UMIN-CTR Clinical Trial

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
Email	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
Email	h-jinnouchi@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044961