UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063265 |
|---|---|
| Receipt number | R000072416 |
| Scientific Title | Verify the differences in QST responses between those whose knee pain is and is not alleviated by spinal load |
| Date of disclosure of the study information | 2026/10/13 |
| Last modified on | 2026/10/13 23:55:35 |
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Basic information
Public title
Verify the differences in QST responses between those whose knee pain is and is not alleviated by spinal load
Acronym
Verify the differences in QST responses between those whose knee pain is and is not alleviated by spinal load
Scientific Title
Verify the differences in QST responses between those whose knee pain is and is not alleviated by spinal load
Scientific Title:Acronym
Verify the differences in QST responses between those whose knee pain is and is not alleviated by spinal load
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to clarify the differences in responses to quantitative sensory testing between individuals with knee pain who experience improvement through lumbar spine movement, and those who do not.
Basic objectives2
Others
Basic objectives -Others
The aim is to clarify the differences in responses to quantitative sensory testing between individuals with knee pain who experience improvement through lumbar spine movement, and those who do not.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The pressure pain threshold, temporal summation of pain and conditioned pain modulation are among the quantitative sensory tests measured before and after exercise.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Participants are asked to perform active lumbar extension from the prone position. We will measure pressure pain thresholds around the knee and on the forearm, as well as temporal summation of pain and conditioned pain modulation, both before and after exercise.
Interventions/Control_2
Participants are asked to perform active lumbar extension from the prone position. We will measure pressure pain thresholds around the knee and on the forearm, as well as temporal summation of pain and conditioned pain modulation, both before and after exercise.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals 18 years of age or older, individuals diagnosed with osteoarthritis of the knee and individuals who are capable of performing active lumbar extension exercises in a prone position.
Key exclusion criteria
Individuals who are pregnant or may be pregnant; individuals diagnosed with dementia or a mental illness; individuals diagnosed with a central nervous system disorder or an intractable neurological disease that may affect their ability to exercise; individuals experiencing pain in the shoulders, hips, lower back, or other areas that may prevent them from performing the planned exercises or meeting the required frequency; and individuals who have been advised by a doctor not to exercise
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Chiba |
Organization
Secomedic hospital
Division name
Department of rehabilitation
Zip code
274-0053
Address
696-1 Toyotomi-cho, Funabashi-shi, Chiba, Japan
TEL
047-457-9900
2591007o@spu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Chiba |
Organization
Secomedic hospital
Division name
Department of rehabilitation
Zip code
274-0053
Address
696-1 Toyotomi-cho, Funabashi-shi, Chiba, Japan
TEL
047-457-9900
Homepage URL
2591007o@spu.ac.jp
Sponsor or person
Institute
Secomedic hospital
Institute
Department
Personal name
Funding Source
Organization
Secomedic hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Secomedic hospital
Address
696-1 Toyotomi-cho, Funabashi-shi, Chiba, Japan
Tel
047-457-9900
2591007o@spu.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
| 2026 | Year | 10 | Month | 13 | 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 | 08 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 10 | Month | 13 | Day |
Last modified on
| 2026 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072416
