UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022160 |
|---|---|
| Receipt number | R000025538 |
| Scientific Title | Effect of illusory kinesthesia by vibratory tendon stimulation on patients after surgery for distal radius fractures |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2021/12/15 09:32:08 |
* 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 illusory kinesthesia by vibratory tendon stimulation on patients after surgery for distal radius fractures
Acronym
Effect of illusory kinesthesia on patients after surgery
Scientific Title
Effect of illusory kinesthesia by vibratory tendon stimulation on patients after surgery for distal radius fractures
Scientific Title:Acronym
Effect of illusory kinesthesia on patients after surgery
Region
| Japan |
Condition
Condition
distal radius fractures
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the effects of inducing an illusion of motion by tendon vibration on sensory and emotional aspects of pain, the activities of daily living and range of motion in patients with fractures of the distal radius.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain at res
pain during movement
the Patient-Rated Wrist Evaluation
Key secondary outcomes
the Pain Catastrophizing Scale
the Hospital Anxiety and Depression Scale
range of motion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
illusory kinesthesia by tendon vibration
Interventions/Control_2
non illusory kinethesia
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
| 50 | years-old | < |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
distal radius fractures
Key exclusion criteria
Patients were excluded if they had (1) severe chronic uncontrolled pain at a site other than the surgical wrist before the surgery (n = 4), or (2) stroke or other central nervous system disorders (n = 2).
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Imai |
Organization
Osaka Kawasaki Rehabilitaion University
Division name
School of Rehabilitation
Zip code
597-0104
Address
158 Mizuma, Kaizuka City Osaka 597-0104, Japan
TEL
072-446-6700
ryo7891@gmail.com
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Imai |
Organization
Osaka Kawasaki Rehabilitaion University
Division name
School of Rehabilitation
Zip code
597-0104
Address
158 Mizuma, Kaizuka City Osaka 597-0104, Japan
TEL
072-446-6700
Homepage URL
ryo7891@gmail.com
Sponsor or person
Institute
Osaka Kawasaki Rehabilitaion University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Kawachi General Hosipital
Address
1-3 Yokomakura, HigashiOsaka City, Osaka Japan
Tel
072-965-0731
ryo7891@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
河内総合病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
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
Main results already published
Date of protocol fixation
| 2014 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 20 | 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 | 05 | Month | 01 | Day |
Last modified on
| 2021 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025538
