UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043253
Receipt number R000049349
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
Date of disclosure of the study information 2021/02/04
Last modified on 2021/02/04 23:14:44

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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 or person

Institute

Fukuoka Reha Orthopedic Clinic
Rehabilitation Department

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049349


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name