UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020540
Receipt number R000023648
Scientific Title Randomized controlled trial about the lymph drainage intervention in the physiotherapy after the total knee arthroplasty
Date of disclosure of the study information 2016/01/13
Last modified on 2019/01/14 21:43:26

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Basic information

Public title

Randomized controlled trial about the lymph drainage intervention in the physiotherapy after the total knee arthroplasty

Acronym

RCT examination about the lymph drainage intervention after the total knee replacement

Scientific Title

Randomized controlled trial about the lymph drainage intervention in the physiotherapy after the total knee arthroplasty

Scientific Title:Acronym

RCT examination about the lymph drainage intervention after the total knee replacement

Region

Japan


Condition

Condition

knee osteoarthritis

Classification by specialty

Surgery in general Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

For a patient of acute phase after the total knee arthroplasty, I inspect the effectiveness of the inflammatory symptom (a feeling of sharp pain, swelling, heat, functional disorder) reduction by the lymph drainage intervention.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

pain of about the tenth day after surgery

Key secondary outcomes

circumference,muscle strength,maximum gait velocity


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

The intervention group does it in addition to the normal physiotherapy of approximately 40 minutes with a group giving the lymph drainage of 20 minutes. I do it after an operation after an operation until the tenth day from the third day during the period and carry out the frequency five times once a day within a period.

Interventions/Control_2

The control group assumes it a group giving only the normal physiotherapy of approximately 40 minutes.

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

45 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

(1)The age at registration is a patient younger than 85 years 45 years old or older
(2)The patient who agreed to osteoarthrosis being diagnosed, and doing total knee arthroplasty
(3)The patient who has not been for the joint by total knee arthroplasty so far.
(4)The patient who plans unilateral total knee arthroplasty.
(5)The patient who was able to perform intervention of the physical therapy before operation.
(6)The patient that an answer to questionary survey is possible.
(7)The patient that an agreement is provided in a document about the participation of this study.

Key exclusion criteria

(1)It is a patient with the past with deep vein thrombosis or heart failure.
(2)Under 45 years old, patient 85 years or older
(3)The patient who receives total knee arthroplasty at the both sides same time.
(4)Severe cognitive functional decline and patient with a mental disorder.
(5)In addition, the patient whom it was judged the judgment of the doctor to be inappropriate as an object.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tatsu Fujiura

Organization

yokohama city university medical center

Division name

rehabilitation division

Zip code


Address

4-57, Urafunecho, Minami-ku, Yokohama-shi, Kanagawa

TEL

045-261-5656

Email

tatsufujiura@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Tatsu Fujiura

Organization

yokohama city university medical center

Division name

rehabilitation division

Zip code


Address

4-57, Urafunecho, Minami-ku, Yokohama-shi, Kanagawa

TEL

045-261-5656

Homepage URL


Email

tatsufujiura@gmail.com


Sponsor or person

Institute

yokohama city university medical center

Institute

Department

Personal name



Funding Source

Organization

non

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


Address


Tel


Email



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

2016 Year 01 Month 13 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

Completed

Date of protocol fixation

2016 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 07 Day

Last follow-up date

2018 Year 06 Month 30 Day

Date of closure to data entry

2018 Year 07 Month 31 Day

Date trial data considered complete

2018 Year 07 Month 31 Day

Date analysis concluded

2018 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 01 Month 13 Day

Last modified on

2019 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023648


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name