UMIN-CTR Clinical Trial

Basic information
Public title	Preliminary validation of whole-body vibration training for pain and muscle strength in middle-aged and older adults with early knee osteoarthritis. -A Non-Randomized Controlled Trial
Acronym	Preliminary validation of whole-body vibration training for pain and muscle strength in middle-aged and older adults with early knee osteoarthritis. -A Non-Randomized Controlled Trial
Scientific Title	Preliminary validation of whole-body vibration training for pain and muscle strength in middle-aged and older adults with early knee osteoarthritis. -A Non-Randomized Controlled Trial
Scientific Title:Acronym	Preliminary validation of whole-body vibration training for pain and muscle strength in middle-aged and older adults with early knee osteoarthritis. -A Non-Randomized Controlled Trial
Region	Japan

Condition
Condition	early stage knee osteoarthritis
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the effects and feasibility of whole-body vibration training on pain and muscle strength in middle-aged and elderly people with early-stage knee osteoarthritis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 8 weeks post intervention
Key secondary outcomes	Weight ratio of isometric knee extensor strength and 30-second chair rise test at 8 weeks after intervention

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Regular physical therapy consisting of manual therapy, range of motion exercises, muscle strengthening exercises, and aerobic exercises will be performed at least twice a week for 8 weeks. In addition, whole body vibration training will be performed, with a protocol of 6 to 8 sets of 25 to 30 Hz for 30 to 45 seconds, at least twice a week.
Interventions/Control_2	Regular physical therapy consisting of manual therapy, range of motion exercises, muscle strengthening exercises, aerobic exercises, etc., at least twice a week for 8 weeks.
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	35 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Those who have experienced at least two episodes of pain lasting more than 10 days in the last year. Patients with kellgren-lawrence grade 0-2 on x-ray. Patients who have visited our clinic and are eligible for rehabilitation.
Key exclusion criteria	Those with a history of knee trauma or surgery. Patients who have difficulty walking on their own. Patients with obvious bone marrow lesion and symptoms Patients with extreme frailty or sarcopenia. Those with complications of diseases such as diabetes, cardiovascular, respiratory, malignant tumors, and systemic arthritis. Patients with psychiatric disorders or neurological findings.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name takumi Middle name Last name manabe
Organization	Fukuoka Reha Orthopedic Clinic
Division name	Rehabilitation Department
Zip code	819-8551
Address	7-770 Nokata, Nishi-ku, Fukuoka City, Fukuoka Prefecture
TEL	092-812-1880
Email	tk.m64.b.kyt.8@gmail.com

Public contact
Name of contact person	1st name takumi Middle name Last name manabe
Organization	Fukuoka Reha Orthopedic Clinic
Division name	Rehabilitation Department
Zip code	819-8551
Address	7-770 Nokata, Nishi-ku, Fukuoka City, Fukuoka Prefecture
TEL	092-812-1880
Homepage URL
Email	tk.m64.b.kyt.8@gmail.com

Sponsor
Institute	Fukuoka Reha Orthopedic Clinic Rehabilitation Department
Institute
Department

Funding Source
Organization	Fukuoka Reha Orthopedic Clinic Rehabilitation Department
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukuoka Reha Orthopedic Clinic
Address	7-770 Nokata, Nishi-ku, Fukuoka City, Fukuoka Prefecture
Tel	092-812-1880
Email	tk.m64.b.kyt.8@gmail.com

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

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 04 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 06 Month 01 Day
Date of IRB	2020 Year 07 Month 18 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2021 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 02 Month 04 Day
Last modified on	2021 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049349