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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002588
Receipt No. 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

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

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
URL(English) https://upload.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


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