UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047440 |
|---|---|
| Receipt number | R000054030 |
| Scientific Title | Effects of combined Acute exercise and frequency-modulated transcutaneous electrical nerve stimulation on pain |
| Date of disclosure of the study information | 2022/04/10 |
| Last modified on | 2022/11/13 15:47:36 |
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Basic information
Public title
Effects of combined Acute exercise and frequency-modulated transcutaneous electrical nerve stimulation on pain
Acronym
Effects of combined comfort walking and electrical stimulation therapy on pain
Scientific Title
Effects of combined Acute exercise and frequency-modulated transcutaneous electrical nerve stimulation on pain
Scientific Title:Acronym
Effects of combined comfort walking and electrical stimulation therapy on pain
Region
| Japan |
Condition
Condition
adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of frequency-modulated transcutaneous electrical nerve stimulation,and to clarify the added value of the combination of comfort walking and frequency-modulated transcutaneous electrical nerve stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Current perception threshold
2.Current pain threshold (A-delta fiber)
3.Pressure pain threshold (PPT)
4.Temporal summation of pain (TSP)
Key secondary outcomes
1.International Physical Activity Questionnaire Japanese version short version, usual week (IPAQ)
2.State-trait anxiety inventory-Form JYZ Y-2(STAI Y-2)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
TENS group
Interventions/Control_2
Placebo TENS group
Interventions/Control_3
Acute Exercise and TENS group
Interventions/Control_4
Acute Exercise and Placebo TENS group
Interventions/Control_5
Control group
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
pain-free adults
Key exclusion criteria
persons who have acute or chronic pain
persons using analgesics
persons with mental illness
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Miki |
| Middle name | |
| Last name | Tokue |
Organization
Honjo-General Hospital
Division name
Department of Rehabilitation
Zip code
367-0031
Address
1780 Kitabori, Honjo City Saitama,Japan
TEL
0495-22-6111
2030204@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Tokue |
Organization
Honjo-General Hospital
Division name
Department of Rehabilitation
Zip code
367-0031
Address
1780 Kitabori, Honjo City Saitama,Japan
TEL
0495-22-6111
Homepage URL
2030204@takasaki-u.ac.jp
Sponsor or person
Institute
Honjo-General Hospital
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Honjo-General Hospital
Address
1780 Kitabori, Honjo City Saitama,Japan
Tel
0495-22-6111
2030204@takasaki-u.ac.jp
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
| 2022 | Year | 04 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 04 | Month | 08 | Day |
Last modified on
| 2022 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054030
