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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024596
Receipt No. R000028306
Scientific Title Effect of icing of non-treated sites in patients with total knee arthroplasty: A randomized cross-over study
Date of disclosure of the study information 2016/10/28
Last modified on 2020/03/18

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Basic information
Public title Effect of icing of non-treated sites in patients with total knee arthroplasty: A randomized cross-over study
Acronym Effect of icing of non-treated sites in patients with total knee arthroplasty
Scientific Title Effect of icing of non-treated sites in patients with total knee arthroplasty: A randomized cross-over study
Scientific Title:Acronym Effect of icing of non-treated sites in patients with total knee arthroplasty
Region
Japan

Condition
Condition Total knee arthroplasty:
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is that a pleasant sensation evoked by icing the treated knee or a site distant from the treated site (the hand) influenced the acute effect on pain intensity during maximal knee flexion in patients who have undergone total knee arthroplasty:.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Knee pain during maximal passive knee flexion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Icing of treated sites
Interventions/Control_2 Icing of non-treated sites
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
40 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria The inclusion criteria were patients who underwent primary TKA, over 40 years of age, and exhibiting ambulation before surgery.
Key exclusion criteria Exclusion criteria were revision TKA, nonambulatory before surgery, presence of severe inflammation, and evidence of deep vein thrombosis after surgery.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiko Nishigami
Organization Konan Woman University
Division name Department of Nursing and Physical Therapy
Zip code
Address 6-2-23, Morikita-machi, Higashinada-ku, Kobe, 658-0001,
TEL 0784133648
Email t-nishi@konan-wu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiko Nishigami
Organization Konan Woman University
Division name Department of Nursing and Physical Therapy
Zip code
Address 6-2-23, Morikita-machi, Higashinada-ku, Kobe, 658-0001,
TEL 0784133648
Homepage URL
Email t-nishi@konan-wu.ac.jp

Sponsor
Institute Konan Woman University
Institute
Department

Funding Source
Organization Konan Woman University
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 10 Month 28 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 10 Month 28 Day
Date of IRB
2016 Year 10 Month 10 Day
Anticipated trial start date
2016 Year 10 Month 28 Day
Last follow-up date
2018 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
2016 Year 10 Month 27 Day
Last modified on
2020 Year 03 Month 18 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028306

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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