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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04940832
Other study ID # Knee_pain_radiofrequency
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date December 2022

Study information

Verified date May 2022
Source Sheba Medical Center
Contact Matthew Medwick, Doctor
Phone 03-5303106
Email matt.medwick@sheba.health.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 2022
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
pulsed 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.

Locations

Country Name City State
Israel Sheba Medical Center Tel Hashomer

Sponsors (1)

Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement in chronic knee pain Measured 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). 2nd and 6th week
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