UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045454
Receipt number R000051897
Scientific Title Comparison of functional outcome between patients with physiotherapy or home-based programs after rotator cuff repair: A meta-analysis
Date of disclosure of the study information 2021/09/11
Last modified on 2022/09/11 23:37:25

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Basic information

Public title

Comparison of functional outcome between patients with physiotherapy or home-based programs after rotator cuff repair: A meta-analysis

Acronym

Comparison of functional outcome between patients with physiotherapy or home-based programs after rotator cuff repair: A meta-analysis

Scientific Title

Comparison of functional outcome between patients with physiotherapy or home-based programs after rotator cuff repair: A meta-analysis

Scientific Title:Acronym

Comparison of functional outcome between patients with physiotherapy or home-based programs after rotator cuff repair: A meta-analysis

Region

Japan


Condition

Condition

Rotator cuff tear

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to assess the functional outcomes between physiotherapy and home-based programs after rotator cuff repair.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

・Shoulder function score(Constant-Murley score, American Shoulder and Elbow Surgeons score, University of California Los Angeles shoulder score)
・Pain score

Key secondary outcomes

・Patient satisfaction rate
・Range of motion (forward elevation, abduction, external rotation, internal rotation)
・Strength (forward elevation, abduction, external rotation, internal rotation)


Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with rotator cuff repair

Key exclusion criteria

None

Target sample size



Research contact person

Name of lead principal investigator

1st name Masaki
Middle name
Last name Karasuyama

Organization

Minamikawa Orthopedic Hospital

Division name

Department of Rehabilitation

Zip code

819-0002

Address

4-14-17 Meinohama, Fukuoka

TEL

092-891-1234

Email

arukanjero@yahoo.co.jp


Public contact

Name of contact person

1st name Masaki
Middle name
Last name Karasuyama

Organization

Minamikawa Orthopedic Hospital

Division name

Department of Rehabilitation

Zip code

819-0002

Address

4-14-17 Meinohama, Fukuoka

TEL

092-891-1234

Homepage URL


Email

arukanjero@yahoo.co.jp


Sponsor or person

Institute

Minamikawa Orthopedic Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

None

Address

None

Tel

None

Email

None


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

2021 Year 09 Month 11 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

No longer recruiting

Date of protocol fixation

2021 Year 09 Month 11 Day

Date of IRB

2021 Year 09 Month 11 Day

Anticipated trial start date

2021 Year 09 Month 12 Day

Last follow-up date

2022 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study will be conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Electronic searches will be performed in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE databases, for studies conducted up to September 2021. The inclusion criteria are as follows: (1) the study must be designed as a randomized controlled trial, (2) the study must compare the physiotherapy and home-based program groups, (3) the study must include patients with rotator cuff repair, and (4) the study must report at least one outcome measure. The exclusion criteria are as follows: (1) studies different from randomized controlled trials, (2) randomized controlled trials that address a single type of intervention, and (3) studies including patients with other shoulder disorders (e.g., rotator cuff tendinopathy, fracture, shoulder impingement syndrome, and hemiplegic shoulder). Two reviewers will assess the quality of the studies independently. For assessing the risk of bias, the Cochrane risk-of-bias tool will be used for the randomized controlled trials. Meta-analyses will be performed to compare the functional outcomes of the physiotherapy and home-based program groups. Additionally, subgroup analyses and meta-regression analyses will be performed as needed. Subgroup analyses will be performed for the following comparisons: (1) age (above 60 years vs. below 60 years), (2) size of the rotator cuff tear (under 5 cm vs. over 5 cm), and (3) thickness of the tear (partial vs. full).


Management information

Registered date

2021 Year 09 Month 11 Day

Last modified on

2022 Year 09 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051897


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name