UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017360
Receipt number R000020138
Scientific Title Assessment and analysis of the mechanisms for swelling and pain of the hand
Date of disclosure of the study information 2015/05/01
Last modified on 2020/05/04 09:24:21

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Basic information

Public title

Assessment and analysis of the mechanisms for swelling and pain of the hand

Acronym

Assessment and analysis of the mechanisms for swelling and pain of the hand

Scientific Title

Assessment and analysis of the mechanisms for swelling and pain of the hand

Scientific Title:Acronym

Assessment and analysis of the mechanisms for swelling and pain of the hand

Region

Japan


Condition

Condition

condition of swelling and pain of the hand

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the relevance of the pain and swelling of the hand

Basic objectives2

Others

Basic objectives -Others

I will evaluate the pain using questionnaire such as VAS scale, and the swelling using a 3D scanner.
I will enforce MEG and functional MRI to check the relevance of mechanism analysis of symptom improvement.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

VAS scale,hand volume, magnetoencephalogram, functional MRI
3,6 months after the test started

Key secondary outcomes

questionnaire about pain of hand
3,6 months after the test started


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

hand pain(+)/hand swelling(+)
hand incubator
once a day for one hour
for half year

Interventions/Control_2

hand pain(+)/hand swelling(-)
hand incubator
once a day for one hour
for half year

Interventions/Control_3

hand pain(-)/hand swelling(+)
hand incubator
once a day for one hour
for half year

Interventions/Control_4

hand pain(-)/hand swelling(-)

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

a patient who has the pain or swelling of the hand, understood this research content and obtained the written consent
a healthy volunteer who understood this research content and obtained the written consent

Key exclusion criteria

a people who couldn't agree this research
a people who couldn't answer the functional assessment

Target sample size

160


Research contact person

Name of lead principal investigator

1st name HIRATA
Middle name
Last name Hitoshi

Organization

Graduate School & School of Nagoya University

Division name

Department of Hand Surgery

Zip code

466-8550

Address

65 Turumai Showa-ku Nagoya Aichi

TEL

+81-52-744-2957

Email

chikusa@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name SHINKAI
Middle name
Last name Hiroki

Organization

Graduate School & School of Nagoya University

Division name

Department of Hand Surgery

Zip code

466-8550

Address

65 Turumai Showa-ku Nagoya Aichi

TEL

+81-52-744-2957

Homepage URL


Email

sihnnkai@yahoo.co.jp


Sponsor or person

Institute

Department of Hand Surgery, Nagoya University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology, MEXT

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Department of Hand Surgery, Graduate School & School of Nagoya University

Address

65 Turumai Showa-ku Nagoya Aichi

Tel

052-741-2111

Email

sihnnkai@yahoo.co.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

名古屋大学附属病院(愛知県)
Nagoya University Hospital(Aichi)


Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

24

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

Main results already published

Date of protocol fixation

2015 Year 04 Month 27 Day

Date of IRB

2015 Year 05 Month 25 Day

Anticipated trial start date

2015 Year 05 Month 25 Day

Last follow-up date

2020 Year 05 Month 24 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 05 Month 01 Day

Last modified on

2020 Year 05 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020138


Research Plan
Registered date File name
2016/05/01 ③別記様式第2号の4 研究計画書(臨床介入研究)最終.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2016/05/01 Book1.xlsx