UMIN-CTR Clinical Trial

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