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
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
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
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
