Cooled Versus Conventional Genicular Radiofrequency Ablation for Chronic Knee Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-11

Study Completion Date

2020-09-24

Brief Summary

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This prospective observational study seeks to compare pain relief and disability following cooled radiofrequency ablation (Coolief) versus conventional genicular nerve ablation in patients with chronic knee pain. Patients' NRS for pain, WOMAC, and ODI score at baseline and 1, 3 and 6 months after treatment will be used to evaluate whether Coolief is more effective at reducing disability and improving pain relief.

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Detailed Description

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This prospective observational study seeks to compare pain relief at 1 month, 3 months and 6 months following cooled radiofrequency ablation vs conventional genicular nerve ablation in patients with chronic knee pain.

Both cooled RF and conventional genicular nerve ablation use the electrical current produced by radio waves to destroy a part of nerve tissue, creating a lesion and relieving pain (Kapural and Mekhail 2001). The conventional probe emanates heat that can damage surrounding tissues, and the lesion produced is limited in size. Cooled radiofrequency (RF) probes have a system of water running through the probe tip that keeps the probe tip at a lower temperature (Lorentzen 2015). Coolief produces larger spherical-shaped lesions, meaning an increased area of nerve destruction with less heat damage to surrounding tissues (Menzies and Hawkins 2015).

In 2017, the FDA cleared the Cooled radiofrequency thermal treatment device (Coolief, Halyard Health, Alpharetta, GA, USA) for knee osteoarthritis. McCormick et al investigated 33 patients with knee osteoarthritis pain, and after 6 months, 35% of patients had at least 50% or greater reduction in Numeric Rating Scale (NRS) for Pain, and 19% had complete pain relief. In another study by Davis et al, they compared, prospective, multicenter, randomized trial of 151 patients that compared cooled radiofrequency ablation genicular against intraarticular steroid injection. At 6 months, the cooled radiofrequency ablation group had more favorable outcomes in NRS: pain reduction 50% or greater was 74.1% in the ablation group versus 16.2% in the intraarticular group. Henry Ford Hospital Pain center introduced cooled radiofrequency ablation treatment modality in 2017 and it's currently being used in patients with chronic knee osteoarthritis and post-surgical knee pain.

This study will follow patients who have been diagnosed with chronic knee osteoarthritis or post-surgical knee pain and are scheduled to undergo Coolief or conventional ablation to treat their chronic knee pain. At 1, 3 and 6 months following their treatment, the study team will call patients on the phone to give them to ask about their pain and disability, using the NRS for pain, WOMAC for knee pain, and ODI questionnaire. Baseline and post-treatment scores will be compared to determine if Coolief elicits a more pronounced impact on reduced pain and disability than the conventional technique.

We expect to find a greater reduction in pain and disability experienced by patients who undergo the newer, cooled radiofrequency ablation when compared to the conventional ablation technique, at 1, 3- and 6-months after the procedure. The information gained from this study will be used to guide future ablation treatment, to ensure that patients receive the most effective pain relief treatment for their chronic knee pain.

Conditions

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Chronic Knee Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Conventional Genicular Ablation

This group is scheduled to receive conventional genicular ablation to treat their chronic knee pain.

Conventional radiofrequency ablation

Intervention Type DEVICE

Genicular nerve ablation involves using radiofrequency to heat up the genicular nerve until it dies, causing relief of pain. This is a minimally invasive treatment that does not require any medication.

Cooled radiofrequency Ablation

This group is scheduled to receive cooled radiofrequency ablation to treat their chronic knee pain.

Cooled radiofrequency ablation

Intervention Type DEVICE

Cooled radiofrequency thermal treatment uses the electrical current produced by radio waves to destroy a part of nerve tissue and relieve pain.

Interventions

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Cooled radiofrequency ablation

Cooled radiofrequency thermal treatment uses the electrical current produced by radio waves to destroy a part of nerve tissue and relieve pain.

Intervention Type DEVICE

Conventional radiofrequency ablation

Genicular nerve ablation involves using radiofrequency to heat up the genicular nerve until it dies, causing relief of pain. This is a minimally invasive treatment that does not require any medication.

Intervention Type DEVICE

Other Intervention Names

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Cooled radiofrequency thermal treatment Genicular ablation Genicular nerve ablation

Eligibility Criteria

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Inclusion Criteria

* Adult male or female (above age of 18)
* Diagnosed with chronic knee osteoarthritis or post Total Knee Arthroscopy or post Total Knee Replacement Pain
* More than 3 months of knee pain
* Scheduled for Genicular Knee ablation (Cooled or conventional ablation)
* Had previous intra articular injection (steroids or Hyaluronic acids) if not a post-surgical knee pain patient
* Achieved minimum 50% relief from genicular block x 2
* Numeric Rating Scale Score of 4 or greater
* Kellgren-Lawrence Knee Osteoarthritis Grade 2 or greater (in non post-surgical patients)

Exclusion Criteria

* Pregnant adult female
* Patient fully anticoagulated
* Antiplatelet Use
* History of Clotting Disorder
* Refusal to participate
* Focal neurologic deficits
* Cognitive deficits
* History of Bone Cancer
* Mental Health Illness which causes instability
* Previous Knee radiofrequency ablation
* Active Infection
* Allergy to Medications Administered

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No