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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024591
Receipt No. R000028301
Scientific Title What kind of patients with subacromial pain are likely to benefit from a specific exercises strategy: A Randomized Controlled Trial
Date of disclosure of the study information 2016/10/30
Last modified on 2020/10/29

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Basic information
Public title What kind of patients with subacromial pain are likely to benefit from a specific exercises strategy: A Randomized Controlled Trial
Acronym What kind of patients with subacromial pain are likely to benefit from a specific exercises strategy
Scientific Title What kind of patients with subacromial pain are likely to benefit from a specific exercises strategy: A Randomized Controlled Trial
Scientific Title:Acronym What kind of patients with subacromial pain are likely to benefit from a specific exercises strategy
Region
Japan

Condition
Condition Subacromial pain
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of our study was to examine the clinical tests for rotator cuff pathology and subacromial impingement, measured at baseline, that could predict shoulder disability and pain intensity in patients with subacromial pain after a 4 weeks training period using specific exercises, including eccentric training and scapula stabilizers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes American Shoulder and Elbow Surgeons shoulder score
Key secondary outcomes Pain intensity
Neer impingement sign
Hawkins impingement sign
Painful arc sign
Impingement syndrome;
Jobe test
Whipple test

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Eccentric excersice
Exercise was repeated 15 times in three sets once a day, three times a week for 4 weeks
Interventions/Control_2 Concentric excersice
Exercise was repeated 15 times in three sets once a day, three times a week for 4 weeks
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria All patients do not have schedule for surgery. No physiotherapy could have been received prior to the study. Participants were included according to the following criteria: (1) age between 18 and 80 years, (2) an ability to complete the questionnaires, and (3) shoulder pain induced by resisted muscle testing in shoulder abduction or external rotation.
Key exclusion criteria (1) a history of shoulder surgery, (2) a history of shoulder fractures, dislocation, cervical radiculopathy, degenerative joint disease of the shoulder, severe frozen should, or the demonstration of rotator cuff calcific tendinopathy. (3) cervical repeated movement testing affected shoulder pain.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiko Nishigami
Organization Konan Woman University
Division name Department of Nursing and Physical Therapy
Zip code
Address 6-2-23, Morikita-machi, Higashinada-ku, Kobe, 658-0001,
TEL 0784133648
Email t-nishi@konan-wu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiko Nishigami
Organization Konan Woman University
Division name Department of Nursing and Physical Therapy
Zip code
Address 6-2-23, Morikita-machi, Higashinada-ku, Kobe, 658-0001,
TEL 0784133648
Homepage URL
Email t-nishi@konan-wu.ac.jp

Sponsor
Institute Konan Woman University
Institute
Department

Funding Source
Organization Konan Woman 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
Email

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
2016 Year 10 Month 30 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
2016 Year 10 Month 30 Day
Date of IRB
2016 Year 10 Month 31 Day
Anticipated trial start date
2016 Year 11 Month 07 Day
Last follow-up date
2020 Year 10 Month 01 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 10 Month 27 Day
Last modified on
2020 Year 10 Month 29 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028301

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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