UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000042080
Receipt No. 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 (Ver. 1)

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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
Email 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
Email kouki.hamada617@gmail.com

Sponsor
Institute Sadamatsu Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048001