UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042080 |
|---|---|
| Receipt number | R000048001 |
| Scientific Title | Effects of an intervention to posterior shoulder tightness on the scapular fossa, humeral head position, and subacromial space in the overhead athlete. |
| Date of disclosure of the study information | 2020/10/11 |
| Last modified on | 2020/10/11 21:52:27 |
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Basic information
Public title
Does treating the posterior shoulder area stiffness in athletes affect the positional relationship of the shoulder joint?
Acronym
Posterior shoulder tightness intervention study
Scientific Title
Effects of an intervention to posterior shoulder tightness on the scapular fossa, humeral head position, and subacromial space in the overhead athlete.
Scientific Title:Acronym
Posterior shoulder tightness intervention study
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of manual inter-structural release (ISR) for posterior shoulder structures on the humeral head position.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
range of motion
Key secondary outcomes
humeral head position relative to the glenoid
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Inter-Structural Release
4 weeks
Interventions/Control_2
stretching
4 weeks
Interventions/Control_3
Control
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
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
healthy
Key exclusion criteria
had a history of surgery on the shoulder,
had any injuries, pain, or dysfunction in the shoulder, neck, spine or upper extremity at the time of the study
could not understand the subject
had problems with communication
could not undergo Magnetic Resonance Imaging, e.g. claustrophobia
were participating in overhead activities, competitive sports, or weight training.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | koki |
| Middle name | |
| Last name | hamada |
Organization
Sadamatsu Hospital
Division name
Rehabilitation
Zip code
8560831
Address
537, higashihonmachi, Omura city, Nagasaki
TEL
0957-54-1161
kouki.hamada617@gmail.com
Public contact
Name of contact person
| 1st name | koki |
| Middle name | |
| Last name | hamada |
Organization
Sadamatsu Hospital
Division name
Rehabilitation
Zip code
8560831
Address
537, higashihonmachi, Omura city, Nagasaki
TEL
0957541161
Homepage URL
kouki.hamada617@gmail.com
Sponsor or person
Institute
Sadamatsu Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Sadamatsu Hospital Ethics Committee
Address
537, higashihonmachi, Omura city, Nagasaki
Tel
0957541161
kouki.hamada617@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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 11 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f3.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi
Number of participants that the trial has enrolled
24
Results
The ISR group showed 17.2degree (p = .003) improvement in flexion, 10.1degree (p = .01) in HAd, 13.0degree (p = .005) in IR and 16.4degree (p = .004) in total arc (ER+IR).
Humeral head position did not change in any groups and showed no correlation with range of motion.
Results date posted
| 2020 | Year | 10 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
asymptomatic general subjects
Participant flow
We provided all participants with explanations and asked them to provide written consent regarding risks and disadvantages of study participation.
Adverse events
There were no adverse events.
Outcome measures
range of motion of flexion, horizontal adduction, internal rotation, external rotation and total arc
humeral head position relative to the glenoid
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 11 | Day |
Last modified on
| 2020 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048001
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
