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 2024/01/14 15:22:45

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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

Email

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


Email

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

Email

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

Enrolling by invitation

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


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 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039430


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name