UMIN-CTR Clinical Trial

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
Email	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
Email	s_saito@meiji-u.ac.jp

Sponsor
Institute	Meiji University of Integrative Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052793