Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062017) titled 'A Study Evaluating the Effect of Cooled Radiofrequency Treatment and Rehabilitation for Knee Osteoarthritis Pain' on July 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Kurume Univercity
Condition:
Condition - Knee Osteoarthritis
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - CRFA and Rehabilitation therapy
Interventions/Control_2 - CRFA alone
Eligibility:
Age-lower limit - 20
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 Size - 68
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069403
Disclaimer: Curated by HT Syndication.