UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020149 |
|---|---|
| Receipt number | R000023268 |
| Scientific Title | An experimental study of low-intensity pulsed ultrasound (LIPUS) treatment for shoulder disorders. |
| Date of disclosure of the study information | 2015/12/17 |
| Last modified on | 2019/02/08 18:38:35 |
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Basic information
Public title
An experimental study of low-intensity pulsed ultrasound (LIPUS) treatment for shoulder disorders.
Acronym
An experimental study of low-intensity pulsed ultrasound (LIPUS) treatment for shoulder disorders.
Scientific Title
An experimental study of low-intensity pulsed ultrasound (LIPUS) treatment for shoulder disorders.
Scientific Title:Acronym
An experimental study of low-intensity pulsed ultrasound (LIPUS) treatment for shoulder disorders.
Region
| Japan |
Condition
Condition
Rotator cuff tear and recurrent shoulder dislocation
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of LIPUS treatment on soft tissue healing of shoulder disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRI or CT findings at 3, 6 and 12 months after LIPUS treatment.
Key secondary outcomes
range of motion
muscle strength
DASH
shoulder36
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
LIPUS administration to the shoulder joint
Duration: 3 months
Administration time: 20 minutes per day
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosed as the rotator cuff tear or recurrent shoulder dislocation
Key exclusion criteria
Patients who cannot keep the rest position of shoulder for 20 minutes.
Mental illness
Dementia
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Miyamoto |
Organization
Tokyo medical and dental university
Division name
Department of functional joint anatomy
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4020
miyamoto.orj@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Miyamoto |
Organization
Tokyo medical and dental university
Division name
Department of functional joint anatomy
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4020
Homepage URL
miyamoto.orj@tmd.ac.jp
Sponsor or person
Institute
Tokyo medical and dental university
Institute
Department
Personal name
Funding Source
Organization
Tokyo medical and dental 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
| 2015 | Year | 12 | Month | 17 | 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
| 2015 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 10 | Day |
Last modified on
| 2019 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023268
