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Efficacy of Cooled and Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment of Chronic Osteoarthritic Knee Pain

NCT02260869 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2022-04-26

Study results available
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Summary

This is a single center randomized controlled trial. Approximately 102 patients will be randomized to one of two treatment groups: cooled radiofrequency or conventional monopolar radiofrequency ablation. Patients with chronic knee pain, with moderate to severe osteoarthritis according to the Kellgren-Lawrence scale for at least 6 months who have failed conservative therapy will be screened for the study.

Then, patients will be enrolled based on reporting ≥50% pain relief after a fluoroscopic guided single diagnostic block of the geniculate nerves (superior medial, superior lateral, and inferior medial) with 0.5 ml of local anesthetic (2% Lidocaine).

Baseline data will be collected for all enrolled patients. Outcomes will be measured at 1, 4, 12, 24 and 52 weeks.

Outcome measures will be: Visual analogue scale (VAS) both while at rest and during ambulation, Oxford knee scores, WOMAC, and global perceived effect.

Conditions

  • Osteoarthritis, Knee

Interventions

PROCEDURE

Genicular nerve radiofrequency ablation

Radiofrequency ablation uses the electrical field generated by a radiofrequency probe inserted near a nerve responsible for pain. Chronic pain sensation in the knee is generated at the genicular nerves. The physician locates the affected genicular nerve by injecting an anesthetic (lidocaine) that produces a sensory nerve block (i.e. anesthetic pain relief). A radiofrequency probe is inserted percutaneously near the affected nerve using a cannula/introducer and is then connected to a radiofrequency generator. This is set to stimulate sensory and motor response, which allows the physician to adjust the probe position for effective and safe treatment. Then radiofrequency is applied to the tissue for a short time (up to 150 seconds) in order to generate a target temperature (no more than 80 degrees Celsius). The increase in the temperature of the tissue ablates the affected nerve producing pain relief.

DEVICE

Pain Management Radiofrequency Kit

The pain management radiofrequency consists of a radiofrequency generator, a radiofrequency probe and an introducer/cannula. The introducer cannula is used to percutaneously position the probe in the appropriate location for treatment. The radiofrequency probe is an electrode that delivers the electric field that heats up the tissue. In cooled radiofrequency the electrode is surrounded by a water jacket that cools it while heat is generated. The generator is the instrument that provides the radiofrequency according to a particular temperature and time program. Temperature, tissue impedance and radiofrequency power are lalso monitored by the generator.

Sponsors & Collaborators

  • Millennium Pain Center

    lead OTHER

Principal Investigators

  • Ricardo Vallejo, MD, PhD · Millennium Pain Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-10-15
Completion
2019-06-26

Countries

  • United States

Study Locations

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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 NCT02260869 on ClinicalTrials.gov