UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041077 |
|---|---|
| Receipt number | R000039430 |
| Scientific Title | To elucidat the pain mechanism in rotator cuff tear by conmapizon in the expression got paen related substances betwenn rotator cuff tear and chronic anterior shoulder instabilitu |
| Date of disclosure of the study information | 2020/07/25 |
| Last modified on | 2024/07/15 18:08:08 |
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Basic information
Public title
To elucidat the pain mechanism in rotator cuff tear by conmapizon in the expression got paen related substances betwenn rotator cuff tear and chronic anterior shoulder instabilitu
Acronym
Comparison in the expression of pain related substances between rotator cuff tear and chronic anterior syoulder instability.
Scientific Title
To elucidat the pain mechanism in rotator cuff tear by conmapizon in the expression got paen related substances betwenn rotator cuff tear and chronic anterior shoulder instabilitu
Scientific Title:Acronym
Comparison in the expression of pain related substances between rotator cuff tear and chronic anterior syoulder instability.
Region
| Japan |
Condition
Condition
rotatorr cuff tear and anterior shoulder instabilty
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate tha paein mechanism of the rotator cuff tearby comparizon with anterior shoulder dislocation.
Basic objectives2
Others
Basic objectives -Others
We compare the expression of the pein related substance by RT^PCR and ELISA method in synovium of shoulder joints
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Clinical score at before operation (Constant score, UCLA scale, Simple shoulder scale, VAS of pain)
Range of Motion (Flexion, Abduction, External rotation, Internal rotation)
mRNA level (TBF-alpha, IL-1beta, COX-2, NGF, Apelin NPFF, IL-6)
Key secondary outcomes
Base
Study type
Observational
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient with rotator cuff tear or anteriod shoulder instability determined by MRI
Key exclusion criteria
patients with frature around shoulder.
patients with RA or systemic inflammatory disease
patient treated with sterorid with in 1 month before operation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Kenmoku |
Organization
Kitasato University School of Medicine
Division name
Department of Orthopaedics Surgery
Zip code
252-0374
Address
Minami-ku 1-15-1, Sagamihara city Kanagawa
TEL
042-778-8111
pseudolefty811@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Kenmoku |
Organization
Kitasato University School of Medicine
Division name
Department of Orthopaedics Surgery
Zip code
252-0374
Address
Minami-ku 1-15-1, Sagamihara city Kanagawa
TEL
042-778-8111
Homepage URL
pseudolefty811@yahoo.co.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Medical Ethics Organization for Clinical Research
Address
Kitazato 1-15-1, minami-ku, Sagamihara city, Kanagawa, Japan
Tel
042-778-8111
rinrib@med.kitasato-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
北里大学医学部病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
COX-2: no significant difference between rotator cuff tear (RCT) and repetitive shoulder dislocation (RSD)
NGF: significantly elevated in RCT group Significant correlation between pain score and NGF expression
APELIN: significantly elevated in RCT group Significant correlation between pain score and expression of APELIN
Results date posted
| 2024 | Year | 01 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 08 | Month | 29 | Day |
Baseline Characteristics
Patients who have undergone surgery for rotator cuff tear or shoulder instability and who have consented to the study
Participant flow
The study was explained and consent obtained at the time of obtaining consent for surgery.
Adverse events
None
Outcome measures
Pain score by NRS, mRNA expression of pain-related substances in the synovial membrane by PCR, quantitative evaluation by Western-blot, Constant score, physical findings
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
case control study
Management information
Registered date
| 2020 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039430
