UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009442 |
|---|---|
| Receipt number | R000011022 |
| Scientific Title | A randomized, double-blind, sham-controlled study of static electric field therapy by high voltage alternating current for active rheumatoid arthritis |
| Date of disclosure of the study information | 2012/11/30 |
| Last modified on | 2014/11/30 20:48:48 |
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Basic information
Public title
A randomized, double-blind, sham-controlled study of static electric field therapy by high voltage alternating current for active rheumatoid arthritis
Acronym
EF-HVAC-RA
Scientific Title
A randomized, double-blind, sham-controlled study of static electric field therapy by high voltage alternating current for active rheumatoid arthritis
Scientific Title:Acronym
EF-HVAC-RA
Region
| Japan |
Condition
Condition
a randomized, double-blinded, sham-controlled trial
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of static electric field therapy by high voltage alternating current (EF-HVAC) for rheumatoid arthritis (RA)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the improvement of the activity of subjects by 28-joints disease activity score based on CRP (DAS28-CRP)
Key secondary outcomes
VAS for pain, swollen joint score, tender joint score, modified health assessment questionnaire, and changes in laboratory measures of biomarkers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
EF-HVAC therapy group: Patients were exposed to EF-HVAC with a high voltage value for 20 min a day until 2 weeks, and then were treated 60 min a day to 12 week using a Legacis Plus System (COCOROKA Ltd., Tokyo, Japan). The voltage and other level of apparatus were not changed during the study.
Interventions/Control_2
Sham therapy group: Patients were exposed to sham-apparatus by the same protocol.
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Selected patients presented RA and fulfilled the ACR 1987 criteria for diagnosis of RA.
Key exclusion criteria
Patients were excluded from the study if they received biological therapies for RA, were diagnosed with another inflammatory disease or experienced uncontrolled or clinically significant systemic diseases other than RA.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kamigyo-ku,Kyoto
TEL
+81752515519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Gastroenterology and Hepatology
Zip code
Address
465 Kajii-cho, Kamigyo-ku,Kyoto
TEL
+81752515519
Homepage URL
ynaito@koto.kpu-m.ac.jp
Sponsor or person
Institute
Toshikazu Yoshikawa
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (B) to
T. Yoshikawa (no. 21390184)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
| 2012 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 30 | Day |
Last modified on
| 2014 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011022
