UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046322 |
|---|---|
| Receipt number | R000052793 |
| Scientific Title | Effects of Low frequency therapy in chronic knee pain |
| Date of disclosure of the study information | 2021/12/10 |
| Last modified on | 2021/12/08 13:38:10 |
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Basic information
Public title
Effects of Low frequency therapy in chronic knee pain
Acronym
Effects of Low frequency therapy in chronic knee pain
Scientific Title
Effects of Low frequency therapy in chronic knee pain
Scientific Title:Acronym
Effects of Low frequency therapy in chronic knee pain
Region
| Japan |
Condition
Condition
chronic knee pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of low frequency electric therapy in
chronic knee pain
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS
Key secondary outcomes
SF-MPQ-2,Borg scale,WOMACS,Stepping the stairs,CS-30,6MWT,TUG
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Low frequency electric therapy at 1Hz
Interventions/Control_2
Low frequency electric therapy at 20Hz
Interventions/Control_3
Low frequency electric therapy at 100Hz
Interventions/Control_4
no treatment
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
More than 6M in pain
Diagnosis of osteoarthritis of the knee
Knee pain walking and stairs going up and down more than six days for the latest one-week
Key exclusion criteria
Corresponding to the contraindicated condition of the low frequency treatment device
Walker using the stick
Bone fracture, sprain, pulled muscle
Total Knee Arthroplasty
High blood pressure
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Itoh |
Organization
Meiji University of Integrative Medicine
Division name
Acupuncture and Moxibiustion
Zip code
629-0392
Address
Hiyoshi-cho, Nantan, Kyoto
TEL
0771721181
k_itoh@meiji-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Saito |
Organization
Meiji University of Integrative Medicine
Division name
Acupuncture and Moxibiustion
Zip code
629-0392
Address
Hiyoshi-cho, Nantan, Kyoto
TEL
0771721181
Homepage URL
s_saito@meiji-u.ac.jp
Sponsor or person
Institute
Meiji University of Integrative Medicine
Institute
Department
Personal name
Funding Source
Organization
OMRON HEALTHCARE Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji University of Integrative Medicine
Address
Research Support Division
Tel
0771721181
sec_scie@meiji-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
明治国際医療大学
オムロンヘルスケア
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | 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 | 12 | Month | 08 | Day |
Last modified on
| 2021 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052793
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
