UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043691 |
|---|---|
| Receipt number | R000049797 |
| Scientific Title | The combined effects of transcutaneous electrical nerve stimulation combined with home exercise on knee pain, daily activities, and mental activities in older adults |
| Date of disclosure of the study information | 2021/03/22 |
| Last modified on | 2024/03/24 09:04:31 |
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Basic information
Public title
A study of transcutaneous electrical nerve stimulation combined with home exercise on knee pain in older adults
Acronym
A study of transcutaneous electrical nerve stimulation combined with home exercise
Scientific Title
The combined effects of transcutaneous electrical nerve stimulation combined with home exercise on knee pain, daily activities, and mental activities in older adults
Scientific Title:Acronym
The combined effects of transcutaneous electrical nerve stimulation combined with home exercise
Region
| Japan |
Condition
Condition
Older persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study is to investigate the combined effects of transcutaneous electrical nerve stimulation combined with home exercise on knee pain, daily activities, and mental activities in older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Pain visual analogue scale (VAS) at before, during, immediately after, and 4 weeks after the intervention
Key secondary outcomes
10 meter walking test, Time up and go(TUG) test, Knee extension strength, Pain Disability Assessment Scale(PDAS), Activity meter, Hospital Anxiety and Depression Scale(HADS), Pain Catastrophizing Scale(PCS), SF-36
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
TENS (2 hours per a day) and home exercise (20 minutes per a day) for a total of 20 days.
Interventions/Control_2
Sham TENS (no stimulation) and home exercise (20 minutes per a day) for a total of 20 days.
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
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
knee pain during walking (VAS score from 1 to 8)
Key exclusion criteria
1) knee deformity (Kellgren and Lawrence classification grade over 2)
2) severe sensory impairment
3) skin disease
4) any difficulty to exercise by diseases
5) severe cognitive impairment (Mini-Mental State Examination: MMSE>24)
6) implanted electronic pacing or defibrillation devices
7) episodes of epileptic seizures
8) episodes of psychiatric or neurological disorders
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Tomofumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Juntendo university
Division name
Faculty of Health Science, Department of Physical Therapy
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3812-1780
t.yamaguchi.ja@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tomofumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Juntendo university
Division name
Faculty of Health Science, Department of Physical Therapy
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan
TEL
03-3812-1780
Homepage URL
t.yamaguchi.ja@juntendo.ac.jp
Sponsor or person
Institute
Juntendo university
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Physio day service Miyabinosato
Miyabinosato rehabilitation center
Yatsu Kyotaku service center
Rehabili a eru
Nursing home Tochinoki
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Health Science, Juntendo University
Address
2-1-1 Hongo, Bunkyo-ku
Tel
03-3812-1780
t.yamaguchi.ja@juntendo.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
フィジオ・デイサービス雅の里（兵庫県）
雅の里リハビリテーションセンター（兵庫県）
谷津居宅サービスセンター（千葉県）
リハビリあ・える（奈良県）
介護老人保健施設とちのき（京都府）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 22 | 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
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | 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 | 03 | Month | 22 | Day |
Last modified on
| 2024 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049797
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| Registered date | File name |
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| Registered date | File name |
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