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

A Single Blinded Randomized Controlled Clinical Trial Comparing Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04940832
Enrollment
40
Registered
2021-06-28
Start date
2022-04-01
Completion date
2022-12-31
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Pain Chronic

Brief summary

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

Interventions

DEVICEpulsed radiofrequency modulation

a percutaneous needle electrode to apply pulsed RF signals that modulate the activity of sensory nerves. The pulsing of the RF signal permits a maximum temperature to be achieved - usually 42 Celsius. This helps prevent collateral damage from occurring during the procedure and should help reduce procedural complications.

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in chronic knee pain2nd and 6th weekMeasured by the Knee injury and Osteoarthritis Outcome Score; higher scores indicating that the patients experiences more impairment (All items are scored 0-4; for each subscale the scores are transformed to a 0-100 scale; 0 representing extreme knee problems and 100 representing no knee problems).

Countries

Israel

Contacts

Primary ContactMatthew Medwick, Doctor
matt.medwick@sheba.health.gov.il03-5303106

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026