RecruitingNot ApplicableNCT02915120

Ultrasound-Guided Pulsed Radiofrequency In The Treatment Of Patients With Osteoarthritis Knee (USPRFGENOAK)

Ultrasound-Guided Pulsed Radiofrequency Of The Genicular Nerves In The Treatment Of Patients With Osteoarthritis Knee Pain: Randomized, Double-Blind, Placebo Controled Trial

Sponsor

Hospital Son Llatzer

Enrollment

142 participants

Start Date

Mar 27, 2017

Study Type

INTERVENTIONAL

Conditions

Osteoarthritis, Knee

Summary

The purpose of this study is to determine if patients with chronic painful knee osteoarthritis experience meaningful and long-term improvement in pain, function, and analgesic use after ultrasound-guided pulsed radiofrequency of the genicular nerves following a double diagnostic genicular nerve blocks.

Eligibility

Min Age: 40 Years

Inclusion Criteria4

Chronic knee pain with pain intensity of at least 4 out 10 on the VAS on most or all days for more than 3 months
Patients of either sex with primary osteoarthritis of one or both knees fulfilling diagnostic criteria for osteoarthritis knee laid down by American College of Rheumatology.
Patients also had to have a Kellgren-Lawrence (radiologic criterion) score of at least 2
Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy, and intra-articular injection therapy.

Exclusion Criteria10

The patients with secondary osteoarthritis of knees
Associated systemic arthropathies, e.g. rheumatoid arthritis and gout
Previous radiofrequency ablation treatment for similar symptoms.
Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months.
Active systemic or local infections at the site of proposed needle and electrode placement.
Coagulopathy or other bleeding disorder
Cognitive deficit.
Unstable medical or psychiatric illness.
Previous knee joint replacement surgery
Patients missing two or more appointments consecutively were excluded from the study

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Interventions

PROCEDUREReal Pulsed Radiofrequency

Pulsed Radiofrequency uses radiofrequency current in short (20 ms), high-voltage bursts; the "silent" phase (480 ms) allows time for heat elimination, generally keeping the target tissue below 42° C. The Radiofrequency (RF) electrode will be inserted through the canula, and RF lesions will be generated by applying pulsed RF treatment to the inferomedial (IM), superomedial (SM), and superolateral (SL) GN branches for 8 minutes at 42°C.

PROCEDURESham Pulsed Radiofrequency

Control patients will undergo the same procedure. The sensorial and motor stimulations will be applied too. The RF electrode will be then inserted through the cannula, and RF lesions will be simulated without applying pulsed RF treatment to the IM, SM and SL, GN branches for 8 minutes each GN branch and the temperature of the electrode tip was not raised.