UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049973 |
|---|---|
| Receipt number | R000055795 |
| Scientific Title | Assessment of locomotive syndrome using objective pain assessment device |
| Date of disclosure of the study information | 2023/01/10 |
| Last modified on | 2023/09/02 23:44:03 |
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Basic information
Public title
Study using PAINVISION to assess the presence of locomotive syndrome
Acronym
Assessment locomotive syndrome using PAINVISION
Scientific Title
Assessment of locomotive syndrome using objective pain assessment device
Scientific Title:Acronym
Assessment of locomotive syndrome using objective pain
Region
| Japan |
Condition
Condition
chronic low backpain, chronic knee osteoarthritis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The two groups, divided by the presence or absence of locomotive syndrome, are compared in terms of pain degrees as measured by Pain Vision.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between the presence of locomotive syndrome and pain degrees.
Key secondary outcomes
Base
Study type
Observational
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with lower back and lower limb pain due to musculoskeletal conditions with chronic pain
Key exclusion criteria
psychiatric disorders or psychosocial pain, cognitive dysfunctions, non-motor pain, gait disturbance due to paralysis or weakness other than pain, history of surgery for musculoskeletal disorders of the lower back and lower limbs, under 18 years of age, history of surgery for musculoskeletal disorders of the lower back and lower limbs.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Yamada |
Organization
School of medicine, Iwate medical university
Division name
Department of anesthesiology
Zip code
028-3695
Address
2-1-1, idai-dori, Yahaba-cho, Shiwa-gun, Iwate, 028-3695
TEL
0196137111
ymd1360@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Miyake |
Organization
School of medicine, Iwate medical university
Division name
Department of anesthesiology
Zip code
028-3695
Address
2-1-1, idai-dori, Yahaba-cho, Shiwa-gun, Iwate, 028-3695
TEL
0196137111
Homepage URL
ymd1360@yahoo.co.jp
Sponsor or person
Institute
School of medicine, Iwate medical university
Institute
Department
Personal name
Funding Source
Organization
School of medicine, Iwate medical university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
School of medicine, Iwate medical university
Address
2-1-1, idai-dori, Yahaba-cho, Shiwa-gun, Iwate, 028-3695
Tel
0196137111
kenkyurinri@j.iwate-med.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
| 2023 | Year | 01 | Month | 10 | 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
30
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
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2023 | Year | 01 | Month | 06 | Day |
Last modified on
| 2023 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055795
