapy

Key exclusion criteria

none

Target sample size

10000


Research contact person

Name of lead principal investigator

1st name Asami
Middle name
Last name Uchida

Organization

Fureasu

Division name

F.C.L.

Zip code

141-0031

Address

Nishigotanda 2-27-3-3F, Shinagawa, Tokyo

TEL

03-6632-9215

Email

fcl@fureasu.jp


Public contact

Name of contact person

1st name Asami
Middle name
Last name Uchida

Organization

Fureasu

Division name

F.C.L.

Zip code

151-0061

Address

Hatsudai 2-5-8-2F, Shibuya, Tokyo

TEL

03-6632-9215

Homepage URL


Email

fcl@fureasu.jp


Sponsor or person

Institute

Fureasu F.C.L.

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

The University of Tokyo Hospital, Department of Pain and Palliative Medicine
AIST

Name of secondary funder(s)

none


IRB Contact (For public release)

Organization

Fureasu

Address

Nishigotanda 2-27-3-3F, Shinagawa, Tokyo

Tel

03-6632-9215

Email

fcl@fureasu.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



Other administrative information

Date of disclosure of the study information

2022 Year 12 Month 12 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

Preinitiation

Date of protocol fixation

2022 Year 10 Month 14 Day

Date of IRB

2022 Year 10 Month 14 Day

Anticipated trial start date

2022 Year 12 Month 11 Day

Last follow-up date

2032 Year 12 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2022 Year 12 Month 11 Day

Last modified on

2022 Year 12 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056664


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name