UMIN-CTR Clinical Trial

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
Email	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
Email	ryo7891@gmail.com

Sponsor
Institute	Osaka Kawasaki Rehabilitaion University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025538