UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024596 |
|---|---|
| Receipt number | 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 11:40:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
t-nishi@konan-wu.ac.jp
Sponsor or person
Institute
Konan Woman University
Institute
Department
Personal name
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
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
Value
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 |
