An Exploratory Clinical Study on the Efficacy and Safety of Coolief Cooling Radiofrequency Therapy for Chronic Pain after Total Knee Arthroplasty

Matsumoto Tomoyuki0 sites6 target enrollmentNovember 1, 2023

Overview

No summary available.

Registry

who.int

Start Date

November 1, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Matsumoto Tomoyuki

•(1\) Patients with chronic pain lasting more than 6 months in the knee joint after TKA surgery.
•(2\) Patients must be at least 18 years of age, regardless of gender.
•(3\) Patients who have had unsatisfactory results with existing pain relief therapies (Existing pain relief therapy here refers to NSAIDs, steroids, oral opioids, pregabalin, etc.).
•(4\) Patients with at least a 50% reduction in NRS for knee nerve blocks (superior medial, superior lateral, and inferior medial knee nerve).
•(5\) Patients who have given their free and voluntary written consent to participate in this clinical study.

•(1\) Patients with inflammation, etc. (pyogenic arthritis, gout, pseudogout) in the knee joint.
•(2\) Patients with systemic infection.
•(3\) Patients with neurological pre\-existing conditions (diabetic peripheral neuropathy, spondylolisthesis, or spinal fistula).
•(4\) Patients with blood coagulation disorders or using anticoagulants.
•(5\) Patients already receiving CRFA treatment for knee osteoarthritis.
•(6\) Patients using a pacemaker implantable cardioverter\-defibrillator, etc.
•(7\) Other patients deemed inappropriate by the investigators in charge of this clinical study.