UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047262 |
|---|---|
| Receipt number | R000053903 |
| Scientific Title | Establishment of an effective treatment method using extracorporeal shock wave for contracture shoulder |
| Date of disclosure of the study information | 2022/03/23 |
| Last modified on | 2024/07/31 09:27:18 |
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Basic information
Public title
Establishment of an effective treatment method using extracorporeal shock wave for contracture shoulder
Acronym
Study of exteracorporeal shock wave therapy for shoulder contracture
Scientific Title
Establishment of an effective treatment method using extracorporeal shock wave for contracture shoulder
Scientific Title:Acronym
Study of exteracorporeal shock wave therapy for shoulder contracture
Region
| Japan |
Condition
Condition
Frozen shoulder,rotator cuff tear, adhesive capsulitis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of different limb positions for extracorporeal shock wave irradiation on muscle flexibility
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
muscle frexibility of Teres minor muscle,Infraspinattus,Deltoid muscle.
Key secondary outcomes
3rd internal rotation range of motion before and after treatment
Visual analogue scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Extracorporeal shock wave therapy to the teres minor muscle in the 90 degrees flexed shoulder joint position
Interventions/Control_2
Extracorporeal shock wave therapy to the teres minor muscle in the 0 degrees of shoulder frexion
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosis of adhesive capsulitis
Diagnosis rotater cuff tear
Shoulder jouint fraxion angle of 90degrees or more
Key exclusion criteria
Shoulder joint fraxion angle less than 90 degrees
Surgical art
With trauma,dislocation or subluxation
With systemic inframmatory diseases
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shintarou |
| Middle name | |
| Last name | Kudo |
Organization
Morinomiya University of Medical Sciences
Division name
Inclusive medical science research institute
Zip code
559-8611
Address
Nanko-kita,1-26-16, Suminoe ward, Osaka
TEL
0666166911
kudo@morinomiya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shintarou |
| Middle name | |
| Last name | Kudo |
Organization
Morinomiya University of Medical Sciences
Division name
Inclusive medical science research institute
Zip code
559-8611
Address
Nanko-kita,1-26-16, Suminoe ward
TEL
0666166911
Homepage URL
kudo@morinomiya-u.ac.jp
Sponsor or person
Institute
Morinomiya university of medical sciences
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Board, Morinomiya University of Medical Sciences
Address
Nanko-kita,1-26-16, Suminoe ward
Tel
0666166911
kenkyu@morinomiya-u.ac.jp
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
芦屋整形外科スポーツクリニック
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 23 | Day |
Last modified on
| 2024 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053903
