UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023943 |
|---|---|
| Receipt number | 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 | 2021/03/11 13:05:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
im35@kochi-u.ac.jp
Sponsor or person
Institute
Department of Orthopedic surgery, Kochi Medical School, Kochi University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
