UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023942 |
|---|---|
| Receipt number | R000027568 |
| Scientific Title | Pain profile and innervation characteristics originating from long head of biceps tendon in patients with rotator cuff tear 1.experimental human pain model study |
| Date of disclosure of the study information | 2016/09/06 |
| Last modified on | 2018/03/29 22:08:39 |
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Basic information
Public title
Pain profile and innervation characteristics originating from long head of biceps tendon in patients with rotator cuff tear
1.experimental human pain model study
Acronym
Pain profile originating from long head of biceps tendon
1.experimental human pain model study
Scientific Title
Pain profile and innervation characteristics originating from long head of biceps tendon in patients with rotator cuff tear
1.experimental human pain model study
Scientific Title:Acronym
Pain profile originating from long head of biceps tendon
1.experimental human pain model study
Region
| Japan |
Condition
Condition
Rotator cuff tear
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify a pain profile of Long Head of Biceps Tendon(LHBT)
Basic objectives2
Others
Basic objectives -Others
To establish a system that help evaluating a necessity and validity of LHBT resection in patients with rotator cuff tear
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain profile immediately after hypertonic saline injection (intensity, duration, and distribution)
Key secondary outcomes
Pressure pain threshold, Muscle strength, positive rate of clinical LHBT pain tests
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
| Other |
Interventions/Control_1
Subjects will be injected hypertonic saline (5.8%, 0.3ml) into LHBT.
Interventions/Control_2
Isotonic saline (0.9%, 0.3ml) will be injected contralaterally in the same session as control.
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
Healthy male who does not meet exclusion criteria
Key exclusion criteria
1) History of chronic musculoskeletal pain
2) History of shoulder surgery
3) History of nerve injury
4) Taking pain killers orally (or need to take them during experiment)
5) Psychiatric disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Izumi |
Organization
Kochi Medical School, Kochi University
Division name
Department of Orthopedic surgery
Zip code
Address
185-1, Kohasu, Oko-cho, Nankoku city, Japan
TEL
088-880-2386
izumim@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miho Taniuchi |
Organization
Kochi Medical School, Kochi University
Division name
Department of Orthopedic surgery
Zip code
Address
185-1, Kohasu, Oko-cho, Nankoku city, Japan
TEL
088-880-2386
Homepage URL
im35@kochi-u.ac.jp
Sponsor or person
Institute
Department of Orthopedic surgery, Kochi Medical School, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology Grants-in-Aid for scientific research <KAKENHI>
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 09 | Month | 06 | 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
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 08 | 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 | 09 | Month | 06 | Day |
Last modified on
| 2018 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027568
