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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024537
Receipt No. R000028042
Scientific Title Effectiveness of Supervised Exercise Therapy for Community-dwelling People with Chronic Musculoskeletal Pain
Date of disclosure of the study information 2016/11/05
Last modified on 2019/05/08

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Basic information
Public title Effectiveness of Supervised Exercise Therapy for Community-dwelling People with Chronic Musculoskeletal Pain
Acronym Chronic Musculoskeletal Pain & Supervised Exercise Therapy
Scientific Title Effectiveness of Supervised Exercise Therapy for Community-dwelling People with Chronic Musculoskeletal Pain
Scientific Title:Acronym Chronic Musculoskeletal Pain & Supervised Exercise Therapy
Region
Japan

Condition
Condition Chronic Musculoskeletal Pain
Classification by specialty
Orthopedics Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effectiveness of supervised exercise therapy for community-dwelling people with chronic musculoskeletal pain.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Numeric Rating Scale (NRS)
Key secondary outcomes Self-Efficasy, Pain Self-Efficasy Questionnaire, etc.; Fear-avoidance belief, Tampa Scale for Kinesiophobia, etc.; Disease specific measure, Roland-Morris Disability Questionnaire, etc.; QOL, EuroQol 5 Dimension, etc.; motor function, grip strength, walk speed, muscle composition, and joint flexibility; cardiovascular risk factors, overweight, hypertension, hyperglycemia, hyperlipidemia, etc.; and depression, psychometric stress

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Supervised exercise therapy for musculoskeletal pain with textbook use, intervention period: about 1 month
Interventions/Control_2 only textbook use and/or usual care
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
40 years-old <=
Age-upper limit
74 years-old >=
Gender Male and Female
Key inclusion criteria Participants of annual health check survey, who have reported chronic musculoskeletal low back pain
Key exclusion criteria Specific musculoskeletal pain such as disc herniation, rheumatoid arthritis, and compressed fracture persisted for 3 months or less
Target sample size 48

Research contact person
Name of lead principal investigator
1st name Masahiko
Middle name
Last name Kiyama
Organization Osaka Center for Cancer and Cardiovascular Disease Prevention
Division name Osaka Center for Cancer and Cardiovascular Disease Prevention
Zip code 536-8588
Address 1-3-2 Nakamichi, Higashinari-ku, Osaka, Japan
TEL +81-6-6969-6922
Email kiyama@osaka-ganjun.jp

Public contact
Name of contact person
1st name Hiroyasu
Middle name
Last name Iso
Organization Osaka University Graduate School of Medicine
Division name Public Health
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL +81-6-6879-3911
Homepage URL
Email iso@pbhel.med.osaka-u.ac.jp

Sponsor
Institute Osaka Center for Cancer and Cardiovascular Disease Prevention
Institute
Department

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

Other related organizations
Co-sponsor Osaka University Graduate School of Medicine / 22nd Century Medical and Research Center, The University of Tokyo
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Center for Translational and Clinical Research Osaka University Hospital
Address 2-2 Yamadaoka, Suita, Osaka, Japan
Tel +81-6210-8290
Email shiken@hp-crc.med.osaka-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
2016 Year 11 Month 05 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 52
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 No longer recruiting
Date of protocol fixation
2016 Year 11 Month 04 Day
Date of IRB
2016 Year 10 Month 28 Day
Anticipated trial start date
2016 Year 11 Month 05 Day
Last follow-up date
2018 Year 07 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
2016 Year 10 Month 24 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028042

Research Plan
Registered date File name
2017/05/11 提出用_研究計画書(様式 2)_慢性運動器痛と運動療法v4.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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