UMIN-CTR Clinical Trial

Basic information
Public title	Adduction manipulation of the glenohumeral joint vs. physiotherapy for degenerative rotator cuff tears.
Acronym	Utility of adduction manipulation for degenerative rotator cuff tears
Scientific Title	Adduction manipulation of the glenohumeral joint vs. physiotherapy for degenerative rotator cuff tears.
Scientific Title:Acronym	Utility of adduction manipulation for degenerative rotator cuff tears
Region	Japan

Condition
Condition	Degenerative rotator cuff tears
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to compare clinical outcomes between adduction manipulation and physiotherapy with a randomized controlled study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The American Shoulder and Elbow Surgeons (ASES) and Constant scores at the initial baseline visit and at the 1-, 3-, 6-, and 12- month follow-ups.
Key secondary outcomes	The visual analog scale (VAS), range of motion (ROM; such as flexion, abduction, external rotation, and internal rotation) at the initial baseline visit and at the 1-, 3-, 6-, and 12- month follow-ups.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Perform an adduction manipulation for the shoulder joint after diagnosis by MRI.
Interventions/Control_2	Perform standard physiotherapy by two physical therapists, as a specialist for shoulder disorders.
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Between April 2017 and March 2019, we enrolled patients in the trial, who complained of shoulder joint pain and presented rotator cuff tears with magnetic resonance imaging (MRI). 2) The inclusion criteria for patients with symptomatic degenerative rotator cuff tears were persistent symptoms for less than 6 months and normal radiologic appearance.
Key exclusion criteria	The exclusion criteria were an acute injury, already having undergone nonoperative or surgical treatment, substantial cervical pathology or radiculopathy, concomitant pathology of the affected shoulder (including instability, dislocation, acromioclavicular osteoarthritis, and scapular dyskinesia), systemic inflammation, and metabolic disorders such as rheumatoid arthritis and diabetes mellitus.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Junichiro Middle name Last name Hamada
Organization	Kuwano Kyoritsu Hospital
Division name	Department of Orthopaedic Surgery
Zip code	963-8034
Address	2-9-18 Shima, Koriyama, Fukushima, Japan
TEL	024-933-5422
Email	i-hamada@koriyama-h-coop.or.jp

Public contact
Name of contact person	1st name Junichiro Middle name Last name Hamada
Organization	Kuwano Kyoritsu Hospital
Division name	Department of Orthopaedic Surgery
Zip code	963-8034
Address	2-9-18 Shima, Koriyama, Fukushima, Japan
TEL	024-933-5422
Homepage URL
Email	i-hamada@koriyama-h-coop.or.jp

Sponsor
Institute	Kuwano Kyoritsu Hospital
Institute
Department

Funding Source
Organization	Kuwano Kyoritsu Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Josai International University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of Kuwano Kyoritsu Hospital
Address	2-9-18 Shima, Koriyama, Fukushima, 963-8034, Japan
Tel	024-933-5422
Email	sei_ojimaa@koriyama-h-coop.or.jp

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 08 Month 06 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	159
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	2017 Year 04 Month 01 Day
Date of IRB	2017 Year 03 Month 19 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 08 Month 06 Day
Last modified on	2021 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051483