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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043691
Receipt No. 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 2021/03/22

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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
Email 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
Email t.yamaguchi.ja@juntendo.ac.jp

Sponsor
Institute Juntendo university
Institute
Department

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
Email 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 Enrolling by invitation
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
2022 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
2021 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049797

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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