UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046021 |
|---|---|
| Receipt number | R000052442 |
| Scientific Title | Changes in interhemispheric inhibition in patients with lateral epicondylitis of the elbow |
| Date of disclosure of the study information | 2021/11/15 |
| Last modified on | 2023/05/12 13:20:35 |
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Basic information
Public title
Changes in interhemispheric inhibition in patients with lateral epicondylitis of the elbow
Acronym
Changes in interhemispheric inhibition in patients with lateral epicondylitis of the elbow
Scientific Title
Changes in interhemispheric inhibition in patients with lateral epicondylitis of the elbow
Scientific Title:Acronym
Changes in interhemispheric inhibition in patients with lateral epicondylitis of the elbow
Region
| Japan |
Condition
Condition
Lateral epicondylitis of the elbow
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the neural mechanisms of Lateral epicondylitis of the elbow.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ipsilateral Silent Period(iSP):
The iSP is thought to reflect the inhibitory input to the contralateral hemisphere motor cortex via the corpus callosum. In iSP, magnetic stimulation to the motor cortex of the hemisphere ipsilateral to the moving upper limb temporarily increases inhibitory input from the ipsilateral hemisphere to the contralateral hemisphere, resulting in suppression of muscle activity. The duration and degree of suppression by the stimulation are used as an index of iSP.
In this study, we measure the duration of the suppression of the muscle activity was the primary endpoint.
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients with right lateral epicondylitis
(2) Right-handed
Key exclusion criteria
(1) History of surgery on the right elbow joint
(2) History of neurological disease
(3) History of epilepsy
(4) Pregnant
(5) Presence of metal in the body
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Shin-Ichi |
Organization
Graduate School of Medicine, Tohoku University
Division name
Department of Physical Medicine and Rehabilitation
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022717738
reha@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Sato |
Organization
Graduate School of Medicine, Tohoku University
Division name
Department of Physical Medicine and Rehabilitation
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022717738
Homepage URL
drugsatou@gmail.com
Sponsor or person
Institute
Graduate School of Medicine, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medicine, Tohoku University
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
Tel
022717738
reha@med.tohoku.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 11 | Month | 15 | 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
In this study, we compare iSP in patients with lateral epicondylitis and healthy controls to determine whether abnormal interhemispheric inhibition occurs in patients.
Management information
Registered date
| 2021 | Year | 11 | Month | 09 | Day |
Last modified on
| 2023 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052442
