UMIN-CTR Clinical Trial

Basic information
Public title	Pain profile and innervation characteristics originating from long head of biceps tendon in patients with rotator cuff tear 2.clinical study
Acronym	Pain profile and innervation characteristics originating from long head of biceps tendon in patients with rotator cuff tear 2.clinical study
Scientific Title	Pain profile and innervation characteristics originating from long head of biceps tendon in patients with rotator cuff tear 2.clinical study
Scientific Title:Acronym	Pain profile and innervation characteristics originating from long head of biceps tendon in patients with rotator cuff tear 2.clinical study
Region	Japan

Condition
Condition	Rotator cuff tear
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify a possibility of pain source of LHBT in patients with rotator cuff tear
Basic objectives2	Others
Basic objectives -Others	To establish a system that help evaluating a necessity and validity of LHBT resection in patients with rotator cuff tear
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Density of pain related molecules expressed in resected LHBT
Key secondary outcomes	Relationship between the density of pain related molecules expressed in resected LHBT and preoperative clinical data

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Immunohistochemical evaluation of resected LHBT and peritendinous synovium in patients undergoing arthroscopic rotator cuff repair
Interventions/Control_2	Immunohistochemical evaluation of synovium around LHBT in patients undergoing arthroscopy for non-painful shoulder disease (Control)
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	60 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with isolated supraspinatus tendon tear undergoing arthroscopic rotator cuff repair (30 cases) Control: Patients undergoing arthroscopy for non-painful shoulder disease (10 cases)
Key exclusion criteria	1)Systemic painful disease (Rheumatoid arthritis, multiple osteoarthritis) 2)Diabetes 3)Dementia 4)Re-operation 5)Traumatic rotator cuff tear with a definite onset 6)Arthroscopically no degenerative change and inflammation in LHBT
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Masashi Middle name Last name Izumi
Organization	Kochi Medical School, Kochi University
Division name	Department of Orthopedic surgery
Zip code	783-8505
Address	185-1, Kohasu, Oko-cho, Nankoku city, Japan
TEL	088-880-2386
Email	izumim@kochi-u.ac.jp

Public contact
Name of contact person	1st name Miho Middle name Last name Taniuchi
Organization	Kochi Medical School, Kochi University
Division name	Department of Orthopedic surgery
Zip code	783-8505
Address	185-1, Kohasu, Oko-cho, Nankoku city, Japan
TEL	088-880-2386
Homepage URL
Email	im35@kochi-u.ac.jp

Sponsor
Institute	Department of Orthopedic surgery, Kochi Medical School, Kochi University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology Grants-in-Aid for scientific research <KAKENHI>
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kochi Medical School
Address	Kohasu, Oko-cho, Nankoku
Tel	088-880-2386
Email	im35@kochi-u.ac.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	2016 Year 09 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
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 09 Month 01 Day
Date of IRB	2016 Year 08 Month 03 Day
Anticipated trial start date	2016 Year 09 Month 08 Day
Last follow-up date	2020 Year 03 Month 31 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 09 Month 06 Day
Last modified on	2021 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027570