UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045332 |
|---|---|
| Receipt number | R000051769 |
| Scientific Title | The effects of the dysesthesia by a novel transcutaneous electrical nerve stimulation |
| Date of disclosure of the study information | 2021/09/02 |
| Last modified on | 2023/10/04 15:19:19 |
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Basic information
Public title
The effects of the dysesthesia by a novel transcutaneous electrical nerve stimulation
Acronym
the dysesthesia for a novel TENS
Scientific Title
The effects of the dysesthesia by a novel transcutaneous electrical nerve stimulation
Scientific Title:Acronym
the dysesthesia for a novel TENS
Region
| Japan |
Condition
Condition
diseases by the spinal cord dysfunctions
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To the effect of our novel proposed TENS on dysesthesias.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SF-MPQ2
Key secondary outcomes
ISNCSCI, SCIM, NPSI, SSEP, QST
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
a novel TENS, the stimulus intensity and the frequency of TENS are set to match the intensity and the somatosensory profile of the dysesthesias
Interventions/Control_2
control
Interventions/Control_3
high frequency TENS
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) dysesthesia duration of >3 months; (2) a score of >=3 on an 11-point numeric rating scale (NRS, 0 10) for dysesthesia intensity; (3) the ASIA Impairment Scale category C or D.
Key exclusion criteria
(1) history of peripheral arterial disease, diabetes, skin disorder, peripheral neuropathy, metabolic disorder, hyperventilation syndrome, amyotrophic lateral sclerosis, Parkinson's disease, autonomic neuropathy, or restless legs syndrome that may cause dysesthesia; (2) <24 on the Mini-Mental State Examination.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Nishi |
Organization
Kio University
Division name
Graduate School of Health Science
Zip code
635-0832
Address
Koryo-cho, Kitakatsuragi-gun, Nara
TEL
+81-74-554-1601
y.nishi.pt@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nishi |
Organization
Kio University
Division name
Graduate School of Health Science
Zip code
635-0832
Address
Koryo-cho, Kitakatsuragi-gun, Nara
TEL
+81-74-554-1601
Homepage URL
y.nishi.pt@gmail.com
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Self Funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
Koryo-cho, Kitakatsuragi-gun, Nara
Tel
+81-74-554-1601
y.nishi.pt@gmail.com
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
Nishiyamato Rehabilitation Hospital
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 02 | 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
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 01 | Day |
Last modified on
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051769
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| Registered date | File name |
| Research case data | |
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