UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055409 |
|---|---|
| Receipt number | R000063322 |
| Scientific Title | Effect of nerve ablation treatment for knee osteoarthritis on neuromuscular activity of the quadriceps femoris muscle |
| Date of disclosure of the study information | 2024/09/03 |
| Last modified on | 2024/09/03 21:26:29 |
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Basic information
Public title
Effect of nerve ablation treatment for knee osteoarthritis on neuromuscular activity of the quadriceps femoris muscle
Acronym
Effect of nerve ablation treatment for knee osteoarthritis on quadriceps muscle activity
Scientific Title
Effect of nerve ablation treatment for knee osteoarthritis on neuromuscular activity of the quadriceps femoris muscle
Scientific Title:Acronym
Effect of Coolief for knee osteoarthritis on neuromuscular activity of quadriceps muscles
Region
| Japan |
Condition
Condition
Knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether nerve ablation treatment for patients with knee osteoarthritis affects neuromuscular activity in the quadriceps muscle
Basic objectives2
Others
Basic objectives -Others
To clarify whether nerve ablation treatment for patients with knee osteoarthritis affects the improvement of motor function
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neuromuscular activity (motor units, firing frequency, firing threshold, etc.)
Key secondary outcomes
Knee extensor strength
Walking speed
Locomotive syndrome assessment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Nerve ablation treatment with Coolief
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Kellgren-Lawrence classification >= 2
Key exclusion criteria
Those unable to fully understand this research method due to cognitive decline
Those with severe pain during muscle strength measurement
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sengoku |
| Middle name | |
| Last name | Takuya |
Organization
Kanazawa university
Division name
Department of Rehabilitation
Zip code
920-8641
Address
Takaramachi 13-1, Kanazawa, Ishikawa, Japan
TEL
076-265-2013
moo.49k.ree@gmail.com
Public contact
Name of contact person
| 1st name | Sengoku |
| Middle name | |
| Last name | Takuya |
Organization
Kanazawa university
Division name
Department of Rehabilitation
Zip code
920-8641
Address
Takaramachi 13-1, Kanazawa, Ishikawa, Japan
TEL
076-265-2013
Homepage URL
moo.49k.ree@gmail.com
Sponsor or person
Institute
Kanazawa university
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
Kanazawa University
Address
Takaramachi 13-1, Kanazawa, Ishikawa, Japan
Tel
0762652110
rinri@adm.kanazawa-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
金沢大学附属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 09 | Month | 03 | Day |
Last modified on
| 2024 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063322
