UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002588
Receipt number R000003164
Scientific Title Clinical trial of acupuncture for diabetic peripheral neuropathy
Date of disclosure of the study information 2009/10/10
Last modified on 2011/10/07 17:44:17

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Basic information

Public title

Clinical trial of acupuncture for diabetic peripheral neuropathy

Acronym

Clinical trial of acupuncture for diabetic peripheral neuropathy

Scientific Title

Clinical trial of acupuncture for diabetic peripheral neuropathy

Scientific Title:Acronym

Clinical trial of acupuncture for diabetic peripheral neuropathy

Region

Japan


Condition

Condition

Diabetic Peripheral Neuropathy

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of electroacupuncture on peripheral diabetic neuropathy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

Severity of numbness/pain in the extremities which was evaluated with a visual analog scale (VAS).

Key secondary outcomes

Severity of the symptom with a faces scale, McGill-Melzack Pain Questionnaire (MPQ), SF-36 (QOL), Profile of mood status (POMS), Nerve conduction velocity, sensory threshold (Semmes-Weinstein Monofilament test), Autonomic nerve function, Vibratory sensation threshold.


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

Maneuver

Interventions/Control_1

Electroacucpuncture (3/20Hz) will be performed on upper and/or lower extremities once a week for seven consecutive weeks.

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

1) Patients who are diagnosed as Type1 or Type2 diabetes and have numbness/pain in the extremities.
2) Obtaining written informed consent.
3) No severe disfunction in the: liver, kidney, respiration and hematopoietic system.

Key exclusion criteria

1) Patient who have any one of the following conditions;
# neuropathic disorder such as sciatica
# symptoms considered to be related with peripheral entrapment neuropathy such as tarsal tunnel syndrome.
# Sensory disturbance related with cerebrovascular disease.
# Disturbance in the peripheral circulation such as Raynaud's disease or arteriosclerosis obliterans (ASO).
2) Severely uncontrolled blood glucocse (HbA1c=>10%).
3) Currntly pregnant or possibility of pregnancy.
4) Psychiatric disordes or any kind of cognitive dysfunctions that make understanding of the participation to the trial difficult.
5) Other conditions that are not considered eligible by the physician.

Target sample size

20


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

Department of Complementary and Alternative Medicine

Zip code


Address

2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

06-6879-3498

Email



Public contact

Name of contact person

1st name
Middle name
Last name Toshinori Ito

Organization

Osaka University Graduate School of Medicine

Division name

Department of Complementary and Alternative Medicine

Zip code


Address

2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

06-6879-3498

Homepage URL


Email

juki@CAM.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Complementary and Alternative Medicine, Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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



Other administrative information

Date of disclosure of the study information

2009 Year 10 Month 10 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

Enrolling by invitation

Date of protocol fixation

2009 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 10 Month 01 Day

Last follow-up date

2011 Year 06 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 10 Month 06 Day

Last modified on

2011 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003164


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name