A Study to Evaluate the Efficacy and Safety of Coolief Cooling Radiofrequency Therapy for Chronic Pain after Total Knee Arthroplasty.

JRCT ID: jRCTs052230123

Registered date:01/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Prolonged Post-surgical Pain
• Date of first enrollment: 01/11/2023
• Target sample size: 6
• Study type: Interventional

Intervention(s)

Protocol treatment should be initiated within 28 days (the same day of the week is acceptable) after enrollment; if it is determined that protocol treatment cannot be initiated after 29 days, the protocol treatment should be discontinued and the details should be noted on the "End of Treatment Report Form" as "Protocol Treatment Discontinued. Protocol treatment is for single use only. All protocol treatments will be performed at Hiro Clinic.
Name of study equipment: Electrosurgical unit for cautery, Coolief high-frequency system for pain management (Avanos Medical Japan Inc.)
Preparation and other details will follow the attached document.
1) Under echo guidance, the Cooled RF introducer ("introducer") is punctured up to the target biological tissue (superior medial knee nerve, superior lateral and inferior medial knee nerves) in the patient's body.
2) The stylet is removed from the cannula and the probe is inserted.
3) Select the electrical stimulation mode (Stimulation).
4) Select the probe channel to be used (A, B, C, or D).
5) Select "Motor 2 Hz" or "Sensory 50 Hz" with the Stimulation mode selection button.
6) Slide the start button to the right to initiate the electrical stimulation mode.
7) Turn the rotary dial on the front of the generator to adjust the output.
8) If multiple probes are used for the superior lateral knee nerve and inferior medial knee nerve, repeat steps 1) to 7).
9) Press the STOP button to terminate the electrical stimulation.

Outcome(s)

• Primary Outcome: Comparison in Numeric Rating Scale (NRS) between pre-treatment and post-6-months-treatment

Secondary Outcome

Efficacy endpoints
Comparison of 2011 Knee Society Score (KSS) between pre-treatment and 6 months post-treatment. The 2011 KSS will be evaluated for each item and for the overall KSS.
2011 KSS items: Knee symptoms, satisfaction, surgical expectations, and activity
The same items for the selected items of activity shall be evaluated before and after the treatment.

Safety endpoints
Occurrence of disease or other conditions that cannot be ruled out to be related to the test device at 6 months after treatment

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(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.

Exclude criteria

(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.

Related Information

• Primary Sponsor: Matsumoto Tomoyuki