UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039723 |
|---|---|
| Receipt number | R000045303 |
| Scientific Title | Central pain modulation and exercise-induced hypoalgesia in Japanese patients with osteoarthritis. |
| Date of disclosure of the study information | 2020/03/06 |
| Last modified on | 2026/09/09 16:37:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Central pain modulation and exercise-induced hypoalgesia in Japanese patients with osteoarthritis.
Acronym
Central pain modulation in osteoarthritis patients.
Scientific Title
Central pain modulation and exercise-induced hypoalgesia in Japanese patients with osteoarthritis.
Scientific Title:Acronym
Central pain modulation in osteoarthritis patients.
Region
| Japan |
Condition
Condition
Knee and hip osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyse of conditions of central pain modulation and investigate exercise-induced hypoalgesia in Japanese patients with knee and hip osteoarthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Subjective pain, 2) Quantitative sensory testing
Key secondary outcomes
Physical function
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Behavioral graded activity
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Female sex
Age over 50 years
Radiographically confirmed knee osteoarthritis (KOA): Kellgren Lawrence (KL) grade 2 or higher
Persistent knee pain for more than 6 months
Non-response despite a 3-month guideline-concordant exercise program
Key exclusion criteria
Systemic inflammatory diseases (e.g., rheumatoid arthritis)
Cognitive impairment
Severe medical comorbidities (e.g., neurological disorders; neuropsychiatric disorders such as depression or autism; cardiovascular diseases; cancer)
Serious hip or ankle pathology (e.g., osteoarthritis; unhealed fractures)
Leg pain referred from the lumbar spine
Previous joint replacement
Use of centrally acting medications (e.g., antidepressants; anxiolytics)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Matsubara |
Organization
Kobe Gakuin University
Division name
Graduate School of Rehabilitation
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180, JAPAN
TEL
(078)974-1551
matsubar@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Matsubara |
Organization
Kobe Gakuin University
Division name
Graduate School of Rehabilitation
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180, JAPAN
TEL
(078)974-1551
Homepage URL
matsubar@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Maehara Orthopedic Rehabilitation Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe Gakuin University
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180, JAPAN
Tel
(078)974-4127
ethic@reha.kobegakuin.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
神戸学院大学（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
32
Results
Twenty-six participants completed the intervention. Linear mixed models showed significant improvements in KOOS pain and activities of daily living, exceeding the minimal important change. PPT increased at both the knee and forearm, TSP decreased, and physical activity increased. Baseline step count was positively correlated with improvement in KOOS activities of daily living, whereas structural abnormalities and pain sensitization measures were not associated with changes in KOOS outcomes.
Results date posted
| 2026 | Year | 09 | Month | 09 | 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
| 2019 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 06 | Day |
Last modified on
| 2026 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045303
