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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041748
Receipt No. R000045673
Scientific Title Verification of exercise induced hypoalgesia from aerobic exercise in patients with shoulder pain
Date of disclosure of the study information 2020/09/11
Last modified on 2020/09/10

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Basic information
Public title Verification of exercise induced hypoalgesia from aerobic exercise in patients with shoulder pain
Acronym Verification of exercise induced hypoalgesia from aerobic exercise in patients with shoulder pain
Scientific Title Verification of exercise induced hypoalgesia from aerobic exercise in patients with shoulder pain
Scientific Title:Acronym Verification of exercise induced hypoalgesia from aerobic exercise in patients with shoulder pain
Region
Japan

Condition
Condition Patients with shoulder pain
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify exercise induced hypoalgesia effect from aerobic exercise in patients with shoulder pain

To investigate the relationship between pain sensitization and exercise induced hypoalgesia from aerobic exercise in patients with shoulder pain
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Shoulder motion pain and Pressure Pain Threshold(PPT)before and after aerobic exercise
Key secondary outcomes Relationship among pain sensitization parameters(pressure pain threshold: PPT,temporal summation of pain: TS and conditioned pain modulation: CPM)and Exercise induced hypoalgesia(EIH)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Aerobic exercise
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients with shoulder pain
Key exclusion criteria 1.acute inflammatory condition (ex. trauma, infection)
2.post-surgical pain within 6 months
3.skin disorders around pain assessment area
4.Psychological disorders (ex. dementia)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Tomoki
Middle name
Last name Horino
Organization Kochi Medical School Hospital
Division name Department of Rehabilitation Center
Zip code 783-8505
Address Oko-cho Kohasu, Nankoku, Kochi, Japan 783-8505
TEL 088-880-2490
Email Jm-horino_tomoki@kochi-u.ac.jp

Public contact
Name of contact person
1st name Tomoki
Middle name
Last name Horino
Organization Kochi Medical School Hospital
Division name Department of Rehabilitation Center
Zip code 783-8505
Address Oko-cho Kohasu, Nankoku, Kochi, Japan 783-8505
TEL 088-880-2490
Homepage URL
Email Jm-horino_tomoki@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School Hospital
Institute
Department

Funding Source
Organization None
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 Kochi Medical School Hospital
Address Oko-cho Kohasu, Nankoku, Kochi, Japan 783-8505
Tel 088-880-2490
Email Jm-horino_tomoki@kochi-u.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
2020 Year 09 Month 11 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
2020 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 05 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 09 Month 10 Day
Last modified on
2020 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045673

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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