UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022039 |
|---|---|
| Receipt number | 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 17:01:27 |
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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
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
maximum8530@yahoo.co.jp
Sponsor or person
Institute
Department of Orthopedic Surgery in Kochi Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025404
