UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024537 |
|---|---|
| Receipt number | 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 | 2021/06/14 19:21:03 |
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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
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
iso@pbhel.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka Center for Cancer and Cardiovascular Disease Prevention
Institute
Department
Personal name
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
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
https://www.jstage.jst.go.jp/article/ssrr/advpub/0/advpub_2019-0005/_article/-char/ja/
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/14397595.2020.1823603
Number of participants that the trial has enrolled
52
Results
The brief-See did not show additional improvement over material-based education on the NRS, but it did on the RDQ, PSEQ, and EQ-5D; the estimated mean group differences in changes from the baseline were -2.1 (-3.5 to -0.7, P=0.005) on the RDQ, 6.9 (1.7 to 12.1, P=0.010) on the PSEQ, and 0.07 (0.02 to 0.12, P=0.004) on the EQ-5D.
Results date posted
| 2019 | Year | 10 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Middle-aged and older adults with chronic low back pain in a community.
Participant flow
We systematically recruited 252 eligible persons from a community (Ikawa, located in northeastern Japan) via an annual cardiovascular risk survey as part of the CIRCS, and identified 52 participants who applied voluntarily.
Adverse events
No notable adverse events were observed.
Outcome measures
NRS, RDQ, PSEQ, and EQ-5D
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.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 |
