Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration

Sheba Medical Center

Status: Unknown

Conditions: Knee Pain Chronic

Treatments: Device: pulsed radiofrequency modulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04940832

Knee_pain_radiofrequency

Details and patient eligibility

About

A single blinded randomized controlled trial to compare outcomes of patients with chronic knee pain receiving radiofrequency with or without corticosteroids.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women with pain secondary to osteoarthritis of the knee
• Age of 18 years and up
• Fits criteria for procedure of genicular nerve block and pulsed radiofrequency neuromodulation

Exclusion criteria

• Patients who are incapable of judgment and/or to give informed consent
• Patients who are pregnant
• Patients who are under 18 years old
• Patients who have allergies to local anesthetic
• Patients with platelet dysfunction or bleeding disorders
• Patients who are currently mentally unstable
• Patients who have a diagnosis of fibromyalgia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

radiofrequency with corticosteroids

Active Comparator group

Description:

corticosteroids- 80mg depo-medrol Pulsed radiofrequency to 42 derees celsius for 6 minutes

Treatment:

Device: pulsed radiofrequency modulation

radiofrequency without corticosteroids

Active Comparator group

Description:

Pulsed radiofrequency to 42 derees celsius for 6 minutes

Treatment:

Device: pulsed radiofrequency modulation