UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028301