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Comparison of Heated vs. Pulsed Radiofrequency Treatment of the Genicular Nerves for Osteoarthritis Knee Pain

NCT04379895 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-05-13

No results posted yet for this study

Summary

This is a prospective, randomised, interventional, double blinded study to compare the clinical outcomes of thermal vs. pulsed radiofrequency (RF) treatment of the genicular nerves in patients with painful osteoarthritis (OA) of the knee.

Population: 60 patients, aged 50 and above, with painful OA of the knee. Interventional measures: Pulsed or heated RF treatment of the genicular nerves of the involved knee.

Outcome measures: primary - fraction of patients experiencing improvement of 50% or higher in their average pain rating during stair climbing.

secondary - improved quality of life

* improved functional capacity
* comparison of side effects and adverse events
* change in the consumption of analgesic medications

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

Radiofrequency ablation

Pulsed or heated RF ablation of the genicular nerves will be done as an Acceptable treatment for OA of the knee

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2022-06-30
Completion
2022-08-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04379895 on ClinicalTrials.gov