UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049305 |
|---|---|
| Receipt number | R000056152 |
| Scientific Title | Long-term effects of exercise while wearing TENS for knee pain patients |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2022/10/25 11:33:36 |
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Basic information
Public title
Long-term effects of exercise while wearing Electrical Nerve Stimulation (TENS) for knee pain patients
Acronym
Long-term effects of exercise while wearing TENS
Scientific Title
Long-term effects of exercise while wearing TENS for knee pain patients
Scientific Title:Acronym
Long-term effects of exercise while wearing TENS
Region
| Japan |
Condition
Condition
Knee osteoarthritis(OA)
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the long-term therapeutic promotion effects of transcutaneous electrical stimulation as an adjunct to exercise therapy in middle-aged and older adults with Knee osteoarthritis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time points for assessment:
Pre-intervention, 1-month follow-ups, 3-month follow-ups, 6-month follow-ups
Outcomes:
- Knee pain
Numerical Rating Scale(NRS)
- Disability
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
Key secondary outcomes
Time points for assessment:
Pre-intervention, 6-month follow-ups
Outcomes:
- Physical activity and sedentary behavior
Active Style Pro, OMRON HEALTHCARE Co., Ltd.
- Quantitative Sensory Testing (QST)
*Additional measurements at 3-month
- Body composition and physical function
Body Mass Index(BMI), 10-meter walk test, Timed up&Go test, 30s chair stand test, stand up test, 2-step test, locomo25, 12-steps stair climb test, Six minutes walk test
Pain Self-efficacy Questionnaire, Pain Catastrophizing scale, Tampa Scale for Kinesiophobia, Hospital Anxiety and Depression scale, Health-related quality of life(EQ-5D), Locomo-25, Patient-perceived satisfactory improvement(6-month follow-ups), and so on.
- Exercise adherence (frequency of performing each exercise by exercise-log)
- Medication behavior
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of TENS during walking exercise with brief home-based exercise program and education for 6 months
Interventions/Control_2
Just brief home-based exercise program and education for 6 months
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Knee pain for more than 3 months
2. Diagnosis of Knee osteoarthritis(OA)
3. Aged more than 40 years
Key exclusion criteria
1. patients who are scheduled to have surgery during the period.
2. patients who have been exercising for more than 30 minutes at least twice a week for more than one year.
3. patients with concomitant diseases other than OA in the affected area.
4. patients with a history of surgery in the affected area.
5. Patients with pain that limits motion in areas other than the knee.
6. systemic arthritis.
7. Patients with contraindications to electrical stimulation (pacemakers, SCS, insulin pumps, etc.)
8. significant psychiatric disorders (e.g., dementia) that may interfere with participation.
9. Patients deemed by the principal investigator to be ineligible for participation in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hironori |
| Middle name | |
| Last name | Saisu |
Organization
Aichi Medical University
Division name
Institute of Physical Fitness, Sports Medicine and Rehabilitation
Zip code
480-1195
Address
1-1 yazako karimata, Nagakute, Aichi
TEL
0561-62-5004
saisu.hironori.748@mail.aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Hironori |
| Middle name | |
| Last name | Saisu |
Organization
Aichi Medical University
Division name
Institute of Physical Fitness, Sports Medicine and Rehabilitation
Zip code
480-1195
Address
1-1 yazako karimata, Nagakute, Aichi
TEL
0561-62-5004
Homepage URL
saisu.hironori.748@mail.aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
OMRON HEALTHCARE Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee , Aichi Medical University School of Medicine
Address
1-1 yazako karimata, Nagakute, Aichi
Tel
0561-62-3311
amu_ethics@aichi-med-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
愛知医科大学 運動療育センター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 11 | Day |
Last follow-up date
| 2024 | 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 | 10 | Month | 25 | Day |
Last modified on
| 2022 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056152
