UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040820 |
|---|---|
| Receipt number | R000044961 |
| Scientific Title | Research on the Association Between Fostering Self-Management and Neuromodulators Among Community-Dwelling People with Chronic Musculoskeletal Pain |
| Date of disclosure of the study information | 2020/06/27 |
| Last modified on | 2021/06/21 12:01:28 |
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Basic information
Public title
Community-Based Epidemiological Study on the Effect of Individualized Self-Management Support of Low Back Pain After Health Check
Acronym
Community-Based Epidemiological Study on the Effect of Individualized Self-Management Support of Low Back Pain After Health Check
Scientific Title
Research on the Association Between Fostering Self-Management and Neuromodulators Among Community-Dwelling People with Chronic Musculoskeletal Pain
Scientific Title:Acronym
Research on the Association Between Fostering Self-Management and Neuromodulators Among Community-Dwelling People with Chronic Musculoskeletal Pain
Region
| Japan |
Condition
Condition
Chronic low back pain
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is a randomized controlled trial of middle-aged and older community people with chronic low back pain to assess that pain self-management education improves pain symptoms and change levels of neuromodulator such as serum beta-endorphin and serotonin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of low back pain (RDQ)
Key secondary outcomes
Pain intensity (NRS)
Pain self-efficacy (PSEQ)
Serum neuromodulators
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Self-exercise and pain education
Interventions/Control_2
Control (waiting-list control)
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People i) with low back pain persisting for at least 3 months at the time of the survey, ii) aged 40-79 years, and iii) with provision of informed consent to participate in the study.
Key exclusion criteria
People i) with suspected specific low back pain (e.g. intervertebral disc herniation, and spinal compression fracture), ii) with severe neurologic deficits, iii) who use of selective serotonin reuptake inhibitors or antidepressants, iv) who could not accommodate the study schedule, v) with a scheduled move or long-term trip within a year, vi) with difficulty comprehending the Japanese language, vii) with obvious cognitive impairment which would make difficult to answer the questionnaires and/or to provide consent, or viii) who were deemed ineligible by a public health or orthopedic doctor.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Hiroshige |
| Middle name | |
| Last name | Jinnnouchi |
Organization
Nippon Medical School
Division name
Department of Hygiene and Public Health
Zip code
113-0031
Address
1-25-16 Nezu, Bunkyo-Ku, Tokyo
TEL
03-3822-2131
h-jinnouchi@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshige |
| Middle name | |
| Last name | Jinnouchi |
Organization
Nippon Medical School
Division name
Department of Hygiene and Public Health
Zip code
113-0031
Address
1-25-16 Nezu, Bunkyo-Ku, Tokyo
TEL
03-3822-2131
Homepage URL
h-jinnouchi@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Center for Cancer and Cardiovascular Disease Prevention
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Nippon Medical School
Address
1-1-5 Sendagi, Bunkyo-Ku, Tokyo
Tel
03-3822-2131
nms_rinri@nms.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 | 06 | Month | 27 | 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 | 01 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 12 | 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 | 06 | Month | 18 | Day |
Last modified on
| 2021 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044961
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
