UMIN-CTR Clinical Trial

Basic information
Public title	The effect of non-surgical interventions on pain relief and symptom improving in farmers with diseases of the musculoskeletal system or connective tissue
Acronym	The effect of interventions on pain relief and symptom improving in farmers
Scientific Title	The effect of non-surgical interventions on pain relief and symptom improving in farmers with diseases of the musculoskeletal system or connective tissue: an exploratory systematic review based on randomized controlled trials
Scientific Title:Acronym	The effect of non-surgical interventions in farmers with diseases of the musculoskeletal system or connective tissue: an exploratory systematic review
Region	Japan

Condition
Condition	Diseases of the musculoskeletal system or connective tissue
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objectives of this review is to summarize the evidence for the effects of non-surgical interventions on pain relief and symptom improving in farmers with diseases of the musculoskeletal system or connective tissue.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Pain relief and improving symptom and quality of life, and improving physical fitness. The former includes subjective pain, symptom, number of medication, analgesic and/or non-steroidal anti-inflammatory drugs (NSAIDs) consumption, and improving quality of life (QOL). The latter includes muscle strength, stiffness and tender joint, balance, gait speed, aerobic capacity, mobility, and whole or partial function.
Key secondary outcomes	Nothing.

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Studies are eligible if they were RCTs (including quasi-RCTs). The styles are targeted for both parallel groups and crossover.
Key exclusion criteria	Interventions that used specific equipment such as electrotherapy and ultra-sound therapy cannot be performed by patients themselves are excluded.
Target sample size

Research contact person
Name of lead principal investigator	1st name Hiroharu Middle name Last name Kamioka
Organization	Tokyo University of Agriculture
Division name	Department of Ecological Symbiotic Science, Graduate School of Agriculture
Zip code	156-8502
Address	Sakuragaoka 1-1-1, Setagaya-ku, Tokyo
TEL	0354772587
Email	h1kamiok@nodai.ac.jp

Public contact
Name of contact person	1st name Toshiki Middle name Last name Tanaka
Organization	Tokyo University of Agriculture
Division name	Research Institute
Zip code	156-8502
Address	Sakuragaoka 1-1-1,Setagaya-ku, Tokyo
TEL	0354772562
Homepage URL
Email	t3tanaka@nodai.ac.jp

Sponsor
Institute	Tokyo University of Agriculture
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research Number 20K06285 from the Ministry of Education, Culture, Sports, Science and Technology (MEXT), Japan.
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyo University of Agriculture
Address	Sakuragaoka 1-1-1, Setagaya-ku, Tokyo
Tel	0354772562
Email	t3tanaka@nodai.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	2021 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8753261/pdf/jrm-17-001.pdf
Number of participants that the trial has enrolled	4
Results	Four studies (three on low back pain and one on knee osteoarthritis) met all the inclusion criteria. Overall, the risk of bias was high, and meta-analysis could not be performed due to heterogeneity. However, a participatory ergonomic approach, exercise centered on strength training with a transtheoretical model, and/or a combination of both could be included in effective educational programs, at least in the short term, to prevent and/or reduce exacerbation.
Results date posted	2022 Year 05 Month 01 Day
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	Completed
Date of protocol fixation	2021 Year 02 Month 08 Day
Date of IRB	2021 Year 02 Month 01 Day
Anticipated trial start date	2021 Year 02 Month 20 Day
Last follow-up date	2021 Year 05 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We registered for the trial with the PROSPERO on February 10, 2021 in advance, but for some reason it was not posted on the homepage. Therefore, although the research was in the middle of implementation, we registered with the UMIN-CTR.

Management information
Registered date	2021 Year 04 Month 30 Day
Last modified on	2022 Year 05 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050330