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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023943
Receipt No. R000027570
Scientific Title Pain profile and innervation characteristics originating from long head of biceps tendon in patients with rotator cuff tear 2.clinical study
Date of disclosure of the study information 2016/09/06
Last modified on 2019/09/14

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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 Open public recruiting
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
2019 Year 09 Month 14 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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