UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028306