UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015574
Receipt number R000018096
Scientific Title Efficacy of acupuncture therapy on oversensitiveness to cold in adult females -a multicenter prospective randomized controlled trial
Date of disclosure of the study information 2014/11/05
Last modified on 2015/11/13 16:34:23

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Basic information

Public title

Efficacy of acupuncture therapy on oversensitiveness to cold in adult females -a multicenter prospective randomized controlled trial

Acronym

Efficacy of acupuncture therapy on oversensitiveness to cold in females - randomized controlled trial

Scientific Title

Efficacy of acupuncture therapy on oversensitiveness to cold in adult females -a multicenter prospective randomized controlled trial

Scientific Title:Acronym

Efficacy of acupuncture therapy on oversensitiveness to cold in females - randomized controlled trial

Region

Japan


Condition

Condition

oversensitiveness to cold

Classification by specialty

Medicine in general Cardiology Psychosomatic Internal Medicine
Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Verification of the efficacy of acupuncture therapy on oversensitiveness to cold in adult females by a multicenter prospective randomized controlled trial

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Variation of degree of hie on average visual analogue scale between before one week start of intervention and the second week start of intervention, after finish of intervention

Key secondary outcomes

Changes in eight heading score and two component summary of SF-36v2 Standard Edition before and after the intervention


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Needle retention to SP6 and electro-acupuncture therapy to BL32 at a frequency of 1Hz for 20min. for 4 sessions, with 1 session each other

Interventions/Control_2

No session(waiting list control)

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

18 years-old <=

Age-upper limit

39 years-old >=

Gender

Female

Key inclusion criteria

Adult females with oversensitiveness to cold and more than four point of total score in the" hiesho sensation scale"

Key exclusion criteria

1)pregnant or nursing
2)diabetes mellitus complicated by peripheral neuropathy
3)arteriosclerosis obliterans
4)Buerger's disease
5)connective tissue disease
6)hypothyroidism
7)hyperthyroidism
8)Patients medicated with following drugs every day: Chinese herbal medicine, alpha blocker, beta blocker, alpha and blocker, calcium antagonist and prostaglandinE1

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shunji Sakaguchi

Organization

Kansai University of Health Sciences

Division name

Department of Acupuncture-Moxibustion and Sports Trainer Sciences, Faculty of Health Sciences

Zip code


Address

2-11-1 Wakaba, Kumatori, Sennan, Osaka, Japan

TEL

072-453-8409

Email

sakaguti@kansai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shunji Sakaguchi

Organization

Kansai University of Health Sciences

Division name

Department of Acupuncture-Moxibustion and Sports Trainer Sciences, Faculty of Health Sciences

Zip code


Address

2-11-1 Wakaba, Kumatori, Sennan, Osaka, Japan

TEL

072-453-8409

Homepage URL


Email

sakaguti@kansai.ac.jp


Sponsor or person

Institute

Kansai University of Health Sciences

Institute

Department

Personal name



Funding Source

Organization

Kansai University of Health Sciences

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN


Other related organizations

Co-sponsor

Tsukuba University of Technology, Osaka Medical College, Takarazuka University of Medical and Health Care, Morinomiya University of Health Sciences, Riseisha College of Medicine and Sport

Name of secondary funder(s)

Tsukuba University of Technology


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

関西医療大学(大阪府)、筑波技術大学(茨城県)、宝塚医療大学(兵庫県)、森ノ宮医療大学(大阪府)、履生社医療スポーツ専門学校(大阪府) Kansai University of Health Sciences(Osaka), Tsukuba University of Technology(Ibaragi), Takarazuka University of Medical and Health Care(Hyogo), Morinomiya University of Health Sciences(Osaka), Riseisha College of Medicine and Sport(Osaka)


Other administrative information

Date of disclosure of the study information

2014 Year 11 Month 05 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

Completed

Date of protocol fixation

2014 Year 09 Month 30 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 01 Day

Last follow-up date

2014 Year 12 Month 27 Day

Date of closure to data entry

2015 Year 02 Month 20 Day

Date trial data considered complete

2015 Year 03 Month 20 Day

Date analysis concluded

2015 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2014 Year 10 Month 31 Day

Last modified on

2015 Year 11 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018096


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name