UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The investigation about nature of rotator cuff pain
Title of the study (Brief title)	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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Ikeuchi Masahiko
Organization	Kochi Medical School Hospital
Division name	Department of Orthopedic Surgery in Kochi Medical School
Address	Nankokussi Okocho Kohasu 185-1
TEL	088-866-5811
Email	maximum8530@yahoo.co.jp

Public contact
Name of contact person	Toyonaga Takuya
Organization	Kochi Joto Hospital
Division name	rehabilitationbu
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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