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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046021
Receipt No. 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 2021/11/01

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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
Email 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
Email drugsatou@gmail.com

Sponsor
Institute Graduate School of Medicine, Tohoku University
Institute
Department

Funding Source
Organization Ministry of Education
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 Graduate School of Medicine, Tohoku University
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
Tel 022717738
Email drugsatou@gmail.com

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
2021 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052442

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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