UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044080 |
|---|---|
| Receipt number | R000050330 |
| 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 |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2022/05/01 09:53:44 |
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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
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
t3tanaka@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050330
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
