UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062017 |
|---|---|
| Receipt number | R000069403 |
| Scientific Title | Clinical Course and Efficacy of Rehabilitation Therapy Following Cooled Radiofrequency Treatment in Patients With Knee Osteoarthritis: A Prospective Multicenter Randomized Controlled Trial (RCT) |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/23 08:24:41 |
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Basic information
Public title
A Study Evaluating the Effect of Cooled Radiofrequency Treatment and Rehabilitation for Knee Osteoarthritis Pain
Acronym
Cool-Knee Trial(Cooled Radiofrequency for Knee Osteoarthritis)
Scientific Title
Clinical Course and Efficacy of Rehabilitation Therapy Following Cooled Radiofrequency Treatment in Patients With Knee Osteoarthritis: A Prospective Multicenter Randomized Controlled Trial (RCT)
Scientific Title:Acronym
Cooled Radiofrequency and Rehabilitation for Knee Osteoarthritis Trial
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to determine whether the addition of rehabilitation therapy after cooled radiofrequency ablation (CRFA) improves knee extensor muscle strength and joint range of motion.
In addition, pain, gait function, physical function, and activities of daily living (ADL) will be comprehensively evaluated, and factors associated with pain recurrence will also be investigated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in knee extensor muscle strength (HHD: body weight adjusted)
Key secondary outcomes
1) Objective Functional Performance
TUG
10m walking speed
Five Times Sit-to-Stand test (5xSTS)
Hip abductor muscle strength (HHD)
Change in joint range of motion (ROM)
VAS
2) Subjective Outcomes (PROMs and Psychological Measures)
WOMAC
TSK
3) General Physical Function, Fitness, and Physical Characteristics
Body composition
Handgrip strength (dominant hand)
4) Imaging and Severity Classification
(Primarily background factors for stratification and covariates)
KL grade (severity)
MRI evaluation (soft tissue, cartilage, bone marrow lesions, etc.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
CRFA and Rehabilitation therapy
Interventions/Control_2
CRFA alone
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Outpatients
Individuals who have provided written informed consent to participate in the study
Key exclusion criteria
In accordance with the Appropriate Use Guidelines for Coolief issued by the Japanese Society of Joint Disorders
Patients with peripheral nerve abnormalities, such as diabetic neuropathy
Patients with a history of neurological disorders, active infection, coagulation disorders, or those receiving anticoagulant therapy
Note: Neurological disorders include peripheral nerve abnormalities such as diabetic neuropathy and severe psychiatric disorders.
Patients who do not demonstrate at least a 50% reduction in the numerical pain rating score following a diagnostic genicular nerve block of the target knee prior to the procedure.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Maki |
Organization
Kurume Univercity
Division name
Department of Orthopaedic Surgery, Rehabilitation Unit
Zip code
830-0011
Address
67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL
0942-35-3311
kurumerehahpdoctor@gmail.com
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Maki |
Organization
Kurume Univercity
Division name
Department of Orthopaedic Surgery, Rehabilitation Unit
Zip code
830-0011
Address
67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL
0942-31-7645
Homepage URL
maki_yuuji@kurume-u.ac.jp
Sponsor or person
Institute
Kurume Univercity
Institute
Department
Personal name
Funding Source
Organization
None
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
Kurume University Medical Ethics Committee
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
Tel
0942-35-3311
i_rinri@kurume-u.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 | 07 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | 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 | 06 | Month | 23 | Day |
Last modified on
| 2026 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069403
