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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038850
Receipt No. R000044306
Scientific Title Effects of chronic exercise on pain sensitivity and subjective pain symptom in people with chronic pain
Date of disclosure of the study information 2019/12/13
Last modified on 2020/06/11

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Basic information
Public title Effects of chronic exercise on pain sensitivity and subjective pain symptom in people with chronic pain
Acronym Chronic exercise-induced hypoalgesia
Scientific Title Effects of chronic exercise on pain sensitivity and subjective pain symptom in people with chronic pain
Scientific Title:Acronym Chronic exercise-induced hypoalgesia
Region
Japan

Condition
Condition Chronic neck/shoulder, low back and knee pain
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the effects of chronic exercise on pain sensitivity and subjective pain symptoms in people with chronic musculoskeletal pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1) Subjective pain
2) Quantitative sensory testing
Key secondary outcomes 1) Physical disability
2) Physical activity
3) Mood

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Aerobic exercise (cycling) three times per week for 4 weeks
Interventions/Control_2 No treatment
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
18 years-old <=
Age-upper limit
23 years-old >=
Gender Male and Female
Key inclusion criteria We will include persons with neck and shoulder pain, low back pain or knee pain lasted > 3 months and their maximum intensity > 20 mm on VAS for a week.
Key exclusion criteria Receiving medical treatment for pain, taking medication, pregnancy, history of surgery, cardiovascular or metabolic disease, contraindication to exercise.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takako
Middle name
Last name Matsubara
Organization Kobe Gakuin University
Division name Graduate School of Rehabilitation
Zip code 651-2180
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180 JAPAN
TEL (078)974-1551
Email matsubar@reha.kobegakuin.ac.jp

Public contact
Name of contact person
1st name Takako
Middle name
Last name Matsubara
Organization Kobe Gakuin University
Division name Graduate School of Rehabilitation
Zip code 651-2180
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180 JAPAN
TEL (078)974-1551
Homepage URL
Email matsubar@reha.kobegakuin.ac.jp

Sponsor
Institute Kobe Gakuin University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Review Board for Medical and Health Research Involving Human Subjects on Faculty of Rehabilitation, Kobe Gakuin University
Address 518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180 JAPAN
Tel (078)974-4127
Email ethic@reha.kobegakuin.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 神戸学院大学(兵庫県)/Kobe Gakuin University(Hyogo)

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 13 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
2019 Year 06 Month 05 Day
Date of IRB
2019 Year 11 Month 19 Day
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2020 Year 10 Month 31 Day
Date of closure to data entry
2020 Year 10 Month 31 Day
Date trial data considered complete
2020 Year 11 Month 01 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 12 Month 11 Day
Last modified on
2020 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044306

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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