UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000024591
Receipt number	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 15:01:11

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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

Subacromial pain

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

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

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 or person

Institute

Konan Woman University

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
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