UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050250 |
|---|---|
| Receipt number | R000057224 |
| Scientific Title | A novel transcutaneous electrical nerve stimulation for the dysesthesias in patients with spinal cord injury -single case experimental design- |
| Date of disclosure of the study information | 2023/02/10 |
| Last modified on | 2024/06/26 07:41:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A novel transcutaneous electrical nerve stimulation for the dysesthesias in patients with spinal cord injury -single case experimental design-
Acronym
A novel transcutaneous electrical nerve stimulation for the dysesthesias in patients with spinal cord injury -single case experimental design-
Scientific Title
A novel transcutaneous electrical nerve stimulation for the dysesthesias in patients with spinal cord injury -single case experimental design-
Scientific Title:Acronym
A novel transcutaneous electrical nerve stimulation for the dysesthesias in patients with spinal cord injury -single case experimental design-
Region
| Japan |
Condition
Condition
spinal cord injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To the effect of our novel proposed TENS on dysesthesias by spinal cord injury.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NRS of the dysesthesias
Key secondary outcomes
Short-Form McGill Pain Questionnaire version-2
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants 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
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
Sham TENS
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
| 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
6
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Nishi |
Organization
Nagasaki university
Division name
Biomedical Sciences (Health Sciences)
Zip code
852-8520
Address
1-7-1,sakamoto,nagasaki
TEL
+81-95-819-7909
y.nishi.pt@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nishi |
Organization
Nagasaki university
Division name
Biomedical Sciences (Health Sciences)
Zip code
852-8520
Address
1-7-1,sakamoto,nagasaki
TEL
+81-95-819-7909
Homepage URL
y.nishi.pt@gmail.com
Sponsor or person
Institute
Nagasaki university
Institute
Department
Personal name
Funding Source
Organization
KAKENHI, JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nishiyamato Rehabilitation Hospital
Address
3-2-2, kitakatsuragi-gun, nara
Tel
+81-745-71-6688
y.nishi.pt@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
0031
Org. issuing International ID_1
Nishiyamato Rehabilitation Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | 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
6
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 | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 04 | 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
| 2023 | Year | 02 | Month | 06 | Day |
Last modified on
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057224
