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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022039
Receipt No. R000025404
Scientific Title The investigation about nature of rotator cuff pain
Date of disclosure of the study information 2016/04/24
Last modified on 2016/04/24

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Basic information
Public title The investigation about nature of rotator cuff pain
Acronym The nature of rotator cuff pain
Scientific Title The investigation about nature of rotator cuff pain
Scientific Title:Acronym The nature of rotator cuff pain
Region
Japan

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

Objectives
Narrative objectives1 Pain is the most frequently cited symptom associated with rotator cuff tear (RCT) and surgery is often indicated for patients with severe pain. On the other hand it is well known that many people in the general population have an asymptomatic RCT. These facts indicate that etiology and mechanism of rotator cuff pain is not fully known. The aim of this experimental study is to investigate characteristics of rotator cuff pain.

Basic objectives2 Others
Basic objectives -Others Rotator cuff pain is to investigate potential for modulating muscle strength around the shoulder.

Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes >Pain intensity(VAS)
Key secondary outcomes >Pain distribution(Pain drawing)
>Pain Quarity(McGill Pain Questionnaire)
>shoulder strength(abduction,inteinal rotation,external rotation,grip)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Nunber of the investigation:two times
Frequency of the intervention:Once a week
Time for the investigation:two hours
Quantity of the intervention:isotonic saline(0.9%,0.5ml),hypertonic saline(5.8%,0.5ml)
Interventions/Control_2 Nunber of the investigation:two times
Frequency of the intervention:Once a week
Time for the investigation:two hours
Quantity of the intervention:isotonic saline(0.9%,0.5ml),hypertonic saline(5.8%,0.5ml)
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
20 years-old <=
Age-upper limit
40 years-old >
Gender Male
Key inclusion criteria The person who was agreed with in study contents
Key exclusion criteria > The exercise caliber (shoulder,waist,knee etc) is painful
>It is taked antiphlogistic balm (or it is necessary to take medicine during an examination)
>It is treated for psychiatry or psychosomatic medicine
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikeuchi Masahiko
Organization Kochi Medical School Hospital
Division name Department of Orthopedic Surgery in Kochi Medical School
Zip code
Address Nankokussi Okocho Kohasu 185-1
TEL 088-866-5811
Email maximum8530@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toyonaga Takuya
Organization Kochi Joto Hospital
Division name rehabilitationbu
Zip code
Address Kochi Otsu otsu 719
TEL 090-5276-9750
Homepage URL
Email maximum8530@yahoo.co.jp

Sponsor
Institute Department of Orthopedic Surgery in Kochi Medical School
Institute
Department

Funding Source
Organization Department of Orthopedic Surgery in Kochi Medical School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 04 Month 24 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
2015 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 24 Day
Last modified on
2016 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025404

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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