UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063500 |
|---|---|
| Receipt number | R000071735 |
| Scientific Title | Comparing the effects of insoles with and without resin parts on low back and body fatigue |
| Date of disclosure of the study information | 2026/11/02 |
| Last modified on | 2026/11/02 16:27:46 |
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Basic information
Public title
Comparing the effects of insoles with and without resin parts on low back and body fatigue
Acronym
Insole and Low Back Fatigue Study
Scientific Title
Comparing the effects of insoles with and without resin parts on low back and body fatigue
Scientific Title:Acronym
Insole and Low Back Fatigue Study
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of using posture-support insoles with and without resin parts for 3 months on low back pain and whole-body fatigue
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in NRS low back pain score from baseline to 3 months after starting insole use
Key secondary outcomes
Change in NRS low back pain score at 1 and 2 months
Change in NRS whole-body fatigue score at each time point (1-6 months)
Within the group that used the insole without resin parts first, the difference between the change from baseline to 3 months and the change from 3 to 6 months in NRS low back pain and whole-body fatigue scores
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants wear an insole with resin parts during work for the first 3 months, then switch to an insole without resin parts for the following 3 months (months 4-6).
Interventions/Control_2
Participants wear an insole without resin parts during work for the first 3 months, then switch to an insole with resin parts for the following 3 months (months 4-6).
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Nurses or nursing assistants working at Japanese Red Cross Kobe Hospital who meet all of the following criteria:
1.Spend a large proportion of working hours in a standing position
2.Have habitual subjective awareness of low back pain
3.Provide informed consent to participate in the study
Key exclusion criteria
Individuals meeting any of the following criteria:
1.Currently using insoles or specialized footwear on a daily basis
2.Currently undergoing treatment for a structural lumbar disorder (e.g., disc herniation, spinal canal stenosis)
3.Pregnant
4.Planned to take leave or resign during the study period
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kuniyasu |
| Middle name | |
| Last name | Kamiya |
Organization
Kobe City College of Nursing
Division name
Faculty of Nursing
Zip code
651-2103
Address
3-4 Gakuenishimachi, Nishi-ku, Kobe-shi, Hyogo
TEL
0787948080
kuniyasu-kamiya@kobe-ccn.ac.jp
Public contact
Name of contact person
| 1st name | Kuniyasu |
| Middle name | |
| Last name | Kamiya |
Organization
Kobe City College of Nursing
Division name
Faculty of Nursing
Zip code
651-2103
Address
3-4 Gakuenishimachi, Nishi-ku, Kobe-shi, Hyogo
TEL
0787948080
Homepage URL
kuniyasu-kamiya@kobe-ccn.ac.jp
Sponsor or person
Institute
Kobe City College of Nursing
Institute
Department
Personal name
Kuniyasu Kamiya
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Japanese Red Cross Kobe Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe City College of Nursing
Address
3-4 Gakuenishimachi, Nishi-ku, Kobe-shi, Hyogo
Tel
0787948080
rinri@kobe-ccn.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
神戸赤十字病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 02 | 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
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 11 | Month | 02 | Day |
Last modified on
| 2026 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071735
